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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/NCT01120184
Registration number
NCT01120184
Ethics application status
Date submitted
28/04/2010
Date registered
10/05/2010
Date last updated
4/03/2024
Titles & IDs
Public title
A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)
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Scientific title
A Randomized, 3 Arm, Multicenter, Phase III Study to Evaluate the Efficacy and the Safety of T-DM1 Combined With Pertuzumab or T-DM1 Combined With Pertuzumab-Placebo (Blinded for Pertuzumab), Versus the Combination of Trastuzumab Plus Taxane, as First Line Treatment in HER2 Positive Progressive or Recurrent Locally Advanced or Metastatic Breast Cancer
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Secondary ID [1]
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2009-017905-13
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Secondary ID [2]
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BO22589
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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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 - paclitaxel
Treatment: Drugs - pertuzumab
Treatment: Drugs - pertuzumab-placebo
Treatment: Drugs - trastuzumab [Herceptin]
Treatment: Drugs - trastuzumab emtansine
Experimental: Trastuzumab + Taxane (docetaxel or paclitaxel) -
Experimental: Trastuzumab emtansine + pertuzumab -
Experimental: Trastuzumab emtansine + pertuzumab placebo -
Treatment: Drugs: docetaxel
75 mg/m2 or 100 mg/m2 intravenously every 3 weeks for a minimum of 6 cycles.
Treatment: Drugs: paclitaxel
80 mg/m2 intravenously weekly for a minimum of 18 weeks
Treatment: Drugs: pertuzumab
840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles
Treatment: Drugs: pertuzumab-placebo
840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles
Treatment: Drugs: trastuzumab [Herceptin]
trastuzumab [Herceptin] doses when administered with docetaxel: 8 mg/kg intravenously on cycle 1 followed by 6 mg/kg every 3 weeks in subsequent cycles or trastuzumab (Herceptin) doses when administered with paclitaxel: 4 mg/kg intravenously on day 1 of cycle 1 followed by 2 mg/kg weekly starting on day 8 of cycle 1.
Treatment: Drugs: trastuzumab emtansine
3.6 mg/kg intravenously every 3 weeks
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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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Percentage of Participants With Death or Disease Progression According to Independent Review Facility (IRF) Assessment
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Assessment method [1]
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Tumor assessments were performed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a greater than or equal to (=) 20 percent (%) and 5-millimeter (mm) increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.
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Timepoint [1]
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Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
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Primary outcome [2]
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Progression-Free Survival (PFS) According to IRF Assessment
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Assessment method [2]
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Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a =20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis, and corresponding confidence intervals (CIs) were computed using the Brookmeyer-Crowley method.
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Timepoint [2]
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Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
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Secondary outcome [1]
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Percentage of Participants Who Died Prior to Clinical Cutoff
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Assessment method [1]
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The percentage of participants who died prior to clinical cutoff was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.
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Timepoint [1]
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Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)
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Secondary outcome [2]
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Overall Survival (OS) at Clinical Cutoff
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Assessment method [2]
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OS was defined as the time from randomization to death from any cause. Median duration of OS was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.
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Timepoint [2]
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Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)
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Secondary outcome [3]
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Percentage of Participants With Death or Disease Progression According to Investigator Assessment
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Assessment method [3]
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Tumor assessments were performed by the investigator according to RECIST version 1.1. Disease progression was defined as a =20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.
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Timepoint [3]
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Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
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Secondary outcome [4]
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PFS According to Investigator Assessment
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Assessment method [4]
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Tumor assessments were performed by the investigator according to RECIST version 1.1. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a =20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.
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Timepoint [4]
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Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
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Secondary outcome [5]
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Percentage of Participants Experiencing Treatment Failure
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Assessment method [5]
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Treatment failure was defined as the discontinuation of all study medications in the treatment arm for any reason including disease progression, treatment toxicity, death, physician decision, or participant withdrawal. The percentage of participants with treatment failure was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.
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Timepoint [5]
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Up to 48 months from randomization until clinical cutoff of 16-Sept-2014
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Secondary outcome [6]
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Time to Treatment Failure (TTF)
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Assessment method [6]
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Treatment failure was defined as the discontinuation of all study medications in the treatment arm for any reason including disease progression, treatment toxicity, death, physician decision, or participant withdrawal. TTF was defined as the time from randomization to treatment failure. Median TTF was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.
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Timepoint [6]
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Up to 48 months from randomization until clinical cutoff of 16-Sept-2014
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Secondary outcome [7]
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One-Year Survival Rate
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Assessment method [7]
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The percentage of participants alive at 1 year after randomization was estimated as the one-year survival rate using Kaplan-Meier analysis, and corresponding CIs were computed using Greenwood's estimate of the standard error.
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Timepoint [7]
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From randomization until 1 year
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Secondary outcome [8]
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Percentage of Participants With Grade =3 Adverse Events
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Assessment method [8]
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Adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activity of daily living with inability to perform bathing, dressing and undressing, feeding self, using the toilet, taking medications but not bedridden. Grade 4: An immediate threat to life. Urgent medical intervention is required in order to maintain survival. Grade 5: Death.
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Timepoint [8]
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Up to 50 months from randomization until clinical cutoff of 16-Sept-2014 (continuously until 28 days after last dose
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Secondary outcome [9]
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Percentage of Participants Who Died at 2 Years
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Assessment method [9]
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Timepoint [9]
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From randomization until 2 years
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Secondary outcome [10]
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Overall Survival Truncated at 2 Years
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Assessment method [10]
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Overall Survival truncated at 2 years was defined as the percentage of participants alive at 2 years.
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Timepoint [10]
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From randomization until 2 years
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Secondary outcome [11]
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Percentage of Participants With Grade 5 Adverse Events
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Assessment method [11]
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Adverse events were graded according to NCI CTCAE version 4.0. Grade 5 adverse events are those events which led to death.
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Timepoint [11]
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Up to 50 months from randomization until clinical cutoff of 16-Sept-2014 (continuously until 28 days after last dose)
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Secondary outcome [12]
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Percentage of Participants With Grade 3-4 Laboratory Parameters
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Assessment method [12]
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Laboratory results were graded according to NCI CTCAE version 4.0. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activity of daily living with inability to perform bathing, dressing and undressing, feeding self, using the toilet, taking medications but not bedridden. Grade 4: An immediate threat to life. Urgent medical intervention is required in order to maintain survival.
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Timepoint [12]
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Day 1, 8, and 15 of Cycle 1-3 and on Day 1 of each subsequent cycle up to 50 months from randomization until clinical cutoff of 16-Sept-2014
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Secondary outcome [13]
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Percentage of Participants With Decline of =2 Points From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
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Assessment method [13]
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The ECOG performance status is a scale used to quantify cancer participants' general well-being and activities of daily life. The scale ranges from 0 to 5, with 0 denoting perfect health and 5 indicating death. The 6 categories are 0=Asymptomatic (Fully active, able to carry on all predisease activities without restriction), 1=Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2=Symptomatic, < 50% in bed during the day (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours), 3=Symptomatic, > 50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours), 4=Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair), 5=Death.
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Timepoint [13]
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Baseline, Day 1 of every Cycle up to Clinical Data Cut (up to 48 months)
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Secondary outcome [14]
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Hospitalization Days
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Assessment method [14]
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Hospitalization was defined as a non-administration-related hospitalization due to serious adverse event, while on study treatment. Reported values represent number of days admitted per participants.
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Timepoint [14]
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Up to 48 months from randomization until clinical cutoff of 16-Sept-2014
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Secondary outcome [15]
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Percentage of Participants With Hospitalization
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Assessment method [15]
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Hospitalization was defined as a non-administration-related hospitalization due to serious adverse event, while on study treatment.
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Timepoint [15]
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Up to 48 months from randomization until clinical cutoff of 16-Sept-2014
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Secondary outcome [16]
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Percentage of Participants With Objective Response According to IRF Assessment
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Assessment method [16]
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Objective response was defined as having complete response (CR) or partial response (PR), assessed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a =30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the objective response rate [ORR]) was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100. Corresponding CIs were computed using the Blyth-Still-Casella exact method.
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Timepoint [16]
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Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
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Secondary outcome [17]
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Percentage of Participants With Objective Response According to Investigator Assessment
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Assessment method [17]
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Objective response was defined as having CR or PR, assessed according to RECIST version 1.1, by investigator. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a =30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the ORR) was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100. Corresponding CIs were computed using the Blyth-Still-Casella exact method.
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Timepoint [17]
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Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
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Secondary outcome [18]
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Duration of Response According to IRF Assessment
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Assessment method [18]
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Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Duration of response was defined as the time from confirmed PR or CR to first documented disease progression or death from any cause. CR was defined as the disappearance of all target lesions and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a =30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. Median duration of response was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.
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Timepoint [18]
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Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
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Secondary outcome [19]
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Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD) According to IRF Assessment
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Assessment method [19]
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Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a =30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient (20%) increase to qualify for disease progression. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR, PR, or SD was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100.
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Timepoint [19]
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Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
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Secondary outcome [20]
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Percentage of Participants Experiencing a Clinically Significant Increase in Taxane-Related Treatment Symptoms as Measured by Taxane Subscale of the Functional Assessment of Cancer Therapy (FACT) Taxane (FACT-TaxS) Score
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Assessment method [20]
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The FACT-Taxane is a self-reported instrument which measures the health-related quality of life (HRQOL) of participants receiving taxane-containing chemotherapy. The FACT-TaxS consists of 16 items including 11 neurotoxicity-related questions and 5 additional questions assessing arthralgia, myalgia, and skin discoloration. Items are rated from 0 (not at all) to 4 (very much) and a total score is inversely derived. Scores may range from 0 to 64, with higher scores indicating fewer/no symptoms. A minimally clinically important difference in treatment-related symptoms was defined as a =5% decrease (ie, 3.2 points) in FACT-TaxS score from Baseline. The percentage of participants with treatment-related symptoms was calculated using following formula: [number of participants meeting the above threshold divided by the number analyzed] multiplied by 100. Corresponding CIs were computed using the Blyth-Still-Casella exact method.
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Timepoint [20]
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Up to 39 months from randomization until clinical cutoff of 16-Sept-2014 (at Baseline, on Day 1 of Cycles 2 to 8 and every even-numbered cycle thereafter and/or up to 42 days after last dose)
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Secondary outcome [21]
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Percentage of Participants Reporting Nausea According to the Relevant Single Items of The FACT Colorectal Cancel (FACT-C) Module
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Assessment method [21]
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The FACT-C is a self-reported instrument which measures HRQOL pertaining to colorectal cancer. Response options on each question may range from 0 (not at all) to 4 (very much). The percentage of participants with nausea was calculated using following formula: [number of participants with any level of either symptom divided by the number analyzed] multiplied by 100.
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Timepoint [21]
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At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2
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Secondary outcome [22]
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Percentage of Participants Reporting Diarrhea According to the Relevant Single Items of The FACT-C Module
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Assessment method [22]
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The FACT-C is a self-reported instrument which measures HRQOL pertaining to colorectal cancer. Response options on each question may range from 0 (not at all) to 4 (very much). The percentage of participants with diarrhea was calculated using following formula: [number of participants with any level of either symptom divided by the number analyzed] multiplied by 100.
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Timepoint [22]
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At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2
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Secondary outcome [23]
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Percentage of Participants With a Clinically Significant Deterioration in Health Related Quality of Life (HRQoL) as Measured by FACT Breast (FACT-B) Trial Outcome Index-Physical Function Breast (TOI-PFB) Score
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Assessment method [23]
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The FACT-B is a self-reported instrument which measures HRQOL of participants with breast cancer. It consists of 5 subscales including physical well-being (PWB), social well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and a breast cancer subscale (BCS). The TOI-PFB score is taken by adding the scores from the PWB (7 items), FWB (7 items), and BCS (9 items) subscales. Items are rated from 0 (not at all) to 4 (very much) and a total score is derived. Scores may range from 0 to 92, with higher scores indicating better HRQOL. A 5 point change has been identified as the clinically minimal important difference (CMID) on the FACT-TOI-PFB scale. The percentage of participants with deterioration was calculated as [number of participants meeting the above threshold divided by the number analyzed] multiplied by 100.
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Timepoint [23]
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Up to 39 months from randomization until clinical cutoff of 16-Sept-2014 (at Baseline, on Day 1 of Cycles 2 to 8 and every even-numbered cycle thereafter and/or up to 42 days after last dose)
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Secondary outcome [24]
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Time to Deterioration in HRQoL as Assessed by FACT-B TOI-PFB Score
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Assessment method [24]
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The FACT-B is a self-reported instrument which measures HRQOL of participants with breast cancer. It consists of 5 subscales including PWB, SWB, EWB, FWB, and BCS. The TOI-PFB score is taken by adding the scores from the PWB (7 items), FWB (7 items), and BCS (9 items) subscales. Items are rated from 0 (not at all) to 4 (very much) and a total score is derived. Scores may range from 0 to 92, with higher scores indicating better HRQOL. A 5 point change has been identified as the clinically minimal important difference (CMID) on the FACT-TOI-PFB scale. Time to deterioration was defined as the time from Baseline until the first decrease in FACT-B TOI-PFB score. Median time to deterioration was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.
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Timepoint [24]
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Baseline up to 39 months from randomization until clinical cutoff of 16-Sept-2014
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Secondary outcome [25]
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0
Change From Baseline in Rotterdam Symptom Checklist (RSCL) Activity Level Scale Score
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Assessment method [25]
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The RSCL is a self-reported instrument which consists of 4 domains including physical symptom distress, psychological distress, activity level, and overall global life quality. Only the activity level scale was collected and assessed. Scores may range from 0 to 100, with higher scores indicating increased burden of disease. Mean RSCL activity scale score changes were calculated as [mean score at the assessment visit minus mean score at Baseline]. The higher the score, the higher the level of impairment or burden.
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Timepoint [25]
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Baseline, Cycle 7 (Week 18)
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Secondary outcome [26]
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Change From Baseline in Work Productivity According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score
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Assessment method [26]
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The WPAI is a patient-reported measure which assesses the effect of general health and symptom severity on work productivity and regular activities. The General Health questionnaire asks participants to estimate the number of hours missed from work due to reasons related and unrelated to their health problems, as well as the total number of hours actually worked in the preceding 7-day period. The percentage of participants reporting that they were employed (working for pay) was assessed at baseline was assessed along with Absenteeism (work time missed), Presenteeism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. The reported changes represent change from baseline at Cycle 7. The score range for the scales of the WPAI is between 0 (no effect) to 100% (max effect)
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Timepoint [26]
0
0
Baseline, Cycle 7 (Week 18)
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Secondary outcome [27]
0
0
Change From Baseline in Activity Impairment According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score
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Assessment method [27]
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0
The WPAI is a patient-reported measure which assesses the effect of general health and symptom severity on work productivity and regular activities. The General Health questionnaire asks participants to estimate the number of hours missed from work due to reasons related and unrelated to their health problems, as well as the total number of hours actually worked in the preceding 7-day period. The percentage of participants reporting that they were employed (working for pay) was assessed at baseline was assessed along with Absenteeism (work time missed), Presenteeism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. The reported changes represent change from baseline at Cycle 7. The score range for the scales of the WPAI is between 0 (no effect) to 100% (max effect).
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Timepoint [27]
0
0
Baseline, Cycle 7 (Week 18)
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Secondary outcome [28]
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Percentage of Participants With a Best Overall Response of CR or PR According to IRF Assessment Among Those With High Human Epidermal Growth Factor Receptor 2 (HER2) Messenger Ribonucleic Acid (mRNA) Levels
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Assessment method [28]
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0
Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a =30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the ORR) was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100.
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Timepoint [28]
0
0
Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
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Secondary outcome [29]
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0
Percentage of Participants With a Best Overall Response of CR or PR According to IRF Assessment Among Those With Low HER2 mRNA Levels
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Assessment method [29]
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0
Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a =30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the ORR) was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100.
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Timepoint [29]
0
0
Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
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Secondary outcome [30]
0
0
Percentage of Participants With Death or Disease Progression According to IRF Assessment Among Those With High HER2 mRNA Levels
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Assessment method [30]
0
0
Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a =20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.
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Timepoint [30]
0
0
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
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Secondary outcome [31]
0
0
PFS According to IRF Assessment Among Those With High HER2 mRNA Levels
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Assessment method [31]
0
0
Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a =20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis.
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Timepoint [31]
0
0
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
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Secondary outcome [32]
0
0
Percentage of Participants With Death or Disease Progression According to IRF Assessment Among Those With Low HER2 mRNA Levels
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Assessment method [32]
0
0
Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a =20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.
Query!
Timepoint [32]
0
0
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
Query!
Secondary outcome [33]
0
0
PFS According to IRF Assessment Among Those With Low HER2 mRNA Levels
Query!
Assessment method [33]
0
0
Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a =20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis.
Query!
Timepoint [33]
0
0
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
Query!
Secondary outcome [34]
0
0
Percentage of Participants Who Died Prior to Clinical Cutoff Among Those With High HER2 mRNA Levels
Query!
Assessment method [34]
0
0
The percentage of participants who died prior to clinical cutoff was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.
Query!
Timepoint [34]
0
0
Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)
Query!
Secondary outcome [35]
0
0
OS at Clinical Cutoff Among Those With High HER2 mRNA Levels
Query!
Assessment method [35]
0
0
OS was defined as the time from randomization to death from any cause. Median duration of OS was estimated using Kaplan-Meier analysis.
Query!
Timepoint [35]
0
0
Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)
Query!
Secondary outcome [36]
0
0
Percentage of Participants Who Died Prior to Clinical Cutoff Among Those With Low HER2 mRNA Levels
Query!
Assessment method [36]
0
0
The percentage of participants who died prior to clinical cutoff was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.
Query!
Timepoint [36]
0
0
Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)
Query!
Secondary outcome [37]
0
0
OS at Clinical Cutoff Among Those With Low HER2 mRNA Levels
Query!
Assessment method [37]
0
0
OS was defined as the time from randomization to death from any cause. Median duration of OS was estimated using Kaplan-Meier analysis. Reported upper bound of confidence interval for "Trastuzumab Emtansine + Placebo" and confidence interval values for "Trastuzumab + Taxane" and "Trastuzumab Emtansine + Pertuzumab" are censored values.
Query!
Timepoint [37]
0
0
Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)
Query!
Eligibility
Key inclusion criteria
- Adult participants >/=18 years of age
- HER2-positive breast cancer
- Histologically or cytologically confirmed adenocarcinoma of the breast with locally
recurrent or metastatic disease, and be a candidate for chemotherapy. Participants
with locally advanced disease must have recurrent or progressive disease, which must
not be amenable to resection with curative intent.
- Participants must have measurable and/or non-measurable disease which must be
evaluable per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Adequate organ function as determined by laboratory results
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 prior (or any) chemotherapy for metastatic breast cancer or recurrent
locally advanced disease
- An interval of <6 months from the last dose of vinca-alkaloid or taxane cytotoxic
chemotherapy until the time of metastatic diagnosis
- Hormone therapy <7 days prior to randomization
- Trastuzumab therapy and/or lapatinib (neo- or adjuvant setting) <21 days prior to
randomization
- Prior trastuzumab emtansine or pertuzumab therapy
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 assessing the outcomes
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
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
31/07/2010
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
16/09/2016
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1095
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
Mater Misericordiae Hospital; Chemotherapy Cottage - Sydney
Query!
Recruitment hospital [2]
0
0
Calvary Mater Newcastle; Medical Oncology - Waratah
Query!
Recruitment hospital [3]
0
0
Wesley Medical Centre; Clinic For Haematology and Oncology - Auchenflower
Query!
Recruitment hospital [4]
0
0
Royal Adelaide Hospital; Oncology - Adelaide
Query!
Recruitment hospital [5]
0
0
Peter Maccallum Cancer Institute; Medical Oncology - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2060 - Sydney
Query!
Recruitment postcode(s) [2]
0
0
2298 - Waratah
Query!
Recruitment postcode(s) [3]
0
0
4066 - Auchenflower
Query!
Recruitment postcode(s) [4]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [5]
0
0
3000 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arkansas
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
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Hawaii
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Idaho
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Indiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kentucky
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Maine
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Maryland
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Massachusetts
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Michigan
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Minnesota
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Missouri
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New Hampshire
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New Jersey
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New Mexico
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
New York
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
North Carolina
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
North Dakota
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Ohio
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Pennsylvania
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
South Carolina
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
South Dakota
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Tennessee
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Texas
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Utah
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Washington
Query!
Country [31]
0
0
Argentina
Query!
State/province [31]
0
0
Buenos Aires
Query!
Country [32]
0
0
Argentina
Query!
State/province [32]
0
0
San Miguel de Tucuman
Query!
Country [33]
0
0
Austria
Query!
State/province [33]
0
0
Salzburg
Query!
Country [34]
0
0
Austria
Query!
State/province [34]
0
0
Wien
Query!
Country [35]
0
0
Bahamas
Query!
State/province [35]
0
0
Nassau
Query!
Country [36]
0
0
Belgium
Query!
State/province [36]
0
0
Bruxelles
Query!
Country [37]
0
0
Belgium
Query!
State/province [37]
0
0
Namur
Query!
Country [38]
0
0
Belgium
Query!
State/province [38]
0
0
Wilrijk
Query!
Country [39]
0
0
Bosnia and Herzegovina
Query!
State/province [39]
0
0
Banja Luka
Query!
Country [40]
0
0
Bosnia and Herzegovina
Query!
State/province [40]
0
0
Sarajevo
Query!
Country [41]
0
0
Brazil
Query!
State/province [41]
0
0
RJ
Query!
Country [42]
0
0
Brazil
Query!
State/province [42]
0
0
RN
Query!
Country [43]
0
0
Brazil
Query!
State/province [43]
0
0
RS
Query!
Country [44]
0
0
Brazil
Query!
State/province [44]
0
0
SC
Query!
Country [45]
0
0
Brazil
Query!
State/province [45]
0
0
SP
Query!
Country [46]
0
0
Canada
Query!
State/province [46]
0
0
Alberta
Query!
Country [47]
0
0
Canada
Query!
State/province [47]
0
0
Ontario
Query!
Country [48]
0
0
Canada
Query!
State/province [48]
0
0
Quebec
Query!
Country [49]
0
0
Colombia
Query!
State/province [49]
0
0
Bogota
Query!
Country [50]
0
0
Colombia
Query!
State/province [50]
0
0
Bucaramanga
Query!
Country [51]
0
0
Colombia
Query!
State/province [51]
0
0
Cali
Query!
Country [52]
0
0
Colombia
Query!
State/province [52]
0
0
Pasto
Query!
Country [53]
0
0
Czechia
Query!
State/province [53]
0
0
Brno
Query!
Country [54]
0
0
Czechia
Query!
State/province [54]
0
0
Olomouc
Query!
Country [55]
0
0
Czechia
Query!
State/province [55]
0
0
Praha 2
Query!
Country [56]
0
0
Czechia
Query!
State/province [56]
0
0
Praha
Query!
Country [57]
0
0
Denmark
Query!
State/province [57]
0
0
Vejle
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Besancon
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Clermont Ferrand
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Lille
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Marseille
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Montpellier
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Nancy
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
Paris
Query!
Country [65]
0
0
France
Query!
State/province [65]
0
0
Poitiers
Query!
Country [66]
0
0
France
Query!
State/province [66]
0
0
Saint Cloud
Query!
Country [67]
0
0
France
Query!
State/province [67]
0
0
St Priest En Jarez
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
Halle
Query!
Country [70]
0
0
Germany
Query!
State/province [70]
0
0
Hamburg
Query!
Country [71]
0
0
Germany
Query!
State/province [71]
0
0
Hannover
Query!
Country [72]
0
0
Germany
Query!
State/province [72]
0
0
Heidelberg
Query!
Country [73]
0
0
Germany
Query!
State/province [73]
0
0
Magdeburg
Query!
Country [74]
0
0
Germany
Query!
State/province [74]
0
0
Mainz
Query!
Country [75]
0
0
Germany
Query!
State/province [75]
0
0
Minden
Query!
Country [76]
0
0
Germany
Query!
State/province [76]
0
0
Muenchen
Query!
Country [77]
0
0
Germany
Query!
State/province [77]
0
0
Trier
Query!
Country [78]
0
0
Greece
Query!
State/province [78]
0
0
Athens
Query!
Country [79]
0
0
Greece
Query!
State/province [79]
0
0
Heraklion
Query!
Country [80]
0
0
Greece
Query!
State/province [80]
0
0
Larissa
Query!
Country [81]
0
0
Guatemala
Query!
State/province [81]
0
0
Guatemala City
Query!
Country [82]
0
0
Guatemala
Query!
State/province [82]
0
0
Guatemala
Query!
Country [83]
0
0
Hungary
Query!
State/province [83]
0
0
Budapest
Query!
Country [84]
0
0
Hungary
Query!
State/province [84]
0
0
Pécs
Query!
Country [85]
0
0
Italy
Query!
State/province [85]
0
0
Calabria
Query!
Country [86]
0
0
Italy
Query!
State/province [86]
0
0
Emilia-Romagna
Query!
Country [87]
0
0
Italy
Query!
State/province [87]
0
0
Friuli-Venezia Giulia
Query!
Country [88]
0
0
Italy
Query!
State/province [88]
0
0
Lombardia
Query!
Country [89]
0
0
Italy
Query!
State/province [89]
0
0
Sicilia
Query!
Country [90]
0
0
Italy
Query!
State/province [90]
0
0
Toscana
Query!
Country [91]
0
0
Italy
Query!
State/province [91]
0
0
Umbria
Query!
Country [92]
0
0
Japan
Query!
State/province [92]
0
0
Aichi
Query!
Country [93]
0
0
Japan
Query!
State/province [93]
0
0
Ehime
Query!
Country [94]
0
0
Japan
Query!
State/province [94]
0
0
Fukuoka
Query!
Country [95]
0
0
Japan
Query!
State/province [95]
0
0
Gifu
Query!
Country [96]
0
0
Japan
Query!
State/province [96]
0
0
Hiroshima
Query!
Country [97]
0
0
Japan
Query!
State/province [97]
0
0
Hokkaido
Query!
Country [98]
0
0
Japan
Query!
State/province [98]
0
0
Hyogo
Query!
Country [99]
0
0
Japan
Query!
State/province [99]
0
0
Ishikawa
Query!
Country [100]
0
0
Japan
Query!
State/province [100]
0
0
Iwate
Query!
Country [101]
0
0
Japan
Query!
State/province [101]
0
0
Kagoshima
Query!
Country [102]
0
0
Japan
Query!
State/province [102]
0
0
Kanagawa
Query!
Country [103]
0
0
Japan
Query!
State/province [103]
0
0
Kumamoto
Query!
Country [104]
0
0
Japan
Query!
State/province [104]
0
0
Kyoto
Query!
Country [105]
0
0
Japan
Query!
State/province [105]
0
0
Miyagi
Query!
Country [106]
0
0
Japan
Query!
State/province [106]
0
0
Niigata
Query!
Country [107]
0
0
Japan
Query!
State/province [107]
0
0
Okayama
Query!
Country [108]
0
0
Japan
Query!
State/province [108]
0
0
Osaka
Query!
Country [109]
0
0
Japan
Query!
State/province [109]
0
0
Saitama
Query!
Country [110]
0
0
Japan
Query!
State/province [110]
0
0
Shizuoka
Query!
Country [111]
0
0
Japan
Query!
State/province [111]
0
0
Tokyo
Query!
Country [112]
0
0
Korea, Republic of
Query!
State/province [112]
0
0
Gyeonggi-do
Query!
Country [113]
0
0
Korea, Republic of
Query!
State/province [113]
0
0
Seoul
Query!
Country [114]
0
0
Malaysia
Query!
State/province [114]
0
0
FED. Territory OF Kuala Lumpur
Query!
Country [115]
0
0
Malaysia
Query!
State/province [115]
0
0
Selangor
Query!
Country [116]
0
0
Mexico
Query!
State/province [116]
0
0
Guerrero
Query!
Country [117]
0
0
Mexico
Query!
State/province [117]
0
0
Nuevo LEON
Query!
Country [118]
0
0
Mexico
Query!
State/province [118]
0
0
Oaxaca
Query!
Country [119]
0
0
Mexico
Query!
State/province [119]
0
0
Sonora
Query!
Country [120]
0
0
Mexico
Query!
State/province [120]
0
0
Aguascalientes
Query!
Country [121]
0
0
Mexico
Query!
State/province [121]
0
0
Toluca
Query!
Country [122]
0
0
New Zealand
Query!
State/province [122]
0
0
Auckland
Query!
Country [123]
0
0
New Zealand
Query!
State/province [123]
0
0
Hamilton
Query!
Country [124]
0
0
North Macedonia
Query!
State/province [124]
0
0
Skopje
Query!
Country [125]
0
0
Panama
Query!
State/province [125]
0
0
Panama
Query!
Country [126]
0
0
Peru
Query!
State/province [126]
0
0
Arequipa
Query!
Country [127]
0
0
Peru
Query!
State/province [127]
0
0
Lima
Query!
Country [128]
0
0
Peru
Query!
State/province [128]
0
0
Piura
Query!
Country [129]
0
0
Philippines
Query!
State/province [129]
0
0
Cebu City
Query!
Country [130]
0
0
Philippines
Query!
State/province [130]
0
0
San Juan
Query!
Country [131]
0
0
Poland
Query!
State/province [131]
0
0
Bydgoszcz
Query!
Country [132]
0
0
Poland
Query!
State/province [132]
0
0
Gdansk
Query!
Country [133]
0
0
Poland
Query!
State/province [133]
0
0
Krakow
Query!
Country [134]
0
0
Poland
Query!
State/province [134]
0
0
Lublin
Query!
Country [135]
0
0
Poland
Query!
State/province [135]
0
0
Warszawa
Query!
Country [136]
0
0
Portugal
Query!
State/province [136]
0
0
Porto
Query!
Country [137]
0
0
Romania
Query!
State/province [137]
0
0
Bucharest
Query!
Country [138]
0
0
Romania
Query!
State/province [138]
0
0
Cluj Napoca
Query!
Country [139]
0
0
Romania
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State/province [139]
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0
Cluj-Napoca
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Country [140]
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0
Russian Federation
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State/province [140]
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0
Moskovskaja Oblast
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Country [141]
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Russian Federation
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State/province [141]
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0
Rjazan
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Country [142]
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Russian Federation
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State/province [142]
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Stavropol
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Country [143]
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Russian Federation
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State/province [143]
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0
Tatarstan
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Country [144]
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Russian Federation
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Ivanovo
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Country [145]
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Russian Federation
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State/province [145]
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Samara
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Country [146]
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Russian Federation
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Tula
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Country [147]
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Russian Federation
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Vladimir
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Country [148]
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0
Spain
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State/province [148]
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Alicante
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Country [149]
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0
Spain
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State/province [149]
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Barcelona
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Country [150]
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0
Spain
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State/province [150]
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LA Coruña
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Country [151]
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0
Spain
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State/province [151]
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Jaen
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Country [152]
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Spain
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State/province [152]
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La Coruña
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Country [153]
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Spain
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State/province [153]
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Madrid
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Country [154]
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Spain
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State/province [154]
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Malaga
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Country [155]
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Spain
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Valencia
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Country [156]
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Sweden
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State/province [156]
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Malmö
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Country [157]
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0
Switzerland
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State/province [157]
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Baden
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Country [158]
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0
Switzerland
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State/province [158]
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Basel
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Country [159]
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Switzerland
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State/province [159]
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Chur
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Country [160]
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Taiwan
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State/province [160]
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Changhua
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Country [161]
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Taiwan
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State/province [161]
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Kaohsiung
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Country [162]
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Taiwan
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Taipei
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Country [163]
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Thailand
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Bangkok
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Country [164]
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Thailand
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Chiang Mai
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Country [165]
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Thailand
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State/province [165]
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Songkhla
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Country [166]
0
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Turkey
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State/province [166]
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Adana
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Country [167]
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Turkey
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State/province [167]
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Ankara
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Country [168]
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Turkey
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State/province [168]
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Izmir
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Country [169]
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United Kingdom
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State/province [169]
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Bristol
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Country [170]
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United Kingdom
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State/province [170]
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Cambridge
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Country [171]
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United Kingdom
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State/province [171]
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Cornwall
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Country [172]
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United Kingdom
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Glasgow
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Country [173]
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United Kingdom
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Leicester
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Country [174]
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United Kingdom
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State/province [174]
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London
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Country [175]
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United Kingdom
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State/province [175]
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Manchester
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Country [176]
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United Kingdom
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State/province [176]
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Nottingham
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Country [177]
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United Kingdom
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State/province [177]
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Peterborough
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Country [178]
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United Kingdom
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State/province [178]
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Portsmouth
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Country [179]
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United Kingdom
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State/province [179]
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Sheffield
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Country [180]
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United Kingdom
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Southampton
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Country [181]
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United Kingdom
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Stoke-on-Trent
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Country [182]
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United Kingdom
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State/province [182]
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Sutton
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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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Other collaborator category [1]
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0
Commercial sector/Industry
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Name [1]
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Genentech, Inc.
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Address [1]
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0
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of
trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with
pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab
(Herceptin) plus taxane (docetaxel or paclitaxel) in participants with HER2-positive
progressive or recurrent locally advanced or previously untreated metastatic breast cancer.
Participants will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be
open-label, whereas Arms B and C will be blinded.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01120184
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Public notes
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Contacts
Principal investigator
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Clinical Trials
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Address
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Hoffmann-La Roche
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0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01120184
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