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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
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
Secondary ID [1] 0 0
2009-017905-13
Secondary ID [2] 0 0
BO22589
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Death or Disease Progression According to Independent Review Facility (IRF) Assessment
Assessment method [1] 0 0
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.
Timepoint [1] 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)
Primary outcome [2] 0 0
Progression-Free Survival (PFS) According to IRF Assessment
Assessment method [2] 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, and corresponding confidence intervals (CIs) were computed using the Brookmeyer-Crowley method.
Timepoint [2] 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)
Secondary outcome [1] 0 0
Percentage of Participants Who Died Prior to Clinical Cutoff
Assessment method [1] 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.
Timepoint [1] 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)
Secondary outcome [2] 0 0
Overall Survival (OS) at Clinical Cutoff
Assessment method [2] 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, and corresponding CIs were computed using the Brookmeyer-Crowley method.
Timepoint [2] 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)
Secondary outcome [3] 0 0
Percentage of Participants With Death or Disease Progression According to Investigator Assessment
Assessment method [3] 0 0
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.
Timepoint [3] 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)
Secondary outcome [4] 0 0
PFS According to Investigator Assessment
Assessment method [4] 0 0
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.
Timepoint [4] 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)
Secondary outcome [5] 0 0
Percentage of Participants Experiencing Treatment Failure
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014
Secondary outcome [6] 0 0
Time to Treatment Failure (TTF)
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014
Secondary outcome [7] 0 0
One-Year Survival Rate
Assessment method [7] 0 0
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.
Timepoint [7] 0 0
From randomization until 1 year
Secondary outcome [8] 0 0
Percentage of Participants With Grade =3 Adverse Events
Assessment method [8] 0 0
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.
Timepoint [8] 0 0
Up to 50 months from randomization until clinical cutoff of 16-Sept-2014 (continuously until 28 days after last dose
Secondary outcome [9] 0 0
Percentage of Participants Who Died at 2 Years
Assessment method [9] 0 0
Timepoint [9] 0 0
From randomization until 2 years
Secondary outcome [10] 0 0
Overall Survival Truncated at 2 Years
Assessment method [10] 0 0
Overall Survival truncated at 2 years was defined as the percentage of participants alive at 2 years.
Timepoint [10] 0 0
From randomization until 2 years
Secondary outcome [11] 0 0
Percentage of Participants With Grade 5 Adverse Events
Assessment method [11] 0 0
Adverse events were graded according to NCI CTCAE version 4.0. Grade 5 adverse events are those events which led to death.
Timepoint [11] 0 0
Up to 50 months from randomization until clinical cutoff of 16-Sept-2014 (continuously until 28 days after last dose)
Secondary outcome [12] 0 0
Percentage of Participants With Grade 3-4 Laboratory Parameters
Assessment method [12] 0 0
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.
Timepoint [12] 0 0
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
Secondary outcome [13] 0 0
Percentage of Participants With Decline of =2 Points From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
Assessment method [13] 0 0
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.
Timepoint [13] 0 0
Baseline, Day 1 of every Cycle up to Clinical Data Cut (up to 48 months)
Secondary outcome [14] 0 0
Hospitalization Days
Assessment method [14] 0 0
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.
Timepoint [14] 0 0
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014
Secondary outcome [15] 0 0
Percentage of Participants With Hospitalization
Assessment method [15] 0 0
Hospitalization was defined as a non-administration-related hospitalization due to serious adverse event, while on study treatment.
Timepoint [15] 0 0
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014
Secondary outcome [16] 0 0
Percentage of Participants With Objective Response According to IRF Assessment
Assessment method [16] 0 0
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.
Timepoint [16] 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)
Secondary outcome [17] 0 0
Percentage of Participants With Objective Response According to Investigator Assessment
Assessment method [17] 0 0
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.
Timepoint [17] 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)
Secondary outcome [18] 0 0
Duration of Response According to IRF Assessment
Assessment method [18] 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. 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.
Timepoint [18] 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)
Secondary outcome [19] 0 0
Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD) According to IRF Assessment
Assessment method [19] 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. 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.
Timepoint [19] 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)
Secondary outcome [20] 0 0
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
Assessment method [20] 0 0
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.
Timepoint [20] 0 0
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)
Secondary outcome [21] 0 0
Percentage of Participants Reporting Nausea According to the Relevant Single Items of The FACT Colorectal Cancel (FACT-C) Module
Assessment method [21] 0 0
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.
Timepoint [21] 0 0
At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2
Secondary outcome [22] 0 0
Percentage of Participants Reporting Diarrhea According to the Relevant Single Items of The FACT-C Module
Assessment method [22] 0 0
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.
Timepoint [22] 0 0
At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2
Secondary outcome [23] 0 0
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
Assessment method [23] 0 0
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.
Timepoint [23] 0 0
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)
Secondary outcome [24] 0 0
Time to Deterioration in HRQoL as Assessed by FACT-B TOI-PFB Score
Assessment method [24] 0 0
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.
Timepoint [24] 0 0
Baseline up to 39 months from randomization until clinical cutoff of 16-Sept-2014
Secondary outcome [25] 0 0
Change From Baseline in Rotterdam Symptom Checklist (RSCL) Activity Level Scale Score
Assessment method [25] 0 0
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.
Timepoint [25] 0 0
Baseline, Cycle 7 (Week 18)
Secondary outcome [26] 0 0
Change From Baseline in Work Productivity According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score
Assessment method [26] 0 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)
Timepoint [26] 0 0
Baseline, Cycle 7 (Week 18)
Secondary outcome [27] 0 0
Change From Baseline in Activity Impairment According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score
Assessment method [27] 0 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).
Timepoint [27] 0 0
Baseline, Cycle 7 (Week 18)
Secondary outcome [28] 0 0
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
Assessment method [28] 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. 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.
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)
Secondary outcome [29] 0 0
Percentage of Participants With a Best Overall Response of CR or PR According to IRF Assessment Among Those With Low HER2 mRNA Levels
Assessment method [29] 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. 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.
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)
Secondary outcome [30] 0 0
Percentage of Participants With Death or Disease Progression According to IRF Assessment Among Those With High HER2 mRNA Levels
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.
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)
Secondary outcome [31] 0 0
PFS According to IRF Assessment Among Those With High HER2 mRNA Levels
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.
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)
Secondary outcome [32] 0 0
Percentage of Participants With Death or Disease Progression According to IRF Assessment Among Those With Low HER2 mRNA Levels
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.
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)
Secondary outcome [33] 0 0
PFS According to IRF Assessment Among Those With Low HER2 mRNA Levels
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.
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)
Secondary outcome [34] 0 0
Percentage of Participants Who Died Prior to Clinical Cutoff Among Those With High HER2 mRNA Levels
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.
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)
Secondary outcome [35] 0 0
OS at Clinical Cutoff Among Those With High HER2 mRNA Levels
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.
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)
Secondary outcome [36] 0 0
Percentage of Participants Who Died Prior to Clinical Cutoff Among Those With Low HER2 mRNA Levels
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.
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)
Secondary outcome [37] 0 0
OS at Clinical Cutoff Among Those With Low HER2 mRNA Levels
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.
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)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/07/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/09/2016
Sample size
Target
Accrual to date
Final
1095
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Mater Misericordiae Hospital; Chemotherapy Cottage - Sydney
Recruitment hospital [2] 0 0
Calvary Mater Newcastle; Medical Oncology - Waratah
Recruitment hospital [3] 0 0
Wesley Medical Centre; Clinic For Haematology and Oncology - Auchenflower
Recruitment hospital [4] 0 0
Royal Adelaide Hospital; Oncology - Adelaide
Recruitment hospital [5] 0 0
Peter Maccallum Cancer Institute; Medical Oncology - Melbourne
Recruitment postcode(s) [1] 0 0
2060 - Sydney
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Hawaii
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Maine
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Minnesota
Country [16] 0 0
United States of America
State/province [16] 0 0
Missouri
Country [17] 0 0
United States of America
State/province [17] 0 0
New Hampshire
Country [18] 0 0
United States of America
State/province [18] 0 0
New Jersey
Country [19] 0 0
United States of America
State/province [19] 0 0
New Mexico
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
North Dakota
Country [23] 0 0
United States of America
State/province [23] 0 0
Ohio
Country [24] 0 0
United States of America
State/province [24] 0 0
Pennsylvania
Country [25] 0 0
United States of America
State/province [25] 0 0
South Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
South Dakota
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Utah
Country [30] 0 0
United States of America
State/province [30] 0 0
Washington
Country [31] 0 0
Argentina
State/province [31] 0 0
Buenos Aires
Country [32] 0 0
Argentina
State/province [32] 0 0
San Miguel de Tucuman
Country [33] 0 0
Austria
State/province [33] 0 0
Salzburg
Country [34] 0 0
Austria
State/province [34] 0 0
Wien
Country [35] 0 0
Bahamas
State/province [35] 0 0
Nassau
Country [36] 0 0
Belgium
State/province [36] 0 0
Bruxelles
Country [37] 0 0
Belgium
State/province [37] 0 0
Namur
Country [38] 0 0
Belgium
State/province [38] 0 0
Wilrijk
Country [39] 0 0
Bosnia and Herzegovina
State/province [39] 0 0
Banja Luka
Country [40] 0 0
Bosnia and Herzegovina
State/province [40] 0 0
Sarajevo
Country [41] 0 0
Brazil
State/province [41] 0 0
RJ
Country [42] 0 0
Brazil
State/province [42] 0 0
RN
Country [43] 0 0
Brazil
State/province [43] 0 0
RS
Country [44] 0 0
Brazil
State/province [44] 0 0
SC
Country [45] 0 0
Brazil
State/province [45] 0 0
SP
Country [46] 0 0
Canada
State/province [46] 0 0
Alberta
Country [47] 0 0
Canada
State/province [47] 0 0
Ontario
Country [48] 0 0
Canada
State/province [48] 0 0
Quebec
Country [49] 0 0
Colombia
State/province [49] 0 0
Bogota
Country [50] 0 0
Colombia
State/province [50] 0 0
Bucaramanga
Country [51] 0 0
Colombia
State/province [51] 0 0
Cali
Country [52] 0 0
Colombia
State/province [52] 0 0
Pasto
Country [53] 0 0
Czechia
State/province [53] 0 0
Brno
Country [54] 0 0
Czechia
State/province [54] 0 0
Olomouc
Country [55] 0 0
Czechia
State/province [55] 0 0
Praha 2
Country [56] 0 0
Czechia
State/province [56] 0 0
Praha
Country [57] 0 0
Denmark
State/province [57] 0 0
Vejle
Country [58] 0 0
France
State/province [58] 0 0
Besancon
Country [59] 0 0
France
State/province [59] 0 0
Clermont Ferrand
Country [60] 0 0
France
State/province [60] 0 0
Lille
Country [61] 0 0
France
State/province [61] 0 0
Marseille
Country [62] 0 0
France
State/province [62] 0 0
Montpellier
Country [63] 0 0
France
State/province [63] 0 0
Nancy
Country [64] 0 0
France
State/province [64] 0 0
Paris
Country [65] 0 0
France
State/province [65] 0 0
Poitiers
Country [66] 0 0
France
State/province [66] 0 0
Saint Cloud
Country [67] 0 0
France
State/province [67] 0 0
St Priest En Jarez
Country [68] 0 0
Germany
State/province [68] 0 0
Essen
Country [69] 0 0
Germany
State/province [69] 0 0
Halle
Country [70] 0 0
Germany
State/province [70] 0 0
Hamburg
Country [71] 0 0
Germany
State/province [71] 0 0
Hannover
Country [72] 0 0
Germany
State/province [72] 0 0
Heidelberg
Country [73] 0 0
Germany
State/province [73] 0 0
Magdeburg
Country [74] 0 0
Germany
State/province [74] 0 0
Mainz
Country [75] 0 0
Germany
State/province [75] 0 0
Minden
Country [76] 0 0
Germany
State/province [76] 0 0
Muenchen
Country [77] 0 0
Germany
State/province [77] 0 0
Trier
Country [78] 0 0
Greece
State/province [78] 0 0
Athens
Country [79] 0 0
Greece
State/province [79] 0 0
Heraklion
Country [80] 0 0
Greece
State/province [80] 0 0
Larissa
Country [81] 0 0
Guatemala
State/province [81] 0 0
Guatemala City
Country [82] 0 0
Guatemala
State/province [82] 0 0
Guatemala
Country [83] 0 0
Hungary
State/province [83] 0 0
Budapest
Country [84] 0 0
Hungary
State/province [84] 0 0
Pécs
Country [85] 0 0
Italy
State/province [85] 0 0
Calabria
Country [86] 0 0
Italy
State/province [86] 0 0
Emilia-Romagna
Country [87] 0 0
Italy
State/province [87] 0 0
Friuli-Venezia Giulia
Country [88] 0 0
Italy
State/province [88] 0 0
Lombardia
Country [89] 0 0
Italy
State/province [89] 0 0
Sicilia
Country [90] 0 0
Italy
State/province [90] 0 0
Toscana
Country [91] 0 0
Italy
State/province [91] 0 0
Umbria
Country [92] 0 0
Japan
State/province [92] 0 0
Aichi
Country [93] 0 0
Japan
State/province [93] 0 0
Ehime
Country [94] 0 0
Japan
State/province [94] 0 0
Fukuoka
Country [95] 0 0
Japan
State/province [95] 0 0
Gifu
Country [96] 0 0
Japan
State/province [96] 0 0
Hiroshima
Country [97] 0 0
Japan
State/province [97] 0 0
Hokkaido
Country [98] 0 0
Japan
State/province [98] 0 0
Hyogo
Country [99] 0 0
Japan
State/province [99] 0 0
Ishikawa
Country [100] 0 0
Japan
State/province [100] 0 0
Iwate
Country [101] 0 0
Japan
State/province [101] 0 0
Kagoshima
Country [102] 0 0
Japan
State/province [102] 0 0
Kanagawa
Country [103] 0 0
Japan
State/province [103] 0 0
Kumamoto
Country [104] 0 0
Japan
State/province [104] 0 0
Kyoto
Country [105] 0 0
Japan
State/province [105] 0 0
Miyagi
Country [106] 0 0
Japan
State/province [106] 0 0
Niigata
Country [107] 0 0
Japan
State/province [107] 0 0
Okayama
Country [108] 0 0
Japan
State/province [108] 0 0
Osaka
Country [109] 0 0
Japan
State/province [109] 0 0
Saitama
Country [110] 0 0
Japan
State/province [110] 0 0
Shizuoka
Country [111] 0 0
Japan
State/province [111] 0 0
Tokyo
Country [112] 0 0
Korea, Republic of
State/province [112] 0 0
Gyeonggi-do
Country [113] 0 0
Korea, Republic of
State/province [113] 0 0
Seoul
Country [114] 0 0
Malaysia
State/province [114] 0 0
FED. Territory OF Kuala Lumpur
Country [115] 0 0
Malaysia
State/province [115] 0 0
Selangor
Country [116] 0 0
Mexico
State/province [116] 0 0
Guerrero
Country [117] 0 0
Mexico
State/province [117] 0 0
Nuevo LEON
Country [118] 0 0
Mexico
State/province [118] 0 0
Oaxaca
Country [119] 0 0
Mexico
State/province [119] 0 0
Sonora
Country [120] 0 0
Mexico
State/province [120] 0 0
Aguascalientes
Country [121] 0 0
Mexico
State/province [121] 0 0
Toluca
Country [122] 0 0
New Zealand
State/province [122] 0 0
Auckland
Country [123] 0 0
New Zealand
State/province [123] 0 0
Hamilton
Country [124] 0 0
North Macedonia
State/province [124] 0 0
Skopje
Country [125] 0 0
Panama
State/province [125] 0 0
Panama
Country [126] 0 0
Peru
State/province [126] 0 0
Arequipa
Country [127] 0 0
Peru
State/province [127] 0 0
Lima
Country [128] 0 0
Peru
State/province [128] 0 0
Piura
Country [129] 0 0
Philippines
State/province [129] 0 0
Cebu City
Country [130] 0 0
Philippines
State/province [130] 0 0
San Juan
Country [131] 0 0
Poland
State/province [131] 0 0
Bydgoszcz
Country [132] 0 0
Poland
State/province [132] 0 0
Gdansk
Country [133] 0 0
Poland
State/province [133] 0 0
Krakow
Country [134] 0 0
Poland
State/province [134] 0 0
Lublin
Country [135] 0 0
Poland
State/province [135] 0 0
Warszawa
Country [136] 0 0
Portugal
State/province [136] 0 0
Porto
Country [137] 0 0
Romania
State/province [137] 0 0
Bucharest
Country [138] 0 0
Romania
State/province [138] 0 0
Cluj Napoca
Country [139] 0 0
Romania
State/province [139] 0 0
Cluj-Napoca
Country [140] 0 0
Russian Federation
State/province [140] 0 0
Moskovskaja Oblast
Country [141] 0 0
Russian Federation
State/province [141] 0 0
Rjazan
Country [142] 0 0
Russian Federation
State/province [142] 0 0
Stavropol
Country [143] 0 0
Russian Federation
State/province [143] 0 0
Tatarstan
Country [144] 0 0
Russian Federation
State/province [144] 0 0
Ivanovo
Country [145] 0 0
Russian Federation
State/province [145] 0 0
Samara
Country [146] 0 0
Russian Federation
State/province [146] 0 0
Tula
Country [147] 0 0
Russian Federation
State/province [147] 0 0
Vladimir
Country [148] 0 0
Spain
State/province [148] 0 0
Alicante
Country [149] 0 0
Spain
State/province [149] 0 0
Barcelona
Country [150] 0 0
Spain
State/province [150] 0 0
LA Coruña
Country [151] 0 0
Spain
State/province [151] 0 0
Jaen
Country [152] 0 0
Spain
State/province [152] 0 0
La Coruña
Country [153] 0 0
Spain
State/province [153] 0 0
Madrid
Country [154] 0 0
Spain
State/province [154] 0 0
Malaga
Country [155] 0 0
Spain
State/province [155] 0 0
Valencia
Country [156] 0 0
Sweden
State/province [156] 0 0
Malmö
Country [157] 0 0
Switzerland
State/province [157] 0 0
Baden
Country [158] 0 0
Switzerland
State/province [158] 0 0
Basel
Country [159] 0 0
Switzerland
State/province [159] 0 0
Chur
Country [160] 0 0
Taiwan
State/province [160] 0 0
Changhua
Country [161] 0 0
Taiwan
State/province [161] 0 0
Kaohsiung
Country [162] 0 0
Taiwan
State/province [162] 0 0
Taipei
Country [163] 0 0
Thailand
State/province [163] 0 0
Bangkok
Country [164] 0 0
Thailand
State/province [164] 0 0
Chiang Mai
Country [165] 0 0
Thailand
State/province [165] 0 0
Songkhla
Country [166] 0 0
Turkey
State/province [166] 0 0
Adana
Country [167] 0 0
Turkey
State/province [167] 0 0
Ankara
Country [168] 0 0
Turkey
State/province [168] 0 0
Izmir
Country [169] 0 0
United Kingdom
State/province [169] 0 0
Bristol
Country [170] 0 0
United Kingdom
State/province [170] 0 0
Cambridge
Country [171] 0 0
United Kingdom
State/province [171] 0 0
Cornwall
Country [172] 0 0
United Kingdom
State/province [172] 0 0
Glasgow
Country [173] 0 0
United Kingdom
State/province [173] 0 0
Leicester
Country [174] 0 0
United Kingdom
State/province [174] 0 0
London
Country [175] 0 0
United Kingdom
State/province [175] 0 0
Manchester
Country [176] 0 0
United Kingdom
State/province [176] 0 0
Nottingham
Country [177] 0 0
United Kingdom
State/province [177] 0 0
Peterborough
Country [178] 0 0
United Kingdom
State/province [178] 0 0
Portsmouth
Country [179] 0 0
United Kingdom
State/province [179] 0 0
Sheffield
Country [180] 0 0
United Kingdom
State/province [180] 0 0
Southampton
Country [181] 0 0
United Kingdom
State/province [181] 0 0
Stoke-on-Trent
Country [182] 0 0
United Kingdom
State/province [182] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Genentech, Inc.
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
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/NCT01120184