Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01358877
Registration number
NCT01358877
Ethics application status
Date submitted
20/05/2011
Date registered
24/05/2011
Date last updated
14/06/2024
Titles & IDs
Public title
A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer
Query!
Scientific title
A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer
Query!
Secondary ID [1]
0
0
TOC4939G
Query!
Secondary ID [2]
0
0
BO25126
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
APHINITY
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Breast
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - 5-Fluorouracil
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Docetaxel
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Epirubicin
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Pertuzumab
Treatment: Drugs - Placebo
Treatment: Drugs - Trastuzumab
Experimental: Pertuzumab + Trastuzumab + Chemotherapy - Participants will receive pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) intravenously (IV) every 3 weeks (Q3W) for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 once weekly (QW); 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
Placebo comparator: Placebo + Trastuzumab + Chemotherapy - Participants will receive placebo matching to pertuzumab IV Q3W and trastuzumab (8 milligrams per kilogram \[mg/kg\] loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 milligrams per square meter (mg/m\^2) + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 milligrams \[mg\]).
Treatment: Drugs: 5-Fluorouracil
5-Fluorouracil will be administered as per the schedule specified in the respective arm.
Treatment: Drugs: Carboplatin
Carboplatin will be administered as per the schedule specified in the respective arm.
Treatment: Drugs: Cyclophosphamide
Cyclophosphamide will be administered as per the schedule specified in the respective arm.
Treatment: Drugs: Docetaxel
Docetaxel will be administered as per the schedule specified in the respective arm.
Treatment: Drugs: Doxorubicin
Doxorubicin will be administered as per the schedule specified in the respective arm.
Treatment: Drugs: Epirubicin
Epirubicin will be administered as per the schedule specified in the respective arm.
Treatment: Drugs: Paclitaxel
Paclitaxel will be administered as per the schedule specified in the respective arm.
Treatment: Drugs: Pertuzumab
Pertuzumab will be administered as per the schedule specified in the respective arm.
Treatment: Drugs: Placebo
Placebo will be administered as per the schedule specified in the respective arm.
Treatment: Drugs: Trastuzumab
Trastuzumab will be administered as per the schedule specified in the respective arm.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants With Invasive Disease-Free Survival (IDFS) Event (Excluding Second Primary Non-Breast Cancer [SPNBC]), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Query!
Assessment method [1]
0
0
Percentage of participants with IDFS events (excluding SPNBC) is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (that is \[i.e.\], an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including ductal carcinoma in situ \[DCIS\] and lobular carcinoma in situ \[LCIS\]) and non-melanoma skin cancer were excluded as an event.
Query!
Timepoint [1]
0
0
Randomization to the first occurrence of IDFS event (excluding SPNBC) (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
Query!
Primary outcome [2]
0
0
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Query!
Assessment method [2]
0
0
Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (excluding SPNBC) at Year 3 is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancer were excluded as an event.
Query!
Timepoint [2]
0
0
3 years
Query!
Secondary outcome [1]
0
0
Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Query!
Assessment method [1]
0
0
Percentage of participants with IDFS events (including SPNBC) is reported. IDFS-SPNBC event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).
Query!
Timepoint [1]
0
0
Randomization to the first occurrence of IDFS event (including SPNBC) (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
Query!
Secondary outcome [2]
0
0
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Query!
Assessment method [2]
0
0
Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (including SPNBC) at Year 3 is reported. IDFS-SPNBC was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).
Query!
Timepoint [2]
0
0
3 years
Query!
Secondary outcome [3]
0
0
Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Query!
Assessment method [3]
0
0
Percentage of participants with DFS event is reported. DFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS.
Query!
Timepoint [3]
0
0
Randomization to the first occurrence of DFS event (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
Query!
Secondary outcome [4]
0
0
Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Query!
Assessment method [4]
0
0
Kaplan-Meier estimate of the percentage of participants who were DFS event-free at Year 3 is reported. DFS was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS.
Query!
Timepoint [4]
0
0
3 years
Query!
Secondary outcome [5]
0
0
Percentage of Participants Who Died
Query!
Assessment method [5]
0
0
Percentage of participants who died due to any cause is reported.
Query!
Timepoint [5]
0
0
Randomization until death due to any cause (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
Query!
Secondary outcome [6]
0
0
Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at Year 3
Query!
Assessment method [6]
0
0
The Kaplan-Meier approach was used to estimate the percentage of participants who were alive at 3 years.
Query!
Timepoint [6]
0
0
3 years
Query!
Secondary outcome [7]
0
0
Percentage of Participants With Recurrence-Free Interval (RFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Query!
Assessment method [7]
0
0
Percentage of participants with RFI event is reported. RFI event was defined as local, regional or distant breast cancer recurrence.
Query!
Timepoint [7]
0
0
Randomization until local, regional or distant breast cancer recurrence (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
Query!
Secondary outcome [8]
0
0
Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Query!
Assessment method [8]
0
0
Kaplan-Meier estimate of the percentage of participants who were RFI event-free at Year 3 is reported. RFI event was defined as local, regional or distant breast cancer recurrence.
Query!
Timepoint [8]
0
0
3 years
Query!
Secondary outcome [9]
0
0
Percentage of Participants With Distant Recurrence-Free Interval (DRFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Query!
Assessment method [9]
0
0
Percentage of participants with DRFI event is reported. DRFI event was defined as distant breast cancer recurrence.
Query!
Timepoint [9]
0
0
Randomization until distant breast cancer recurrence (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
Query!
Secondary outcome [10]
0
0
Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Query!
Assessment method [10]
0
0
Kaplan-Meier estimate of the percentage of participants who were DRFI event-free at Year 3 is reported. DRFI event was defined as distant breast cancer recurrence.
Query!
Timepoint [10]
0
0
3 years
Query!
Secondary outcome [11]
0
0
Percentage of Participants With Primary Cardiac Event
Query!
Assessment method [11]
0
0
Primary cardiac event was defined as either: Heart Failure (New York Heart Association \[NYHA\] Class III or IV) and a drop in left ventricular ejection fraction (LVEF) of at least 10 ejection fraction (EF) points from baseline and to below 50 percent (%); or cardiac death. Cardiac death was defined as either definite cardiac death: due to heart failure, myocardial infarction, or documented primary arrhythmia; or probable cardiac death: sudden unexpected death within 24 hours of a definite or probable cardiac event (e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology.
Query!
Timepoint [11]
0
0
Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months)
Query!
Secondary outcome [12]
0
0
Percentage of Participants With Secondary Cardiac Event
Query!
Assessment method [12]
0
0
Secondary cardiac event was defined as asymptomatic or mildly symptomatic (NYHA Class II) significant drop in LVEF (defined as an absolute decrease of at least 10 EF points from baseline and to below 50%), confirmed by a second LVEF assessment within approximately three weeks of the first significant LVEF assessment or confirmed by the Cardiac Advisory Board (CAB).
Query!
Timepoint [12]
0
0
Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months)
Query!
Secondary outcome [13]
0
0
Change From Baseline in LVEF to Worst Post-Baseline Value
Query!
Assessment method [13]
0
0
LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart. Baseline LVEF value and the maximum absolute decrease (worst value) in LVEF measurement from baseline were reported. LVEF was measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan.
Query!
Timepoint [13]
0
0
Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months)
Query!
Secondary outcome [14]
0
0
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score
Query!
Assessment method [14]
0
0
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting \[N/V\], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, used 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100, with a high score indicating better GHS/QOL. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement.
Query!
Timepoint [14]
0
0
Baseline, Weeks 13, 25; end of treatment (EOT, 28 days after the last dose, up to Week 56); Follow-up (FU) Months 18, 24, 36
Query!
Secondary outcome [15]
0
0
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores
Query!
Assessment method [15]
0
0
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 functioning scores were linearly transformed on a scale of 0 to 100, with a high score indicating better functioning/support. Negative change from Baseline values indicated deterioration in functioning and positive values indicated improvement.
Query!
Timepoint [15]
0
0
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Query!
Secondary outcome [16]
0
0
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores
Query!
Assessment method [16]
0
0
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting \[N/V\], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 disease/treatment-related symptom scores were linearly transformed on a scale of 0 to 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicated improvement in symptoms and positive values indicated worsening of symptoms.
Query!
Timepoint [16]
0
0
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Query!
Secondary outcome [17]
0
0
Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores
Query!
Assessment method [17]
0
0
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 financial difficulties scores were linearly transformed on a scale of 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicated improvement in financial difficulties and positive values indicated worsening of financial difficulties.
Query!
Timepoint [17]
0
0
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Query!
Secondary outcome [18]
0
0
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score
Query!
Assessment method [18]
0
0
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective \[FP\]) and four symptom scales (systemic side effects \[SE\], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL.
Query!
Timepoint [18]
0
0
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Query!
Secondary outcome [19]
0
0
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score
Query!
Assessment method [19]
0
0
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective \[FP\]) and four symptom scales (systemic side effects \[SE\], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for symptom scale indicated high level of symptomatology/problems/greater degree of symptoms. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL.
Query!
Timepoint [19]
0
0
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Query!
Secondary outcome [20]
0
0
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain
Query!
Assessment method [20]
0
0
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems \[scored as 1\], some or moderate problems \[scored as 2\], and extreme problems \[scored as 3\]). Percentage of participants with each of the following responses in mobility domain was reported: I have no problems in walking about; I have some problems in walking about; and I am confined to bed. Response percentages may not add up to 100% due to data rounding.
Query!
Timepoint [20]
0
0
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Query!
Secondary outcome [21]
0
0
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain
Query!
Assessment method [21]
0
0
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems \[scored as 1\], some or moderate problems \[scored as 2\], and extreme problems \[scored as 3\]). Percentage of participants with each of the following responses in self-care domain was reported: I have no problems with self-care; I have some problems washing or dressing myself; and I am unable to wash or dress myself. Response percentages may not add up to 100% due to data rounding.
Query!
Timepoint [21]
0
0
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Query!
Secondary outcome [22]
0
0
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain
Query!
Assessment method [22]
0
0
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems \[scored as 1\], some or moderate problems \[scored as 2\], and extreme problems \[scored as 3\]). Percentage of participants with each of the following responses in usual activities domain was reported: I have no problems with performing my usual activities; I have some problems with performing my usual activities; and I am unable to perform my usual activities. Response percentages may not add up to 100% due to data rounding.
Query!
Timepoint [22]
0
0
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Query!
Secondary outcome [23]
0
0
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain
Query!
Assessment method [23]
0
0
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems \[scored as 1\], some or moderate problems \[scored as 2\], and extreme problems \[scored as 3\]). Percentage of participants with each of the following responses in pain/discomfort domain was reported: I have no pain or discomfort; I have moderate pain or discomfort; and I have extreme pain or discomfort. Response percentages may not add up to 100% due to data rounding.
Query!
Timepoint [23]
0
0
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Query!
Secondary outcome [24]
0
0
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain
Query!
Assessment method [24]
0
0
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems \[scored as 1\], some or moderate problems \[scored as 2\], and extreme problems \[scored as 3\]). Percentage of participants with each of the following responses in anxiety/depression domain was reported: I am not anxious or depressed; I am moderately anxious or depressed; and I am extremely anxious or depressed. Response percentages may not add up to 100% due to data rounding.
Query!
Timepoint [24]
0
0
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Query!
Secondary outcome [25]
0
0
Trough Serum Concentration (Cmin) of Pertuzumab
Query!
Assessment method [25]
0
0
Query!
Timepoint [25]
0
0
Cycles 1, 10 and 15 (Cycle length=21 days)
Query!
Secondary outcome [26]
0
0
Cmin of Trastuzumab
Query!
Assessment method [26]
0
0
Query!
Timepoint [26]
0
0
Cycles 1, 10 and 15 (Cycle length=21 days)
Query!
Secondary outcome [27]
0
0
Peak Serum Concentration (Cmax) of Pertuzumab
Query!
Assessment method [27]
0
0
Query!
Timepoint [27]
0
0
Cycles 1, 10 and 15 (Cycle length=21 days)
Query!
Secondary outcome [28]
0
0
Cmax of Trastuzumab
Query!
Assessment method [28]
0
0
Query!
Timepoint [28]
0
0
Cycles 1, 10 and 15 (Cycle length=21 days)
Query!
Eligibility
Key inclusion criteria
* Non-metastatic operable primary invasive HER2-positive carcinoma of the breast that is histologically confirmed, and adequately excised
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (</=) 1
* Known hormone receptor status (estrogen receptor and progesterone receptor)
* The interval between definitive surgery for breast cancer and the first dose of chemotherapy must be no more than 8 weeks (56 days). The first cycle of chemotherapy must be administered within 7 days of randomization or on Day 56, whichever occurs first
* Baseline left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 55 percent (%) measured by echocardiogram (ECHO) or Multiple-Gated Acquisition (MUGA) Scan
* Confirmed HER2 positive status
* Completion of all necessary baseline laboratory and radiologic investigations prior to randomization
* Women of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception (as defined by the protocol) by the participant and/or partner for the duration of the study treatment and for at least 7 months after the last dose of study drug
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
* History of any prior (ipsi- and/or contralateral) invasive breast cancer
* History of non-breast malignancies within the 5 years prior to study entry, except for carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin
* Any "clinical" T4 tumor as defined by primary tumor/regional lymph nodes/distant metastasis (TNM), including inflammatory breast cancer
* Any node-negative tumor
* Any previous systemic chemotherapy for cancer or radiotherapy for cancer
* Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for cancer
* Concurrent anti-cancer treatment in another investigational trial
* Serious cardiac or cardiovascular disease or condition
* Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions/illness
* Abnormal laboratory tests immediately prior to randomization
* Pregnant or lactating women
* Sensitivity to any of the study medications or any of the ingredients or excipients of these medications
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
8/11/2011
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
28/11/2024
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
4804
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Query!
Recruitment hospital [1]
0
0
Lismore Base Hospital; Cancer Care & Haematology Unit - Lismore
Query!
Recruitment hospital [2]
0
0
Mater Misericordiae Hospital; Chemotherapy Cottage - Sydney
Query!
Recruitment hospital [3]
0
0
Newcastle Mater Misericordiae Hospital; Oncology - Waratah
Query!
Recruitment hospital [4]
0
0
Westmead Hospital; Medical Oncology and Pallative Care - Westmead
Query!
Recruitment hospital [5]
0
0
Wesley Medical Centre; Clinic For Haematology and Oncology - Auchenflower
Query!
Recruitment hospital [6]
0
0
Mater Hospital; Oncology - Brisbane
Query!
Recruitment hospital [7]
0
0
Royal Adelaide Hospital; Oncology - Adelaide
Query!
Recruitment hospital [8]
0
0
Royal Hobart Hospital; Medical Oncology - Hobart
Query!
Recruitment hospital [9]
0
0
Monash Medical Centre; Oncology - Clayton
Query!
Recruitment hospital [10]
0
0
Geelong Hospital; Andrew Love Cancer Centre - Geelong
Query!
Recruitment hospital [11]
0
0
Austin Hospital; Medical Oncology - Heidelberg
Query!
Recruitment hospital [12]
0
0
Peter Maccallum Cancer Institute; Medical Oncology - Melbourne
Query!
Recruitment hospital [13]
0
0
Sir Charles Gairdner Hospital; Medical Oncology - Perth
Query!
Recruitment postcode(s) [1]
0
0
2480 - Lismore
Query!
Recruitment postcode(s) [2]
0
0
2060 - Sydney
Query!
Recruitment postcode(s) [3]
0
0
2298 - Waratah
Query!
Recruitment postcode(s) [4]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [5]
0
0
4066 - Auchenflower
Query!
Recruitment postcode(s) [6]
0
0
4101 - Brisbane
Query!
Recruitment postcode(s) [7]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [8]
0
0
7000 - Hobart
Query!
Recruitment postcode(s) [9]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [10]
0
0
3220 - Geelong
Query!
Recruitment postcode(s) [11]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [12]
0
0
3000 - Melbourne
Query!
Recruitment postcode(s) [13]
0
0
6009 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
District of Columbia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Idaho
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Illinois
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Iowa
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Kansas
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Louisiana
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Maine
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Maryland
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Massachusetts
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Michigan
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Minnesota
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Mississippi
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Missouri
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Nebraska
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
New Hampshire
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
New Jersey
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
New York
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
North Carolina
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Ohio
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Oregon
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Pennsylvania
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
South Carolina
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
South Dakota
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Tennessee
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Texas
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Utah
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
Virginia
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
Washington
Query!
Country [35]
0
0
United States of America
Query!
State/province [35]
0
0
West Virginia
Query!
Country [36]
0
0
United States of America
Query!
State/province [36]
0
0
Wisconsin
Query!
Country [37]
0
0
Argentina
Query!
State/province [37]
0
0
San Miguel de Tucuman
Query!
Country [38]
0
0
Argentina
Query!
State/province [38]
0
0
Santa Fe
Query!
Country [39]
0
0
Austria
Query!
State/province [39]
0
0
Graz
Query!
Country [40]
0
0
Austria
Query!
State/province [40]
0
0
Innsbruck
Query!
Country [41]
0
0
Austria
Query!
State/province [41]
0
0
Linz
Query!
Country [42]
0
0
Austria
Query!
State/province [42]
0
0
Rankweil
Query!
Country [43]
0
0
Austria
Query!
State/province [43]
0
0
Salzburg
Query!
Country [44]
0
0
Austria
Query!
State/province [44]
0
0
St Veit An Der Glan
Query!
Country [45]
0
0
Austria
Query!
State/province [45]
0
0
Vöcklabruck
Query!
Country [46]
0
0
Austria
Query!
State/province [46]
0
0
Wels
Query!
Country [47]
0
0
Austria
Query!
State/province [47]
0
0
Wien
Query!
Country [48]
0
0
Belgium
Query!
State/province [48]
0
0
Anderlecht
Query!
Country [49]
0
0
Belgium
Query!
State/province [49]
0
0
Charleroi
Query!
Country [50]
0
0
Belgium
Query!
State/province [50]
0
0
Edegem
Query!
Country [51]
0
0
Belgium
Query!
State/province [51]
0
0
Hasselt
Query!
Country [52]
0
0
Belgium
Query!
State/province [52]
0
0
Kortrijk
Query!
Country [53]
0
0
Belgium
Query!
State/province [53]
0
0
Leuven
Query!
Country [54]
0
0
Belgium
Query!
State/province [54]
0
0
Liège
Query!
Country [55]
0
0
Belgium
Query!
State/province [55]
0
0
Namur
Query!
Country [56]
0
0
Belgium
Query!
State/province [56]
0
0
Wilrijk
Query!
Country [57]
0
0
Bulgaria
Query!
State/province [57]
0
0
Sofia
Query!
Country [58]
0
0
Bulgaria
Query!
State/province [58]
0
0
Varna
Query!
Country [59]
0
0
Canada
Query!
State/province [59]
0
0
Alberta
Query!
Country [60]
0
0
Canada
Query!
State/province [60]
0
0
British Columbia
Query!
Country [61]
0
0
Canada
Query!
State/province [61]
0
0
Manitoba
Query!
Country [62]
0
0
Canada
Query!
State/province [62]
0
0
New Brunswick
Query!
Country [63]
0
0
Canada
Query!
State/province [63]
0
0
Nova Scotia
Query!
Country [64]
0
0
Canada
Query!
State/province [64]
0
0
Ontario
Query!
Country [65]
0
0
Canada
Query!
State/province [65]
0
0
Quebec
Query!
Country [66]
0
0
Canada
Query!
State/province [66]
0
0
Saskatchewan
Query!
Country [67]
0
0
Chile
Query!
State/province [67]
0
0
Providencia
Query!
Country [68]
0
0
Chile
Query!
State/province [68]
0
0
Santiago
Query!
Country [69]
0
0
China
Query!
State/province [69]
0
0
Beijing
Query!
Country [70]
0
0
China
Query!
State/province [70]
0
0
Changchun
Query!
Country [71]
0
0
China
Query!
State/province [71]
0
0
Changsha
Query!
Country [72]
0
0
China
Query!
State/province [72]
0
0
Chengdu
Query!
Country [73]
0
0
China
Query!
State/province [73]
0
0
Fuzhou City
Query!
Country [74]
0
0
China
Query!
State/province [74]
0
0
Fuzhou
Query!
Country [75]
0
0
China
Query!
State/province [75]
0
0
Guangzhou City
Query!
Country [76]
0
0
China
Query!
State/province [76]
0
0
Guangzhou
Query!
Country [77]
0
0
China
Query!
State/province [77]
0
0
Hangzhou
Query!
Country [78]
0
0
China
Query!
State/province [78]
0
0
Harbin
Query!
Country [79]
0
0
China
Query!
State/province [79]
0
0
Nanchang
Query!
Country [80]
0
0
China
Query!
State/province [80]
0
0
Shanghai City
Query!
Country [81]
0
0
China
Query!
State/province [81]
0
0
Shanghai
Query!
Country [82]
0
0
China
Query!
State/province [82]
0
0
Shijiazhuang
Query!
Country [83]
0
0
China
Query!
State/province [83]
0
0
Wuhan
Query!
Country [84]
0
0
Colombia
Query!
State/province [84]
0
0
Bogota
Query!
Country [85]
0
0
Colombia
Query!
State/province [85]
0
0
Medellin
Query!
Country [86]
0
0
Colombia
Query!
State/province [86]
0
0
Monteria
Query!
Country [87]
0
0
Croatia
Query!
State/province [87]
0
0
Split
Query!
Country [88]
0
0
Croatia
Query!
State/province [88]
0
0
Varazdin
Query!
Country [89]
0
0
Croatia
Query!
State/province [89]
0
0
Zagreb
Query!
Country [90]
0
0
Czechia
Query!
State/province [90]
0
0
Brno
Query!
Country [91]
0
0
Czechia
Query!
State/province [91]
0
0
Hradec Kralove
Query!
Country [92]
0
0
Czechia
Query!
State/province [92]
0
0
Olomouc
Query!
Country [93]
0
0
Czechia
Query!
State/province [93]
0
0
Pardubice
Query!
Country [94]
0
0
Denmark
Query!
State/province [94]
0
0
Aalborg
Query!
Country [95]
0
0
Denmark
Query!
State/province [95]
0
0
Esbjerg
Query!
Country [96]
0
0
Denmark
Query!
State/province [96]
0
0
Herlev
Query!
Country [97]
0
0
Denmark
Query!
State/province [97]
0
0
Hillerod
Query!
Country [98]
0
0
Denmark
Query!
State/province [98]
0
0
København Ø
Query!
Country [99]
0
0
Denmark
Query!
State/province [99]
0
0
Naestved
Query!
Country [100]
0
0
Denmark
Query!
State/province [100]
0
0
Odense C
Query!
Country [101]
0
0
Denmark
Query!
State/province [101]
0
0
Roskilde
Query!
Country [102]
0
0
Denmark
Query!
State/province [102]
0
0
Vejle
Query!
Country [103]
0
0
El Salvador
Query!
State/province [103]
0
0
Salvador
Query!
Country [104]
0
0
El Salvador
Query!
State/province [104]
0
0
San Salvador
Query!
Country [105]
0
0
France
Query!
State/province [105]
0
0
Amiens
Query!
Country [106]
0
0
France
Query!
State/province [106]
0
0
Angers
Query!
Country [107]
0
0
France
Query!
State/province [107]
0
0
Arras
Query!
Country [108]
0
0
France
Query!
State/province [108]
0
0
Avignon
Query!
Country [109]
0
0
France
Query!
State/province [109]
0
0
Bezannes
Query!
Country [110]
0
0
France
Query!
State/province [110]
0
0
Bordeaux
Query!
Country [111]
0
0
France
Query!
State/province [111]
0
0
Brest
Query!
Country [112]
0
0
France
Query!
State/province [112]
0
0
Caen
Query!
Country [113]
0
0
France
Query!
State/province [113]
0
0
Clermont Ferrand
Query!
Country [114]
0
0
France
Query!
State/province [114]
0
0
Dechy
Query!
Country [115]
0
0
France
Query!
State/province [115]
0
0
Dijon
Query!
Country [116]
0
0
France
Query!
State/province [116]
0
0
Grenoble
Query!
Country [117]
0
0
France
Query!
State/province [117]
0
0
La Roche Sur Yon
Query!
Country [118]
0
0
France
Query!
State/province [118]
0
0
Le Havre
Query!
Country [119]
0
0
France
Query!
State/province [119]
0
0
Lille
Query!
Country [120]
0
0
France
Query!
State/province [120]
0
0
Limoges
Query!
Country [121]
0
0
France
Query!
State/province [121]
0
0
Lyon
Query!
Country [122]
0
0
France
Query!
State/province [122]
0
0
Marseille
Query!
Country [123]
0
0
France
Query!
State/province [123]
0
0
Montpellier
Query!
Country [124]
0
0
France
Query!
State/province [124]
0
0
Nancy
Query!
Country [125]
0
0
France
Query!
State/province [125]
0
0
Nice
Query!
Country [126]
0
0
France
Query!
State/province [126]
0
0
Nimes
Query!
Country [127]
0
0
France
Query!
State/province [127]
0
0
Paris
Query!
Country [128]
0
0
France
Query!
State/province [128]
0
0
Perigueux
Query!
Country [129]
0
0
France
Query!
State/province [129]
0
0
Plerin
Query!
Country [130]
0
0
France
Query!
State/province [130]
0
0
Poitiers
Query!
Country [131]
0
0
France
Query!
State/province [131]
0
0
Reims
Query!
Country [132]
0
0
France
Query!
State/province [132]
0
0
Rennes
Query!
Country [133]
0
0
France
Query!
State/province [133]
0
0
Rouen
Query!
Country [134]
0
0
France
Query!
State/province [134]
0
0
Saint Herblain
Query!
Country [135]
0
0
France
Query!
State/province [135]
0
0
Saint-Priest en Jarez
Query!
Country [136]
0
0
France
Query!
State/province [136]
0
0
St Cloud
Query!
Country [137]
0
0
France
Query!
State/province [137]
0
0
Strasbourg
Query!
Country [138]
0
0
France
Query!
State/province [138]
0
0
Toulouse
Query!
Country [139]
0
0
France
Query!
State/province [139]
0
0
Vandoeuvre-les-nancy
Query!
Country [140]
0
0
France
Query!
State/province [140]
0
0
Villejuif
Query!
Country [141]
0
0
Germany
Query!
State/province [141]
0
0
Amberg
Query!
Country [142]
0
0
Germany
Query!
State/province [142]
0
0
Bad Nauheim
Query!
Country [143]
0
0
Germany
Query!
State/province [143]
0
0
Bergisch Gladbach
Query!
Country [144]
0
0
Germany
Query!
State/province [144]
0
0
Berlin
Query!
Country [145]
0
0
Germany
Query!
State/province [145]
0
0
Bielefeld
Query!
Country [146]
0
0
Germany
Query!
State/province [146]
0
0
Bonn
Query!
Country [147]
0
0
Germany
Query!
State/province [147]
0
0
Braunschweig
Query!
Country [148]
0
0
Germany
Query!
State/province [148]
0
0
Bremen
Query!
Country [149]
0
0
Germany
Query!
State/province [149]
0
0
Böblingen
Query!
Country [150]
0
0
Germany
Query!
State/province [150]
0
0
Chemnitz
Query!
Country [151]
0
0
Germany
Query!
State/province [151]
0
0
Deggendorf
Query!
Country [152]
0
0
Germany
Query!
State/province [152]
0
0
Dortmund
Query!
Country [153]
0
0
Germany
Query!
State/province [153]
0
0
Dresden
Query!
Country [154]
0
0
Germany
Query!
State/province [154]
0
0
Düsseldorf
Query!
Country [155]
0
0
Germany
Query!
State/province [155]
0
0
Erfurt
Query!
Country [156]
0
0
Germany
Query!
State/province [156]
0
0
Erlangen
Query!
Country [157]
0
0
Germany
Query!
State/province [157]
0
0
Esslingen
Query!
Country [158]
0
0
Germany
Query!
State/province [158]
0
0
Frankfurt am Main
Query!
Country [159]
0
0
Germany
Query!
State/province [159]
0
0
Frankfurt
Query!
Country [160]
0
0
Germany
Query!
State/province [160]
0
0
Freiburg
Query!
Country [161]
0
0
Germany
Query!
State/province [161]
0
0
Fürth
Query!
Country [162]
0
0
Germany
Query!
State/province [162]
0
0
Greifswald
Query!
Country [163]
0
0
Germany
Query!
State/province [163]
0
0
Halle
Query!
Country [164]
0
0
Germany
Query!
State/province [164]
0
0
Hamburg
Query!
Country [165]
0
0
Germany
Query!
State/province [165]
0
0
Hameln
Query!
Country [166]
0
0
Germany
Query!
State/province [166]
0
0
Hannover
Query!
Country [167]
0
0
Germany
Query!
State/province [167]
0
0
Heidelberg
Query!
Country [168]
0
0
Germany
Query!
State/province [168]
0
0
Hildesheim
Query!
Country [169]
0
0
Germany
Query!
State/province [169]
0
0
Homburg/Saar
Query!
Country [170]
0
0
Germany
Query!
State/province [170]
0
0
Karlsruhe
Query!
Country [171]
0
0
Germany
Query!
State/province [171]
0
0
Kassel
Query!
Country [172]
0
0
Germany
Query!
State/province [172]
0
0
Kiel
Query!
Country [173]
0
0
Germany
Query!
State/province [173]
0
0
Koeln
Query!
Country [174]
0
0
Germany
Query!
State/province [174]
0
0
Köln
Query!
Country [175]
0
0
Germany
Query!
State/province [175]
0
0
Landshut
Query!
Country [176]
0
0
Germany
Query!
State/province [176]
0
0
Leipzig
Query!
Country [177]
0
0
Germany
Query!
State/province [177]
0
0
Ludwigsfelde
Query!
Country [178]
0
0
Germany
Query!
State/province [178]
0
0
Lübeck
Query!
Country [179]
0
0
Germany
Query!
State/province [179]
0
0
Mainz
Query!
Country [180]
0
0
Germany
Query!
State/province [180]
0
0
Muenchen
Query!
Country [181]
0
0
Germany
Query!
State/province [181]
0
0
Mönchengladbach
Query!
Country [182]
0
0
Germany
Query!
State/province [182]
0
0
München
Query!
Country [183]
0
0
Germany
Query!
State/province [183]
0
0
Münster
Query!
Country [184]
0
0
Germany
Query!
State/province [184]
0
0
Offenbach
Query!
Country [185]
0
0
Germany
Query!
State/province [185]
0
0
Oldenburg
Query!
Country [186]
0
0
Germany
Query!
State/province [186]
0
0
Ravensburg
Query!
Country [187]
0
0
Germany
Query!
State/province [187]
0
0
Recklinghausen
Query!
Country [188]
0
0
Germany
Query!
State/province [188]
0
0
Rosenheim
Query!
Country [189]
0
0
Germany
Query!
State/province [189]
0
0
Rostock
Query!
Country [190]
0
0
Germany
Query!
State/province [190]
0
0
Stade
Query!
Country [191]
0
0
Germany
Query!
State/province [191]
0
0
Trier
Query!
Country [192]
0
0
Germany
Query!
State/province [192]
0
0
Tübingen
Query!
Country [193]
0
0
Germany
Query!
State/province [193]
0
0
Ulm
Query!
Country [194]
0
0
Germany
Query!
State/province [194]
0
0
Velbert
Query!
Country [195]
0
0
Germany
Query!
State/province [195]
0
0
Villingen-Schwenningen
Query!
Country [196]
0
0
Germany
Query!
State/province [196]
0
0
Wiesbaden
Query!
Country [197]
0
0
Germany
Query!
State/province [197]
0
0
Witten
Query!
Country [198]
0
0
Germany
Query!
State/province [198]
0
0
Würzburg
Query!
Country [199]
0
0
Guatemala
Query!
State/province [199]
0
0
Guatemala City
Query!
Country [200]
0
0
Guatemala
Query!
State/province [200]
0
0
Guatemala
Query!
Country [201]
0
0
Hong Kong
Query!
State/province [201]
0
0
Hong Kong
Query!
Country [202]
0
0
Hungary
Query!
State/province [202]
0
0
Budapest
Query!
Country [203]
0
0
Hungary
Query!
State/province [203]
0
0
Debrecen
Query!
Country [204]
0
0
Hungary
Query!
State/province [204]
0
0
Gyor
Query!
Country [205]
0
0
Hungary
Query!
State/province [205]
0
0
Gyula
Query!
Country [206]
0
0
Hungary
Query!
State/province [206]
0
0
Kecskemet
Query!
Country [207]
0
0
Hungary
Query!
State/province [207]
0
0
Szeged
Query!
Country [208]
0
0
Hungary
Query!
State/province [208]
0
0
Veszprem
Query!
Country [209]
0
0
Ireland
Query!
State/province [209]
0
0
Cork
Query!
Country [210]
0
0
Ireland
Query!
State/province [210]
0
0
Dublin
Query!
Country [211]
0
0
Ireland
Query!
State/province [211]
0
0
Galway
Query!
Country [212]
0
0
Ireland
Query!
State/province [212]
0
0
Limerick
Query!
Country [213]
0
0
Israel
Query!
State/province [213]
0
0
Haifa
Query!
Country [214]
0
0
Israel
Query!
State/province [214]
0
0
Petach Tikva
Query!
Country [215]
0
0
Israel
Query!
State/province [215]
0
0
Ramat Gan
Query!
Country [216]
0
0
Israel
Query!
State/province [216]
0
0
Rehovot
Query!
Country [217]
0
0
Israel
Query!
State/province [217]
0
0
Tel Aviv
Query!
Country [218]
0
0
Italy
Query!
State/province [218]
0
0
Calabria
Query!
Country [219]
0
0
Italy
Query!
State/province [219]
0
0
Campania
Query!
Country [220]
0
0
Italy
Query!
State/province [220]
0
0
Emilia-Romagna
Query!
Country [221]
0
0
Italy
Query!
State/province [221]
0
0
Friuli-Venezia Giulia
Query!
Country [222]
0
0
Italy
Query!
State/province [222]
0
0
Lazio
Query!
Country [223]
0
0
Italy
Query!
State/province [223]
0
0
Liguria
Query!
Country [224]
0
0
Italy
Query!
State/province [224]
0
0
Lombardia
Query!
Country [225]
0
0
Italy
Query!
State/province [225]
0
0
Marche
Query!
Country [226]
0
0
Italy
Query!
State/province [226]
0
0
Piemonte
Query!
Country [227]
0
0
Italy
Query!
State/province [227]
0
0
Puglia
Query!
Country [228]
0
0
Italy
Query!
State/province [228]
0
0
Toscana
Query!
Country [229]
0
0
Italy
Query!
State/province [229]
0
0
Trentino-Alto Adige
Query!
Country [230]
0
0
Italy
Query!
State/province [230]
0
0
Umbria
Query!
Country [231]
0
0
Italy
Query!
State/province [231]
0
0
Veneto
Query!
Country [232]
0
0
Japan
Query!
State/province [232]
0
0
Aichi
Query!
Country [233]
0
0
Japan
Query!
State/province [233]
0
0
Chiba
Query!
Country [234]
0
0
Japan
Query!
State/province [234]
0
0
Ehime
Query!
Country [235]
0
0
Japan
Query!
State/province [235]
0
0
Fukuoka
Query!
Country [236]
0
0
Japan
Query!
State/province [236]
0
0
Gunma
Query!
Country [237]
0
0
Japan
Query!
State/province [237]
0
0
Hiroshima
Query!
Country [238]
0
0
Japan
Query!
State/province [238]
0
0
Iwate
Query!
Country [239]
0
0
Japan
Query!
State/province [239]
0
0
Kagoshima
Query!
Country [240]
0
0
Japan
Query!
State/province [240]
0
0
Kanagawa
Query!
Country [241]
0
0
Japan
Query!
State/province [241]
0
0
Kumamoto
Query!
Country [242]
0
0
Japan
Query!
State/province [242]
0
0
Kyoto
Query!
Country [243]
0
0
Japan
Query!
State/province [243]
0
0
Niigata
Query!
Country [244]
0
0
Japan
Query!
State/province [244]
0
0
Osaka
Query!
Country [245]
0
0
Japan
Query!
State/province [245]
0
0
Saitama
Query!
Country [246]
0
0
Japan
Query!
State/province [246]
0
0
Shizuoka
Query!
Country [247]
0
0
Japan
Query!
State/province [247]
0
0
Tochigi
Query!
Country [248]
0
0
Japan
Query!
State/province [248]
0
0
Tokyo
Query!
Country [249]
0
0
Korea, Republic of
Query!
State/province [249]
0
0
Seongnam-si
Query!
Country [250]
0
0
Korea, Republic of
Query!
State/province [250]
0
0
Seoul
Query!
Country [251]
0
0
Mexico
Query!
State/province [251]
0
0
Campeche
Query!
Country [252]
0
0
Mexico
Query!
State/province [252]
0
0
Guanajuato
Query!
Country [253]
0
0
Mexico
Query!
State/province [253]
0
0
Jalisco
Query!
Country [254]
0
0
Mexico
Query!
State/province [254]
0
0
Mexico CITY (federal District)
Query!
Country [255]
0
0
Mexico
Query!
State/province [255]
0
0
Nuevo LEON
Query!
Country [256]
0
0
Mexico
Query!
State/province [256]
0
0
Oaxaca
Query!
Country [257]
0
0
Mexico
Query!
State/province [257]
0
0
Queretaro
Query!
Country [258]
0
0
Mexico
Query!
State/province [258]
0
0
Aguascalientes
Query!
Country [259]
0
0
Mexico
Query!
State/province [259]
0
0
Durango
Query!
Country [260]
0
0
Mexico
Query!
State/province [260]
0
0
San Luis Potosi
Query!
Country [261]
0
0
Netherlands
Query!
State/province [261]
0
0
Alkmaar
Query!
Country [262]
0
0
Netherlands
Query!
State/province [262]
0
0
Breda
Query!
Country [263]
0
0
Netherlands
Query!
State/province [263]
0
0
Delft
Query!
Country [264]
0
0
Netherlands
Query!
State/province [264]
0
0
Maastricht
Query!
Country [265]
0
0
Netherlands
Query!
State/province [265]
0
0
Zwolle
Query!
Country [266]
0
0
New Zealand
Query!
State/province [266]
0
0
Hamilton
Query!
Country [267]
0
0
New Zealand
Query!
State/province [267]
0
0
Palmerston North
Query!
Country [268]
0
0
Panama
Query!
State/province [268]
0
0
Panama
Query!
Country [269]
0
0
Peru
Query!
State/province [269]
0
0
Lima
Query!
Country [270]
0
0
Peru
Query!
State/province [270]
0
0
San Isidro
Query!
Country [271]
0
0
Peru
Query!
State/province [271]
0
0
Trujillo
Query!
Country [272]
0
0
Philippines
Query!
State/province [272]
0
0
Manila
Query!
Country [273]
0
0
Philippines
Query!
State/province [273]
0
0
Pasig City
Query!
Country [274]
0
0
Philippines
Query!
State/province [274]
0
0
Quezon City
Query!
Country [275]
0
0
Poland
Query!
State/province [275]
0
0
Bialystok
Query!
Country [276]
0
0
Poland
Query!
State/province [276]
0
0
Bydgoszcz
Query!
Country [277]
0
0
Poland
Query!
State/province [277]
0
0
Gdansk
Query!
Country [278]
0
0
Poland
Query!
State/province [278]
0
0
Opole
Query!
Country [279]
0
0
Poland
Query!
State/province [279]
0
0
Warszawa
Query!
Country [280]
0
0
Poland
Query!
State/province [280]
0
0
Wieliszew
Query!
Country [281]
0
0
Romania
Query!
State/province [281]
0
0
Bucharest
Query!
Country [282]
0
0
Romania
Query!
State/province [282]
0
0
Cluj Napoca
Query!
Country [283]
0
0
Romania
Query!
State/province [283]
0
0
Cluj-Napoca
Query!
Country [284]
0
0
Romania
Query!
State/province [284]
0
0
Iasi
Query!
Country [285]
0
0
Russian Federation
Query!
State/province [285]
0
0
Moskovskaja Oblast
Query!
Country [286]
0
0
Russian Federation
Query!
State/province [286]
0
0
Stavropol
Query!
Country [287]
0
0
Russian Federation
Query!
State/province [287]
0
0
Tatarstan
Query!
Country [288]
0
0
Russian Federation
Query!
State/province [288]
0
0
Samara
Query!
Country [289]
0
0
Russian Federation
Query!
State/province [289]
0
0
Tula
Query!
Country [290]
0
0
Slovenia
Query!
State/province [290]
0
0
Ljubljana
Query!
Country [291]
0
0
South Africa
Query!
State/province [291]
0
0
Bloemfontein
Query!
Country [292]
0
0
South Africa
Query!
State/province [292]
0
0
Johannesburg
Query!
Country [293]
0
0
South Africa
Query!
State/province [293]
0
0
Pretoria
Query!
Country [294]
0
0
Spain
Query!
State/province [294]
0
0
Alicante
Query!
Country [295]
0
0
Spain
Query!
State/province [295]
0
0
Barcelona
Query!
Country [296]
0
0
Spain
Query!
State/province [296]
0
0
Cantabria
Query!
Country [297]
0
0
Spain
Query!
State/province [297]
0
0
Castellon
Query!
Country [298]
0
0
Spain
Query!
State/province [298]
0
0
Cordoba
Query!
Country [299]
0
0
Spain
Query!
State/province [299]
0
0
Guipuzcoa
Query!
Country [300]
0
0
Spain
Query!
State/province [300]
0
0
Islas Baleares
Query!
Country [301]
0
0
Spain
Query!
State/province [301]
0
0
LA Coruña
Query!
Country [302]
0
0
Spain
Query!
State/province [302]
0
0
Tenerife
Query!
Country [303]
0
0
Spain
Query!
State/province [303]
0
0
Huelva
Query!
Country [304]
0
0
Spain
Query!
State/province [304]
0
0
Jaen
Query!
Country [305]
0
0
Spain
Query!
State/province [305]
0
0
La Coruña
Query!
Country [306]
0
0
Spain
Query!
State/province [306]
0
0
Lerida
Query!
Country [307]
0
0
Spain
Query!
State/province [307]
0
0
Madrid
Query!
Country [308]
0
0
Spain
Query!
State/province [308]
0
0
Malaga
Query!
Country [309]
0
0
Spain
Query!
State/province [309]
0
0
Murcia
Query!
Country [310]
0
0
Spain
Query!
State/province [310]
0
0
Salamanca
Query!
Country [311]
0
0
Spain
Query!
State/province [311]
0
0
Sevilla
Query!
Country [312]
0
0
Spain
Query!
State/province [312]
0
0
Toledo
Query!
Country [313]
0
0
Spain
Query!
State/province [313]
0
0
Valencia
Query!
Country [314]
0
0
Spain
Query!
State/province [314]
0
0
Zaragoza
Query!
Country [315]
0
0
Sweden
Query!
State/province [315]
0
0
Gothenburg
Query!
Country [316]
0
0
Sweden
Query!
State/province [316]
0
0
Linköping
Query!
Country [317]
0
0
Sweden
Query!
State/province [317]
0
0
Stockholm
Query!
Country [318]
0
0
Sweden
Query!
State/province [318]
0
0
Umea
Query!
Country [319]
0
0
Sweden
Query!
State/province [319]
0
0
Uppsala
Query!
Country [320]
0
0
Switzerland
Query!
State/province [320]
0
0
Basel
Query!
Country [321]
0
0
Switzerland
Query!
State/province [321]
0
0
Genève 14
Query!
Country [322]
0
0
Switzerland
Query!
State/province [322]
0
0
Luzern
Query!
Country [323]
0
0
Switzerland
Query!
State/province [323]
0
0
St. Gallen
Query!
Country [324]
0
0
Switzerland
Query!
State/province [324]
0
0
Zürich
Query!
Country [325]
0
0
Taiwan
Query!
State/province [325]
0
0
Changhua
Query!
Country [326]
0
0
Taiwan
Query!
State/province [326]
0
0
Kaohsiung
Query!
Country [327]
0
0
Taiwan
Query!
State/province [327]
0
0
Taichung
Query!
Country [328]
0
0
Taiwan
Query!
State/province [328]
0
0
Tainan
Query!
Country [329]
0
0
Taiwan
Query!
State/province [329]
0
0
Taipei
Query!
Country [330]
0
0
Thailand
Query!
State/province [330]
0
0
Chiang Rai
Query!
Country [331]
0
0
Thailand
Query!
State/province [331]
0
0
Lopburi
Query!
Country [332]
0
0
Thailand
Query!
State/province [332]
0
0
Phitsanuok
Query!
Country [333]
0
0
Thailand
Query!
State/province [333]
0
0
Songkla
Query!
Country [334]
0
0
Thailand
Query!
State/province [334]
0
0
Surat Thani
Query!
Country [335]
0
0
Ukraine
Query!
State/province [335]
0
0
Cherkassy
Query!
Country [336]
0
0
Ukraine
Query!
State/province [336]
0
0
Dnipropetrovsk
Query!
Country [337]
0
0
Ukraine
Query!
State/province [337]
0
0
Ivano-Frankivsk
Query!
Country [338]
0
0
Ukraine
Query!
State/province [338]
0
0
Kiev
Query!
Country [339]
0
0
Ukraine
Query!
State/province [339]
0
0
Lutsk
Query!
Country [340]
0
0
Ukraine
Query!
State/province [340]
0
0
Lvov
Query!
Country [341]
0
0
Ukraine
Query!
State/province [341]
0
0
Ternopil
Query!
Country [342]
0
0
United Kingdom
Query!
State/province [342]
0
0
Berkshire
Query!
Country [343]
0
0
United Kingdom
Query!
State/province [343]
0
0
Cardiff
Query!
Country [344]
0
0
United Kingdom
Query!
State/province [344]
0
0
Cheltenham
Query!
Country [345]
0
0
United Kingdom
Query!
State/province [345]
0
0
Colchester, Essex
Query!
Country [346]
0
0
United Kingdom
Query!
State/province [346]
0
0
Cornwall
Query!
Country [347]
0
0
United Kingdom
Query!
State/province [347]
0
0
Coventry
Query!
Country [348]
0
0
United Kingdom
Query!
State/province [348]
0
0
Edinburgh
Query!
Country [349]
0
0
United Kingdom
Query!
State/province [349]
0
0
Exeter
Query!
Country [350]
0
0
United Kingdom
Query!
State/province [350]
0
0
Ipswich
Query!
Country [351]
0
0
United Kingdom
Query!
State/province [351]
0
0
Leeds
Query!
Country [352]
0
0
United Kingdom
Query!
State/province [352]
0
0
London
Query!
Country [353]
0
0
United Kingdom
Query!
State/province [353]
0
0
Manchester
Query!
Country [354]
0
0
United Kingdom
Query!
State/province [354]
0
0
Northwood
Query!
Country [355]
0
0
United Kingdom
Query!
State/province [355]
0
0
Nottingham
Query!
Country [356]
0
0
United Kingdom
Query!
State/province [356]
0
0
Oxford
Query!
Country [357]
0
0
United Kingdom
Query!
State/province [357]
0
0
Peterborough
Query!
Country [358]
0
0
United Kingdom
Query!
State/province [358]
0
0
Portsmouth
Query!
Country [359]
0
0
United Kingdom
Query!
State/province [359]
0
0
Preston
Query!
Country [360]
0
0
United Kingdom
Query!
State/province [360]
0
0
Sheffield
Query!
Country [361]
0
0
United Kingdom
Query!
State/province [361]
0
0
Stoke-on-Trent
Query!
Country [362]
0
0
United Kingdom
Query!
State/province [362]
0
0
Sutton
Query!
Country [363]
0
0
United Kingdom
Query!
State/province [363]
0
0
Wirral
Query!
Country [364]
0
0
United Kingdom
Query!
State/province [364]
0
0
Wolverhampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Hoffmann-La Roche
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
Genentech, Inc.
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Other
Query!
Name [2]
0
0
Breast International Group
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG).
Query!
Trial website
https://clinicaltrials.gov/study/NCT01358877
Query!
Trial related presentations / publications
Gelber RD, Wang XV, Cole BF, Cameron D, Cardoso F, Tjan-Heijnen V, Krop I, Loi S, Salgado R, Kiermaier A, Frank E, Fumagalli D, Caballero C, de Azambuja E, Procter M, Clark E, Restuccia E, Heeson S, Bines J, Loibl S, Piccart-Gebhart M; APHINITY Steering Committee and Investigators. Six-year absolute invasive disease-free survival benefit of adding adjuvant pertuzumab to trastuzumab and chemotherapy for patients with early HER2-positive breast cancer: A Subpopulation Treatment Effect Pattern Plot (STEPP) analysis of the APHINITY (BIG 4-11) trial. Eur J Cancer. 2022 May;166:219-228. doi: 10.1016/j.ejca.2022.01.031. Epub 2022 Mar 18. Bines J, Clark E, Barton C, Restuccia E, Procter M, Sonnenblick A, Fumagalli D, Parlier D, Arahmani A, Baselga J, Viale G, Reaby LL, Frank E, Gelber RD, Piccart M, Jackisch C, Petersen JA. Patient-reported function, health-related quality of life, and symptoms in APHINITY: pertuzumab plus trastuzumab and chemotherapy in HER2-positive early breast cancer. Br J Cancer. 2021 Jul;125(1):38-47. doi: 10.1038/s41416-021-01323-y. Epub 2021 Apr 7. Piccart M, Procter M, Fumagalli D, de Azambuja E, Clark E, Ewer MS, Restuccia E, Jerusalem G, Dent S, Reaby L, Bonnefoi H, Krop I, Liu TW, Pienkowski T, Toi M, Wilcken N, Andersson M, Im YH, Tseng LM, Lueck HJ, Colleoni M, Monturus E, Sicoe M, Guillaume S, Bines J, Gelber RD, Viale G, Thomssen C; APHINITY Steering Committee and Investigators. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years' Follow-Up. J Clin Oncol. 2021 May 1;39(13):1448-1457. doi: 10.1200/JCO.20.01204. Epub 2021 Feb 4. Bines J, Procter M, Restuccia E, Viale G, Zardavas D, Suter T, Arahmani A, Van Dooren V, Baselga J, Clark E, Eng-Wong J, Gelber RD, Piccart M, Mobus V, de Azambuja E; APHINITY Steering Committee and Investigators. Incidence and Management of Diarrhea With Adjuvant Pertuzumab and Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer. Clin Breast Cancer. 2020 Apr;20(2):174-181.e3. doi: 10.1016/j.clbc.2019.06.016. Epub 2019 Sep 5. Luo Y, Li W, Jiang Z, Zhang Q, Wang L, Mao Y, Tjan-Heijnen VCG, Im SA, McConnell R, Bejarano S, Fumagalli D, Bines J, Wang B, Garg A, Kirschbrown WP, Xu B. Pharmacokinetics of pertuzumab administered concurrently with trastuzumab in Chinese patients with HER2-positive early breast cancer. Anticancer Drugs. 2019 Sep;30(8):866-872. doi: 10.1097/CAD.0000000000000808. Kirschbrown WP, Kagedal M, Wang B, Lindbom L, Knott A, Mack R, Monemi S, Nijem I, Girish S, Freeman C, Fumagalli D, McConnell R, Jerusalem G, Twelves C, Baselga J, von Minckwitz G, Bines J, Garg A. Pharmacokinetic and exploratory exposure-response analysis of pertuzumab in patients with operable HER2-positive early breast cancer in the APHINITY study. Cancer Chemother Pharmacol. 2019 Jun;83(6):1147-1158. doi: 10.1007/s00280-019-03826-1. Epub 2019 Apr 11. von Minckwitz G, Procter M, de Azambuja E, Zardavas D, Benyunes M, Viale G, Suter T, Arahmani A, Rouchet N, Clark E, Knott A, Lang I, Levy C, Yardley DA, Bines J, Gelber RD, Piccart M, Baselga J; APHINITY Steering Committee and Investigators. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer. N Engl J Med. 2017 Jul 13;377(2):122-131. doi: 10.1056/NEJMoa1703643. Epub 2017 Jun 5. Erratum In: N Engl J Med. 2017 Aug 17;377(7):702. doi: 10.1056/NEJMx170011. N Engl J Med. 2018 Oct 18;379(16):1585.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Trials
Query!
Address
0
0
Hoffmann-La Roche
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01358877
Download to PDF