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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01572038
Registration number
NCT01572038
Ethics application status
Date submitted
3/04/2012
Date registered
5/04/2012
Date last updated
25/09/2020
Titles & IDs
Public title
A Study of Pertuzumab in Combination With Trastuzumab (Herceptin) and a Taxane in First-Line Treatment in Participants With Human Epidermal Growth Factor 2 (HER2)-Positive Advanced Breast Cancer
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Scientific title
A Multicenter, Open-Label, Single-Arm Study of Pertuzumab in Combination With Trastuzumab and a Taxane in First Line Treatment of Patients With HER2-Positive Advanced (Metastatic or Locally Recurrent) Breast Cancer
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Secondary ID [1]
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2011-005334-20
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Secondary ID [2]
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MO28047
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Universal Trial Number (UTN)
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Trial acronym
PERUSE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Docetaxel
Treatment: Drugs - Nab-paclitaxel
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Pertuzumab
Treatment: Drugs - Trastuzumab
Experimental: Pertuzumab + Trastuzumab + Taxane - Participants will receive pertuzumab and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first. Taxane chemotherapy can be either docetaxel, paclitaxel or nab-paclitaxel as per investigator's choice.
Treatment: Drugs: Docetaxel
Participants may receive 'docetaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.
Treatment: Drugs: Nab-paclitaxel
Participants may receive 'nab-paclitaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.
Treatment: Drugs: Paclitaxel
Participants may receive 'paclitaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.
Treatment: Drugs: Pertuzumab
Participants will receive pertuzumab 840 milligrams (mg) IV on Day 1 or Day 2 of Cycle 1, followed by 420 mg IV on Day 1 or Day 2 of each subsequent 3-week cycle.
Treatment: Drugs: Trastuzumab
Participants will receive trastuzumab (Herceptin) 8 milligrams per kilogram (mg/kg) IV on Day 1 or Day 2 of Cycle 1, followed by 6 mg/kg IV on Day 1 or Day 2 of each subsequent 3-week cycle, administered in line with the respective product Information and/or recognized clinical practice guidelines.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0)
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Assessment method [1]
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Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade =3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. TEAEs of special interest included LVEF decreased, liver enzymes increased, and suspected transmission of infectious agent by the study drug.
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Timepoint [1]
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From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
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Primary outcome [2]
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Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term)
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Assessment method [2]
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All adverse events leading to death, regardless of whether they were classified as treatment emergent, are listed by system organ class (SOC) and preferred term (PT) according to the Medical Dictionary for Regulatory Activities, version 22.1 (MedDRA version 22.1); PTs that are part of a given SOC are listed in the rows directly below each SOC within the results table. Admin. = administration; Mediast. = mediastinal
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Timepoint [2]
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The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
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Primary outcome [3]
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Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term)
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Assessment method [3]
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All adverse events leading to death, regardless of whether they were classified as treatment emergent, are listed by system organ class (SOC) and preferred term (PT) according to the Medical Dictionary for Regulatory Activities, version 22.1 (MedDRA version 22.1); PTs that are part of a given SOC are listed in the rows directly below each SOC within the results table. Admin. = administration; Mediast. = mediastinal
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Timepoint [3]
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The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
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Primary outcome [4]
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Number of Participants With Grade =3 Treatment-Emergent Adverse Events, Occurring in =1% of Participants by System Organ Class and Preferred Term
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Assessment method [4]
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Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs by system organ class (SOC) and preferred term (PT); PTs that are part of a given SOC are listed in the rows directly below each SOC within the results table. If a participant experienced the same AE at more than one severity grade, only the most severe grade was presented.
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Timepoint [4]
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From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
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Primary outcome [5]
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Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in =10% of Participants by System Organ Class
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Assessment method [5]
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Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the system organ classes are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category.
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Timepoint [5]
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From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
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Primary outcome [6]
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Number of Participants With Grade =3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in =0.5% of Participants by Preferred Term
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Assessment method [6]
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Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the preferred terms are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category.
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Timepoint [6]
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From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
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Primary outcome [7]
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Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in =0.2% of Participants by Preferred Term
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Assessment method [7]
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Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the preferred terms are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category. Discont. = discontinuation; Ptz = pertuzumab; Tax = taxane; Trz = trastuzumab
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Timepoint [7]
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From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
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Primary outcome [8]
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Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in =0.5% of Participants by Preferred Term
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Assessment method [8]
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Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the preferred terms are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category. Interrupt. = interruption; Ptz = pertuzumab; Tax = taxane; Trz = trastuzumab
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Timepoint [8]
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From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
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Primary outcome [9]
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Number of Participants With Treatment-Emergent Adverse Events to Monitor of Any Grade, Occurring in =5% of Participants by Category
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Assessment method [9]
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Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first dose of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, it was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. If a participant had more than one event in a category, they were counted only once in that category. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade =3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. MedDRA version 22.1 was used to code AEs; AEs may fall within multiple categories.
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Timepoint [9]
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From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
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Primary outcome [10]
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Number of Participants With Grade =3 Treatment-Emergent Adverse Events to Monitor, Occurring in =0.5% of Participants by Category and Preferred Term
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Assessment method [10]
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Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first dose of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, it was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. If a participant had more than one event in a category, they were counted only once in that category. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade =3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. MedDRA version 22.1 was used to code AEs; preferred terms (PT) that are part of a given category are listed in the rows directly below each category within the results table.
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Timepoint [10]
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From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
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Primary outcome [11]
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Number of Participants With Treatment-Emergent Adverse Events of Special Interest by Category and Preferred Term
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Assessment method [11]
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Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs of special interest included LVEF decreased, liver enzymes (ALT or AST) increased, and suspected transmission of infectious agent by the study drug. MedDRA version 22.1 was used to code AEs; preferred terms (PT) that are part of a given category are listed in the rows directly below each category within the results table. If a participant experienced more than one event in a category, they were counted only once in that category.
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Timepoint [11]
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From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
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Primary outcome [12]
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Subgroup Analysis by Region of Enrollment: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade =3 TEAEs, and Grade =3 TEAEs Related to Pertuzumab
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Assessment method [12]
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Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.
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Timepoint [12]
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From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
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Primary outcome [13]
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Subgroup Analysis by Age (=65 vs. >65 Years): Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade =3 TEAEs, Any-Grade and Grade =3 TEAEs Related to Pertuzumab, and TEAEs to Monitor
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Assessment method [13]
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Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade =3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent.
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Timepoint [13]
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From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
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Primary outcome [14]
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Subgroup Analysis by Taxane Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade =3 TEAEs, Any-Grade and Grade =3 TEAEs Related to Pertuzumab, and TEAEs to Monitor
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Assessment method [14]
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0
Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade =3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent.
Query!
Timepoint [14]
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From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
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Primary outcome [15]
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Subgroup Analysis by ECOG Performance Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade =3 TEAEs, and Grade =3 TEAEs Related to Pertuzumab
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Assessment method [15]
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0
Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.
Query!
Timepoint [15]
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0
From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
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Primary outcome [16]
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Subgroup Analysis by Visceral Disease at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade =3 TEAEs, and Grade =3 TEAEs Related to Pertuzumab
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Assessment method [16]
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0
Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.
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Timepoint [16]
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From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
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Primary outcome [17]
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Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade =3 TEAEs, and Grade =3 TEAEs Related to Pertuzumab
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Assessment method [17]
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0
Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.
Query!
Timepoint [17]
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0
From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Query!
Primary outcome [18]
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Subgroup Analysis by Hormone Receptor Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade =3 TEAEs, and Grade =3 TEAEs Related to Pertuzumab
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Assessment method [18]
0
0
Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.
Query!
Timepoint [18]
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0
From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Query!
Primary outcome [19]
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0
Subgroup Analysis by Previous Trastuzumab Therapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade =3 TEAEs, and Grade =3 TEAEs Related to Pertuzumab
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Assessment method [19]
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0
Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.
Query!
Timepoint [19]
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0
From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Query!
Primary outcome [20]
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Number of Participants With a Congestive Heart Failure Event
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Assessment method [20]
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0
Congestive heart failure was defined as the Standardised MedDRA Query (SMQ) 'Cardiac failure (wide)' from the Medical Dictionary for Regulatory Activities, version 22.1 (MedDRA version 22.1).
Query!
Timepoint [20]
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0
From Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Query!
Primary outcome [21]
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0
Time to Onset of the First Episode of Congestive Heart Failure
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Assessment method [21]
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Congestive heart failure was defined as SMQ 'Cardiac failure (wide)' from the MedDRA version 22.1. Time to onset of the first episode of congestive heart failure was analyzed using a Kaplan-Meier approach. Participants who did not experience any congestive heart failure at the time of data-cut were censored at the date of the last attended visit whilst on-treatment (including visits up to and including 28 days after last dose of study treatment). Only treatment emergent congestive heart failure events are included.
Query!
Timepoint [21]
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0
From Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Query!
Primary outcome [22]
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0
Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study
Query!
Assessment method [22]
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0
All participants must have had a baseline LVEF =50% to enroll in the study; patients with significant cardiac disease or baseline LVEF below 50% were not eligible for this study. The change from baseline LVEF values were reported at every 3 cycles over the course of the study and at the final treatment, worst treatment, and maximum decrease values. The final treatment value was defined as the last LVEF value observed before all study treatment discontinuation. The worst treatment value was defined as the lowest LVEF value observed before all study treatment discontinuation. The maximum decrease value was defined as the largest decrease of LVEF value from baseline, or minimum increase if a participant's post-baseline LVEF measures were all larger than the baseline value.
Query!
Timepoint [22]
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0
Baseline, predose on Day 1 of every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Query!
Primary outcome [23]
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0
Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study
Query!
Assessment method [23]
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0
All participants must have had a baseline LVEF greater than or equal to (=)50% to enroll in the study; patients with significant cardiac disease or baseline LVEF below 50% were not eligible for this study. The number of participants are reported according to four change from baseline in LVEF value categories over the course of the study: 1) an increase or decrease from baseline LVEF less than (<)10% points or no change in LVEF; 2) an absolute LVEF value <45% points and a decrease from baseline LVEF =10% points to <15% points; 3) an absolute LVEF value <45% points and a decrease from baseline LVEF =15% points; or 4) an absolute LVEF value =45% points and a decrease from baseline LVEF =10% points. BL = baseline; Decr. = decrease; Incr. = increase
Query!
Timepoint [23]
0
0
Baseline, predose on Day 1 of every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Query!
Primary outcome [24]
0
0
Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0
Query!
Assessment method [24]
0
0
Clinical laboratory tests for hematology and coagulation parameters were performed at local laboratories. Laboratory toxicities were defined based on NCI-CTC v4.0 from Grades 1 (least severe) to 4 (most severe). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy.
Query!
Timepoint [24]
0
0
Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Query!
Primary outcome [25]
0
0
Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria
Query!
Assessment method [25]
0
0
Clinical laboratory tests for hematology and coagulation parameters were performed at local laboratories. Laboratory toxicities were defined based on local laboratory normal ranges (for parameters with NCI-CTC grade not defined). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy.
Query!
Timepoint [25]
0
0
Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Query!
Primary outcome [26]
0
0
Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0
Query!
Assessment method [26]
0
0
Clinical laboratory tests for biochemistry parameters were performed at local laboratories. Laboratory toxicities were defined based on NCI-CTC v4.0 from Grades 1 (least severe) to 4 (most severe). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy.
Query!
Timepoint [26]
0
0
Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Query!
Primary outcome [27]
0
0
Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria
Query!
Assessment method [27]
0
0
Clinical laboratory tests for biochemistry parameters were performed at local laboratories. Laboratory toxicities were defined based on local laboratory normal ranges (for parameters with NCI-CTC grade not defined). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy.
Query!
Timepoint [27]
0
0
Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Query!
Secondary outcome [1]
0
0
Progression-Free Survival, as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Query!
Assessment method [1]
0
0
Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression.
Query!
Timepoint [1]
0
0
From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Query!
Secondary outcome [2]
0
0
Subgroup Analysis by Region of Enrollment: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1
Query!
Assessment method [2]
0
0
Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression.
Query!
Timepoint [2]
0
0
From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Query!
Secondary outcome [3]
0
0
Subgroup Analysis by Age (=65 vs. >65 Years): Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1
Query!
Assessment method [3]
0
0
Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression.
Query!
Timepoint [3]
0
0
From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Query!
Secondary outcome [4]
0
0
Subgroup Analysis by ECOG Performance Status at Baseline: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1
Query!
Assessment method [4]
0
0
Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression.
Query!
Timepoint [4]
0
0
From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Query!
Secondary outcome [5]
0
0
Subgroup Analysis by Taxane Chemotherapy: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1
Query!
Assessment method [5]
0
0
Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression.
Query!
Timepoint [5]
0
0
From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Query!
Secondary outcome [6]
0
0
Subgroup Analysis by Visceral Disease at Baseline: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1
Query!
Assessment method [6]
0
0
Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression.
Query!
Timepoint [6]
0
0
From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Query!
Secondary outcome [7]
0
0
Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1
Query!
Assessment method [7]
0
0
Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression.
Query!
Timepoint [7]
0
0
From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Query!
Secondary outcome [8]
0
0
Subgroup Analysis by Hormone Receptor Status at Baseline: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1
Query!
Assessment method [8]
0
0
Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression.
Query!
Timepoint [8]
0
0
From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Query!
Secondary outcome [9]
0
0
Subgroup Analysis by Previous Trastuzumab Therapy: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1
Query!
Assessment method [9]
0
0
Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression.
Query!
Timepoint [9]
0
0
From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Query!
Secondary outcome [10]
0
0
Overall Survival
Query!
Assessment method [10]
0
0
Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation.
Query!
Timepoint [10]
0
0
From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Query!
Secondary outcome [11]
0
0
Subgroup Analysis by Region of Enrollment: Overall Survival
Query!
Assessment method [11]
0
0
Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation.
Query!
Timepoint [11]
0
0
From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Query!
Secondary outcome [12]
0
0
Subgroup Analysis by Age (=65 vs. >65 Years): Overall Survival
Query!
Assessment method [12]
0
0
Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation.
Query!
Timepoint [12]
0
0
From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Query!
Secondary outcome [13]
0
0
Subgroup Analysis by ECOG Performance Status at Baseline: Overall Survival
Query!
Assessment method [13]
0
0
Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation.
Query!
Timepoint [13]
0
0
From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Query!
Secondary outcome [14]
0
0
Subgroup Analysis by Taxane Chemotherapy: Overall Survival
Query!
Assessment method [14]
0
0
Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation.
Query!
Timepoint [14]
0
0
From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Query!
Secondary outcome [15]
0
0
Subgroup Analysis by Visceral Disease at Baseline: Overall Survival
Query!
Assessment method [15]
0
0
Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation.
Query!
Timepoint [15]
0
0
From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Query!
Secondary outcome [16]
0
0
Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Overall Survival
Query!
Assessment method [16]
0
0
Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation.
Query!
Timepoint [16]
0
0
From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Query!
Secondary outcome [17]
0
0
Subgroup Analysis by Hormone Receptor Status at Baseline: Overall Survival
Query!
Assessment method [17]
0
0
Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation.
Query!
Timepoint [17]
0
0
From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Query!
Secondary outcome [18]
0
0
Subgroup Analysis by Previous Trastuzumab Therapy: Overall Survival
Query!
Assessment method [18]
0
0
Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation.
Query!
Timepoint [18]
0
0
From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Query!
Secondary outcome [19]
0
0
Overall Response Rate (Complete Response or Partial Response) Based on Best Overall Response (Confirmed) as Assessed by the Investigator Using RECIST v1.1
Query!
Assessment method [19]
0
0
The overall response rate was defined as the percentage of participants with complete response (CR) or partial response (PR) as their best confirmed response (=4 weeks later), as assessed by the investigator using RECIST v1.1 from the start of study treatment until disease progression/recurrence or death. Responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants without post-baseline tumor assessments were considered non-responders.
Query!
Timepoint [19]
0
0
Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Query!
Secondary outcome [20]
0
0
Percentage of Participants by Best Overall Response as Assessed by the Investigator Using RECIST v1.1
Query!
Assessment method [20]
0
0
Best overall response (BOR) was defined as the best response recorded from the first dose of study treatment until disease progression/recurrence or death in the absence of disease progression. The hierarchy used to determine BOR: Complete Response (CR)>Partial Response (PR)>Stable Disease (SD)>Progressive Disease (PD)>Not Evaluable. Note that CR or PR was confirmed =4 weeks later. RECIST v1.1 responses are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.; PD = At least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study, and absolute increase of =5 mm.; SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Query!
Timepoint [20]
0
0
Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Query!
Secondary outcome [21]
0
0
Subgroup Analysis by Age (=65 vs. >65 Years): Overall Response Rate (Complete Response or Partial Response) Based on Best Overall Response (Confirmed) as Assessed by the Investigator Using RECIST v1.1
Query!
Assessment method [21]
0
0
The overall response rate was defined as the percentage of participants with complete response (CR) or partial response (PR) as their best confirmed response (=4 weeks later), as assessed by the investigator using RECIST v1.1 from the start of study treatment until disease progression/recurrence or death. Responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants without post-baseline tumor assessments were considered non-responders.
Query!
Timepoint [21]
0
0
Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Query!
Secondary outcome [22]
0
0
Subgroup Analysis by Taxane Chemotherapy: Overall Response Rate (Complete Response or Partial Response) Based on Best Overall Response (Confirmed) as Assessed by the Investigator Using RECIST v1.1
Query!
Assessment method [22]
0
0
The overall response rate was defined as the percentage of participants with complete response (CR) or partial response (PR) as their best confirmed response (=4 weeks later), as assessed by the investigator using RECIST v1.1 from the start of study treatment until disease progression/recurrence or death. Responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants without post-baseline tumor assessments were considered non-responders.
Query!
Timepoint [22]
0
0
Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Query!
Secondary outcome [23]
0
0
Clinical Benefit Rate (CR or PR, or SD for at Least 6 Months) Based on Best Overall Response as Assessed by the Investigator Using RECIST v.1.1
Query!
Assessment method [23]
0
0
The clinical benefit rate was defined as the percentage of participants whose best confirmed response (=4 weeks later) was a complete response (CR) or partial response (PR), or stable disease (SD) that lasted at least 6 months, as assessed by the investigator using RECIST v1.1 from the start of study treatment until disease progression/recurrence or death. Clinical benefit responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.; SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least 20% increase in sum of diameters of target lesions and absolute increase of =5 mm), taking as reference the smallest sum diameters while on study.
Query!
Timepoint [23]
0
0
Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Query!
Secondary outcome [24]
0
0
Duration of Response as Assessed by the Investigator Using RECIST v1.1
Query!
Assessment method [24]
0
0
Duration of response (DOR) was defined as the time from when a confirmed best overall response of complete response (CR) or partial response (PR) was first documented to first documented disease progression or death from any cause (whichever occurred first). DOR was analyzed using a Kaplan-Meier approach. Participants who had not progressed or died after having had a confirmed response were censored at the date of their last tumor measurement. Response was assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter until event occurrence or end of study. Responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Query!
Timepoint [24]
0
0
From date of first confirmed response (CR or PR) to first documented disease progression or death from any cause, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Query!
Secondary outcome [25]
0
0
Time to Response for Participants With Best Overall Response of Complete Response or Partial Response, as Assessed by the Investigator Using RECIST v1.1
Query!
Assessment method [25]
0
0
Time to response (TTR) was defined as the time from the first study treatment administration to the date of first confirmed response (CR or PR). TTR was analyzed using a Kaplan-Meier approach. Participants who did not have CR or PR were censored at the date of their last evaluable tumor assessment. Participants for whom no post-baseline tumor assessments were available were censored at Day 1. Responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Query!
Timepoint [25]
0
0
From date of first study treatment until date of first confirmed response (CR or PR). The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Query!
Secondary outcome [26]
0
0
Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study
Query!
Assessment method [26]
0
0
The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. Participants were given a series of statements in each subscale and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B total score, ranging from 0 to 148, was the sum of the scores for each subscale, provided that at least 80% of the items had been answered; a higher score indicated a better quality of life. If any of the 5 subscale scores were missing, the total score was also set to missing. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only.
Query!
Timepoint [26]
0
0
Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Query!
Secondary outcome [27]
0
0
Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study
Query!
Assessment method [27]
0
0
The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. For the physical well-being subscale, participants were given a series of 7 statements and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B physical well-being subscale score, ranging from 0 to 28, was the sum of the scores for each statement only if at least 50% of items had been answered; the higher the score, the better the quality of life. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only.
Query!
Timepoint [27]
0
0
Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Query!
Secondary outcome [28]
0
0
Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study
Query!
Assessment method [28]
0
0
The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. For the social well-being subscale, participants were given a series of 7 statements and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B social well-being subscale score, ranging from 0 to 28, was the sum of the scores for each statement only if at least 50% of items had been answered; the higher the score, the better the quality of life. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only.
Query!
Timepoint [28]
0
0
Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Query!
Secondary outcome [29]
0
0
Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study
Query!
Assessment method [29]
0
0
The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. For the emotional well-being subscale, participants were given a series of 6 statements and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B emotional well-being subscale score, ranging from 0 to 24, was the sum of the scores for each statement only if at least 50% of items had been answered; the higher the score, the better the quality of life. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only.
Query!
Timepoint [29]
0
0
Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Query!
Secondary outcome [30]
0
0
Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study
Query!
Assessment method [30]
0
0
The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. For the functional well-being subscale, participants were given a series of 7 statements and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B functional well-being subscale score, ranging from 0 to 28, was the sum of the scores for each statement only if at least 50% of items had been answered; the higher the score, the better the quality of life. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only.
Query!
Timepoint [30]
0
0
Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Query!
Secondary outcome [31]
0
0
Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study
Query!
Assessment method [31]
0
0
The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. For the breast cancer subscale, participants were given a series of 10 statements and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B breast cancer subscale score, ranging from 0 to 40, was the sum of the scores for each statement only if at least 50% of items had been answered; the higher the score, the better the quality of life. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only.
Query!
Timepoint [31]
0
0
Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Query!
Eligibility
Key inclusion criteria
- Histologically or cytologically confirmed adenocarcinoma of the breast with metastatic
or locally recurrent disease not amenable to curative resection
- HER2-positive breast cancer
- Eastern cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- LVEF of at least 50 percent (%)
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Previous systemic non-hormonal anti-cancer therapy for metastatic or locally recurrent
disease
- Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal
treatment to recurrence less than or equal to (</=) 6 months
- Previous approved or investigative anti-HER2 agents in any breast cancer treatment
setting, except for trastuzumab and/or lapatinib in the adjuvant or neoadjuvant
setting
- Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or
neoadjuvant setting
- History of persistent Grade 2 or higher (National Cancer Institute Common Toxicity
Criteria [NCI-CTC], Version 4.0) hematological toxicity resulting from previous
adjuvant or neoadjuvant therapy
- Central nervous system (CNS) metastases
- Current peripheral neuropathy of Grade 3 or greater (NCI-CTC, version 4.0)
- History of other malignancy within the last 5 years prior to first study drug
administration, except for carcinoma in situ of the cervix or basal cell carcinoma
- Inadequate bone marrow, liver or renal function
- Uncontrolled hypertension
- Hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
N/A
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/06/2012
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
20/09/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1436
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
Canberra Hospital; Medical Oncology - Canberra
Query!
Recruitment hospital [2]
0
0
Royal Prince Alfred Hospital; Medical Oncology - Camperdown
Query!
Recruitment hospital [3]
0
0
HOCA Chermside - Chermside
Query!
Recruitment hospital [4]
0
0
Mater Hospital; Cancer Services - South Brisbane
Query!
Recruitment hospital [5]
0
0
Austin and Repatriation Medical Centre; Cancer Services - Melbourne
Query!
Recruitment hospital [6]
0
0
Royal Melbourne Hospital; Hematology and Medical Oncology - Parkville
Query!
Recruitment postcode(s) [1]
0
0
2606 - Canberra
Query!
Recruitment postcode(s) [2]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [3]
0
0
4032 - Chermside
Query!
Recruitment postcode(s) [4]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [5]
0
0
3084 - Melbourne
Query!
Recruitment postcode(s) [6]
0
0
3052 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
Algeria
Query!
State/province [1]
0
0
Algiers
Query!
Country [2]
0
0
Argentina
Query!
State/province [2]
0
0
La Rioja
Query!
Country [3]
0
0
Argentina
Query!
State/province [3]
0
0
Rosario
Query!
Country [4]
0
0
Austria
Query!
State/province [4]
0
0
Graz
Query!
Country [5]
0
0
Austria
Query!
State/province [5]
0
0
Innsbruck
Query!
Country [6]
0
0
Austria
Query!
State/province [6]
0
0
Linz
Query!
Country [7]
0
0
Austria
Query!
State/province [7]
0
0
Salzburg
Query!
Country [8]
0
0
Austria
Query!
State/province [8]
0
0
Steyr
Query!
Country [9]
0
0
Austria
Query!
State/province [9]
0
0
Wien
Query!
Country [10]
0
0
Belgium
Query!
State/province [10]
0
0
Brussel
Query!
Country [11]
0
0
Belgium
Query!
State/province [11]
0
0
Edegem
Query!
Country [12]
0
0
Belgium
Query!
State/province [12]
0
0
Gent
Query!
Country [13]
0
0
Belgium
Query!
State/province [13]
0
0
Leuven
Query!
Country [14]
0
0
Belgium
Query!
State/province [14]
0
0
Liège
Query!
Country [15]
0
0
Brazil
Query!
State/province [15]
0
0
RJ
Query!
Country [16]
0
0
Brazil
Query!
State/province [16]
0
0
RS
Query!
Country [17]
0
0
Brazil
Query!
State/province [17]
0
0
SP
Query!
Country [18]
0
0
Canada
Query!
State/province [18]
0
0
Alberta
Query!
Country [19]
0
0
Canada
Query!
State/province [19]
0
0
British Columbia
Query!
Country [20]
0
0
Canada
Query!
State/province [20]
0
0
Nova Scotia
Query!
Country [21]
0
0
Canada
Query!
State/province [21]
0
0
Ontario
Query!
Country [22]
0
0
Canada
Query!
State/province [22]
0
0
Quebec
Query!
Country [23]
0
0
China
Query!
State/province [23]
0
0
Beijing
Query!
Country [24]
0
0
China
Query!
State/province [24]
0
0
Chongqing
Query!
Country [25]
0
0
China
Query!
State/province [25]
0
0
Guangzhou
Query!
Country [26]
0
0
China
Query!
State/province [26]
0
0
Harbin
Query!
Country [27]
0
0
China
Query!
State/province [27]
0
0
Nanjing
Query!
Country [28]
0
0
China
Query!
State/province [28]
0
0
Shanghai
Query!
Country [29]
0
0
China
Query!
State/province [29]
0
0
Tianjin
Query!
Country [30]
0
0
China
Query!
State/province [30]
0
0
Xi'an
Query!
Country [31]
0
0
Ecuador
Query!
State/province [31]
0
0
Portoviejo
Query!
Country [32]
0
0
Ecuador
Query!
State/province [32]
0
0
Quito
Query!
Country [33]
0
0
Egypt
Query!
State/province [33]
0
0
Cairo
Query!
Country [34]
0
0
Estonia
Query!
State/province [34]
0
0
Tallinn
Query!
Country [35]
0
0
Estonia
Query!
State/province [35]
0
0
Tartu
Query!
Country [36]
0
0
Finland
Query!
State/province [36]
0
0
Helsinki
Query!
Country [37]
0
0
Finland
Query!
State/province [37]
0
0
Pori
Query!
Country [38]
0
0
Finland
Query!
State/province [38]
0
0
Tampere
Query!
Country [39]
0
0
Finland
Query!
State/province [39]
0
0
Turku
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Amiens
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Angers
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Bordeaux
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Bourg En Bresse
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Dechy
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Dijon
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Hyeres
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
La Chaussee St Victor
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
LeMans
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Lille
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Limoges
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Lyon
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
Marseille
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Mougins
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Paris
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Perpignan
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Reims
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Rennes
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Saint Cloud
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Saint Gregoire
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Saint Herblain
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Strasbourg
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Toulouse
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Valence
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
Valenciennes
Query!
Country [65]
0
0
Germany
Query!
State/province [65]
0
0
Bamberg
Query!
Country [66]
0
0
Germany
Query!
State/province [66]
0
0
Bremen
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
Erlangen
Query!
Country [68]
0
0
Germany
Query!
State/province [68]
0
0
Essen
Query!
Country [69]
0
0
Germany
Query!
State/province [69]
0
0
Esslingen
Query!
Country [70]
0
0
Germany
Query!
State/province [70]
0
0
Frankfurt
Query!
Country [71]
0
0
Germany
Query!
State/province [71]
0
0
Gera
Query!
Country [72]
0
0
Germany
Query!
State/province [72]
0
0
Hamburg
Query!
Country [73]
0
0
Germany
Query!
State/province [73]
0
0
Hannover
Query!
Country [74]
0
0
Germany
Query!
State/province [74]
0
0
Heidelberg
Query!
Country [75]
0
0
Germany
Query!
State/province [75]
0
0
Homburg/Saar
Query!
Country [76]
0
0
Germany
Query!
State/province [76]
0
0
Limburg
Query!
Country [77]
0
0
Germany
Query!
State/province [77]
0
0
Lübeck
Query!
Country [78]
0
0
Germany
Query!
State/province [78]
0
0
Mönchengladbach
Query!
Country [79]
0
0
Germany
Query!
State/province [79]
0
0
München
Query!
Country [80]
0
0
Germany
Query!
State/province [80]
0
0
Neuruppin
Query!
Country [81]
0
0
Germany
Query!
State/province [81]
0
0
Rotenburg/Wümme
Query!
Country [82]
0
0
Germany
Query!
State/province [82]
0
0
Saarbruecken
Query!
Country [83]
0
0
Germany
Query!
State/province [83]
0
0
Torgau
Query!
Country [84]
0
0
Germany
Query!
State/province [84]
0
0
Tübingen
Query!
Country [85]
0
0
Greece
Query!
State/province [85]
0
0
Athens
Query!
Country [86]
0
0
Greece
Query!
State/province [86]
0
0
Crete
Query!
Country [87]
0
0
Greece
Query!
State/province [87]
0
0
Patras
Query!
Country [88]
0
0
Greece
Query!
State/province [88]
0
0
Thessaloniki
Query!
Country [89]
0
0
Greece
Query!
State/province [89]
0
0
????a
Query!
Country [90]
0
0
Greece
Query!
State/province [90]
0
0
?a??sa
Query!
Country [91]
0
0
Hong Kong
Query!
State/province [91]
0
0
Hong Kong
Query!
Country [92]
0
0
Hungary
Query!
State/province [92]
0
0
Budapest
Query!
Country [93]
0
0
Hungary
Query!
State/province [93]
0
0
Debrecen
Query!
Country [94]
0
0
Hungary
Query!
State/province [94]
0
0
Miskolc
Query!
Country [95]
0
0
Hungary
Query!
State/province [95]
0
0
Szeged
Query!
Country [96]
0
0
Israel
Query!
State/province [96]
0
0
Beer Sheva
Query!
Country [97]
0
0
Israel
Query!
State/province [97]
0
0
Haifa
Query!
Country [98]
0
0
Israel
Query!
State/province [98]
0
0
Holon
Query!
Country [99]
0
0
Israel
Query!
State/province [99]
0
0
Jerusalem
Query!
Country [100]
0
0
Israel
Query!
State/province [100]
0
0
Nahariya
Query!
Country [101]
0
0
Israel
Query!
State/province [101]
0
0
Petach Tikva
Query!
Country [102]
0
0
Israel
Query!
State/province [102]
0
0
Ramat Gan
Query!
Country [103]
0
0
Israel
Query!
State/province [103]
0
0
Rehovot
Query!
Country [104]
0
0
Israel
Query!
State/province [104]
0
0
Tel Aviv
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Country [105]
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Israel
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Zerifin
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Italy
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Campania
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Italy
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Emilia-Romagna
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Italy
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Friuli-Venezia Giulia
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Italy
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Lazio
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Italy
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Liguria
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Italy
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Lombardia
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Italy
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Marche
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Italy
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Piemonte
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Italy
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Sicilia
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Italy
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Toscana
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Italy
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Veneto
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Beirut
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Kaunas
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Lithuania
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Vilnius
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Mexico
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D.f.
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Mexico
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Distrito Federal
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Mexico
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Mexico City
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Mexico
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Mexico DF
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Mexico
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Queretaro, Queretaro
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Morocco
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Rabat
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Netherlands
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Alkmaar
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Netherlands
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Dordrecht
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Netherlands
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Eindhoven
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Netherlands
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Groningen
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Netherlands
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Leidschendam
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Netherlands
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Rotterdam
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Netherlands
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Tilburg
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Netherlands
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Venlo
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Pakistan
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Islamabad
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Pakistan
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Lahore
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Peru
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Lima
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Bialystok
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Poland
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Kielce
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Country [139]
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Poland
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Kraków
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Poland
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Lodz
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Country [141]
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Poland
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State/province [141]
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Otwock
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Country [142]
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Poland
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State/province [142]
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Warszawa
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Country [143]
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Portugal
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State/province [143]
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Coimbra
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Country [144]
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Portugal
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State/province [144]
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Evora
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Country [145]
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Portugal
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Lisboa
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Country [146]
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Portugal
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Loures
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Country [147]
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Portugal
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Porto
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Country [148]
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Saudi Arabia
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Riyadh
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Country [149]
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Serbia
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State/province [149]
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Belgrade
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Country [150]
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Serbia
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State/province [150]
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Sremska Kamenica
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Country [151]
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Slovenia
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State/province [151]
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Ljubljana
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Country [152]
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Spain
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State/province [152]
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Alicante
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Country [153]
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Spain
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Asturias
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Country [154]
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Spain
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Barcelona
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Country [155]
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Spain
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State/province [155]
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Cadiz
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Country [156]
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Spain
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State/province [156]
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Castellon
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Country [157]
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Spain
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State/province [157]
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Huesca
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Country [158]
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Spain
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State/province [158]
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0
Islas Baleares
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Country [159]
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Spain
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State/province [159]
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0
LA Coruña
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Country [160]
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Spain
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State/province [160]
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LA Rioja
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Country [161]
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Spain
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State/province [161]
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0
LAS Palmas
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Country [162]
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0
Spain
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State/province [162]
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Madrid
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Country [163]
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0
Spain
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State/province [163]
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0
Navarra
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Country [164]
0
0
Spain
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0
Tarragona
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Country [165]
0
0
Spain
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State/province [165]
0
0
Tenerife
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Country [166]
0
0
Spain
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0
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Valencia
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Country [167]
0
0
Spain
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State/province [167]
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0
Vizcaya
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Country [168]
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0
Spain
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State/province [168]
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Burgos
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Country [169]
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0
Spain
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State/province [169]
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Caceres
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Country [170]
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0
Spain
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Girona
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Country [171]
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0
Spain
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Granada
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Country [172]
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0
Spain
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Guadalajara
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Country [173]
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0
Spain
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Leon
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Country [174]
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0
Spain
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Malaga
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Country [175]
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0
Spain
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Murcia
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Country [176]
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0
Spain
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State/province [176]
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Orense
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Country [177]
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0
Spain
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Salamanca
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Country [178]
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0
Spain
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Sevilla
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Country [179]
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Spain
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State/province [179]
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Valladolid
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Country [180]
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Spain
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Zaragoza
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Country [181]
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Sweden
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Gävle
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0
Sweden
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Göteborg
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Country [183]
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0
Sweden
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Karlstad
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Country [184]
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Sweden
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Lund
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Country [185]
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Sweden
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Vaxjo
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Country [186]
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Sweden
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Västerås
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Country [187]
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0
Turkey
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State/province [187]
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Adana
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Country [188]
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0
Turkey
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State/province [188]
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Antalya
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Country [189]
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0
Turkey
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Bornova, I?zmi?r
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Country [190]
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Turkey
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0
Edirne
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Country [191]
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Turkey
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State/province [191]
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0
Sihhiye/Ankara
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Country [192]
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Ukraine
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State/province [192]
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0
Dnipropetrovsk
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Country [193]
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Ukraine
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Kiev
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Country [194]
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Ukraine
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Lviv
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Country [195]
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Ukraine
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State/province [195]
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Zaporozhye
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Country [196]
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0
United Arab Emirates
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State/province [196]
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Al Ain
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Country [197]
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United Kingdom
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Bath
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Country [198]
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United Kingdom
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Birmingham
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Country [199]
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United Kingdom
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Bristol
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United Kingdom
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Cambridge
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Country [201]
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United Kingdom
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Cardiff
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Country [202]
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United Kingdom
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Coventry
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United Kingdom
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Derby
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Country [204]
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United Kingdom
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Durham
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Country [205]
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United Kingdom
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East Kilbride
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Country [206]
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United Kingdom
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Eastbourne
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Country [207]
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United Kingdom
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Glasgow
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Country [208]
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United Kingdom
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Grimsby
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United Kingdom
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Guildford
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Country [210]
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United Kingdom
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Leeds
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Country [211]
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United Kingdom
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Lindley
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Country [212]
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United Kingdom
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London
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Country [213]
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United Kingdom
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Macclesfield
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United Kingdom
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Manchester
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United Kingdom
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Middlesborough
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Country [216]
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United Kingdom
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New Castle Upon Tyne
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United Kingdom
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Northwood
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United Kingdom
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Oxford
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United Kingdom
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Peterborough
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United Kingdom
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Plymouth
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Country [221]
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United Kingdom
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Somerset
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United Kingdom
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Sutton
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United Kingdom
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Truro
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United Kingdom
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Wishaw
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Uruguay
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Montevideo
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Country [226]
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Venezuela
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State/province [226]
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Caracas
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and
tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane
(docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with
metastatic or locally recurrent HER2-positive breast cancer. Participants will receive
pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3
weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease
progression, or death, whichever occurs first.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01572038
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Clinical Trials
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Address
0
0
Hoffmann-La Roche
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0
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Phone
0
0
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Fax
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Email
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0
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01572038
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