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A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01120184
First Posted: May 10, 2010
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition Intervention Phase
Breast Cancer Drug: docetaxel Drug: paclitaxel Drug: pertuzumab Drug: pertuzumab-placebo Drug: trastuzumab [Herceptin] Drug: trastuzumab emtansine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Death or Disease Progression According to Independent Review Facility (IRF) Assessment [ Time Frame: 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) ]
    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.

  • Progression-Free Survival (PFS) According to IRF Assessment [ Time Frame: 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) ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants Who Died Prior to Clinical Cutoff [ Time Frame: 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) ]
    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.

  • Overall Survival (OS) at Clinical Cutoff [ Time Frame: 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) ]
    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.

  • Percentage of Participants With Death or Disease Progression According to Investigator Assessment [ Time Frame: 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) ]
    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.

  • PFS According to Investigator Assessment [ Time Frame: 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) ]
    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.

  • Percentage of Participants Experiencing Treatment Failure [ Time Frame: Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 ]
    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.

  • Time to Treatment Failure (TTF) [ Time Frame: Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 ]
    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.

  • One-Year Survival Rate [ Time Frame: From randomization until 1 year ]
    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.

  • Percentage of Participants With Grade ≥3 Adverse Events [ Time Frame: Up to 50 months from randomization until clinical cutoff of 16-Sept-2014 (continuously until 28 days after last dose ]
    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.

  • Percentage of Participants Who Died at 2 Years [ Time Frame: From randomization until 2 years ]
  • Overall Survival Truncated at 2 Years [ Time Frame: From randomization until 2 years ]
    Overall Survival truncated at 2 years was defined as the percentage of participants alive at 2 years.

  • Percentage of Participants With Grade 5 Adverse Events [ Time Frame: Up to 50 months from randomization until clinical cutoff of 16-Sept-2014 (continuously until 28 days after last dose) ]
    Adverse events were graded according to NCI CTCAE version 4.0. Grade 5 adverse events are those events which led to death.

  • Percentage of Participants With Grade 3-4 Laboratory Parameters [ Time Frame: 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 ]
    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.

  • Percentage of Participants With Decline of ≥2 Points From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status [ Time Frame: Baseline, Day 1 of every Cycle up to Clinical Data Cut (up to 48 months) ]
    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.

  • Hospitalization Days [ Time Frame: Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 ]
    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.

  • Percentage of Participants With Hospitalization [ Time Frame: Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 ]
    Hospitalization was defined as a non-administration-related hospitalization due to serious adverse event, while on study treatment.

  • Percentage of Participants With Objective Response According to IRF Assessment [ Time Frame: 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) ]
    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.

  • Percentage of Participants With Objective Response According to Investigator Assessment [ Time Frame: 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) ]
    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.

  • Duration of Response According to IRF Assessment [ Time Frame: 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) ]
    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.

  • Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD) According to IRF Assessment [ Time Frame: 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) ]
    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.

  • 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 [ Time Frame: 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) ]
    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.

  • Percentage of Participants Reporting Nausea According to the Relevant Single Items of The FACT Colorectal Cancel (FACT-C) Module [ Time Frame: At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2 ]
    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.

  • Percentage of Participants Reporting Diarrhea According to the Relevant Single Items of The FACT-C Module [ Time Frame: At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2 ]
    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.

  • 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 [ Time Frame: 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) ]
    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.

  • Time to Deterioration in HRQoL as Assessed by FACT-B TOI-PFB Score [ Time Frame: Baseline up to 39 months from randomization until clinical cutoff of 16-Sept-2014 ]
    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.

  • Change From Baseline in Rotterdam Symptom Checklist (RSCL) Activity Level Scale Score [ Time Frame: Baseline, Cycle 7 (Week 18) ]
    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.

  • Change From Baseline in Work Productivity According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score [ Time Frame: Baseline, Cycle 7 (Week 18) ]
    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)

  • Change From Baseline in Activity Impairment According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score [ Time Frame: Baseline, Cycle 7 (Week 18) ]
    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).

  • 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 [ Time Frame: 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) ]
    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.

  • Percentage of Participants With a Best Overall Response of CR or PR According to IRF Assessment Among Those With Low HER2 mRNA Levels [ Time Frame: 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) ]
    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.

  • Percentage of Participants With Death or Disease Progression According to IRF Assessment Among Those With High HER2 mRNA Levels [ Time Frame: 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) ]
    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.

  • PFS According to IRF Assessment Among Those With High HER2 mRNA Levels [ Time Frame: 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) ]
    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.

  • Percentage of Participants With Death or Disease Progression According to IRF Assessment Among Those With Low HER2 mRNA Levels [ Time Frame: 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) ]
    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.

  • PFS According to IRF Assessment Among Those With Low HER2 mRNA Levels [ Time Frame: 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) ]
    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.

  • Percentage of Participants Who Died Prior to Clinical Cutoff Among Those With High HER2 mRNA Levels [ Time Frame: 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) ]
    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.

  • OS at Clinical Cutoff Among Those With High HER2 mRNA Levels [ Time Frame: 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) ]
    OS was defined as the time from randomization to death from any cause. Median duration of OS was estimated using Kaplan-Meier analysis.

  • Percentage of Participants Who Died Prior to Clinical Cutoff Among Those With Low HER2 mRNA Levels [ Time Frame: 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) ]
    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.

  • OS at Clinical Cutoff Among Those With Low HER2 mRNA Levels [ Time Frame: 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) ]
    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.


Enrollment: 1095
Actual Study Start Date: July 31, 2010
Study Completion Date: September 16, 2016
Primary Completion Date: September 30, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trastuzumab + Taxane (docetaxel or paclitaxel) Drug: docetaxel
75 mg/m2 or 100 mg/m2 intravenously every 3 weeks for a minimum of 6 cycles.
Drug: paclitaxel
80 mg/m2 intravenously weekly for a minimum of 18 weeks
Drug: 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.
Experimental: Trastuzumab emtansine + pertuzumab Drug: pertuzumab
840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles
Drug: trastuzumab emtansine
3.6 mg/kg intravenously every 3 weeks
Experimental: Trastuzumab emtansine + pertuzumab placebo Drug: pertuzumab-placebo
840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles
Drug: trastuzumab emtansine
3.6 mg/kg intravenously every 3 weeks

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01120184


  Hide Study Locations
Locations
United States, Arizona
Arizona Oncology
Tucson, Arizona, United States, 85704
United States, Arkansas
Uni of Arkansas For Medical Sciences; Arkansas Cancer Research Center
Little Rock, Arkansas, United States, 72204
Little Rock Hematology Oncology Associates, PA
Little Rock, Arkansas, United States, 72205
United States, California
Scripps Cancer Center
La Jolla, California, United States, 92037
University of California; Moores Cancer Center
La Jolla, California, United States, 92093
Clnc L Trials & Rsch Assoc-Inc
Montebello, California, United States, 90640
Global Oncology, Inc.
Monterey Park, California, United States, 91754
Southern California Kaiser Permanente
San Diego, California, United States, 92108
Sharp Healthcare; Oncology Research Program
San Diego, California, United States, 92123
Breastlink Medical Group Inc
Santa Ana, California, United States, 92705
Kaiser Permanente; Oncology Clinical Trials
Vallejo, California, United States, 94589
United States, Colorado
Uni of Colorado Cancer Center; Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
United States, Connecticut
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States, 06510
United States, Delaware
Christiana Care Health Srvcs
Newark, Delaware, United States, 19713
United States, District of Columbia
Washington Cancer Institute; Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Innovative Medical Research of South Florida
Aventura, Florida, United States, 33180
Northwest Oncology/ Hematology Assoc.
Coral Springs, Florida, United States, 33065-5701
Florida Cancer Specialists; SCRI
Fort Myers, Florida, United States, 33901
Mayo Clinic-Jacksonville
Jacksonville, Florida, United States, 32224
Hematology Oncology Associates
Loxahatchee, Florida, United States, 33470
Uni of Miami School of Medicine; Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Georgia
University Cancer & Blood Center, LLC
Athens, Georgia, United States, 30607
Northeast Georgia Medical Center; Oncology Research Dept-5C
Gainesville, Georgia, United States, 30501
United States, Hawaii
Cancer Research Center of Hawaii; Clinical Sciences
Honolulu, Hawaii, United States, 96813
United States, Idaho
Mountain States Tumor Inst.
Boise, Idaho, United States, 83712
United States, Illinois
Uni of Chicago
Chicago, Illinois, United States, 60637
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Loyola University Med Center
Maywood, Illinois, United States, 60153
Illinois Cancer Care
Peoria, Illinois, United States, 61615
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Horizon Oncology Research, Inc.
Lafayette, Indiana, United States, 47905
United States, Iowa
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Siouxland Hematology/Oncology
Sioux City, Iowa, United States, 51101
United States, Kentucky
James Graham Brown Cancer Center, University of Louisville
Louisville, Kentucky, United States, 40202
United States, Maine
New England Cancer Specialists
Scarborough, Maine, United States, 04074
York Hospital
York, Maine, United States, 03909
United States, Maryland
Anne Arundel Health System Research Instit-Annapolis Oncology Ctr
Annapolis, Maryland, United States, 21401
Mercy Medical Center; Medical Oncology & Hematology
Baltimore, Maryland, United States, 21202
Suburban Hospital
Bethesda, Maryland, United States, 20817
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Spectrum Health Grand Rapids
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
St. Mary's Duluth Clinic Heath System
Duluth, Minnesota, United States, 55805
University of Minnesota.
Minneapolis, Minnesota, United States, 55454
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55902
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States, 55416
United States, Missouri
Columbia Comprehensive Cancer Center Clinic
Jefferson City, Missouri, United States, 65109
St. John'S Mercy Medical Center; David C. Pratt Cancer Center
Saint Louis, Missouri, United States, 63141
Mercy Clinic Cancer & Hematology
Springfield, Missouri, United States, 65804
United States, Nebraska
Nebraska Methodist Hospital; Cancer Center
Omaha, Nebraska, United States, 68114
United States, New Hampshire
Dartmouth Hitchcock Med Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Hackensack Uni Medical Center; Northern Nj Cancer Center
Hackensack, New Jersey, United States, 07601
Cancer Inst. of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, New Mexico
Presbyterian Medical Group
Albuquerque, New Mexico, United States, 87110
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-0001
San Juan Oncology Associates
Farmington, New Mexico, United States, 87401
United States, New York
New York Oncology Hematology, P.C.
Albany, New York, United States, 12208
Queens Medical Associates
Fresh Meadows, New York, United States, 11366
Queens Hospital Center
Jamaica, New York, United States, 11432
Arena Oncology Associates
Lake Success, New York, United States, 11042
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Weill Medical College of Cornell Uni
New York, New York, United States, 10065
United States, North Carolina
Carolinas Hem-Oncology Assoc
Charlotte, North Carolina, United States, 28203
Carolina Oncology Specialists, PA - Hickory
Hickory, North Carolina, United States, 28602
Marion L. Shepard Cancer Center
Washington, North Carolina, United States, 27889
United States, North Dakota
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122-9988
United States, Ohio
Oncology Hematology Care - SCRI
Cincinnati, Ohio, United States, 45242
United States, Oregon
Providence Portland Medical Ctr
Portland, Oregon, United States, 97225
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, Rhode Island
Pharma Resource
East Providence, Rhode Island, United States, 02915
United States, South Carolina
Charleston Hematology Oncology
Charleston, South Carolina, United States, 29414
Medical University of SC (MUSC)
Charleston, South Carolina, United States, 29425
South Carolina Oncology Associates - SCRI
Columbia, South Carolina, United States, 29210
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee, United States, 37404
West Clinic
Germantown, Tennessee, United States, 38138
Uni of Tennessee Cancer Inst.
Memphis, Tennessee, United States, 38104
Tennessee Onc., PLLC - SCRI
Nashville, Tennessee, United States, 37203
Vanderbilt-Ingram Cancer Ctr
Nashville, Tennessee, United States, 37232
United States, Texas
The Don & Sybil Harrington Cancer Center; Department of Clinical Research
Amarillo, Texas, United States, 79106
Uni of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-9063
Uni of Texas - Md Anderson Cancer Center; Dept of Breast Medical Oncology
Houston, Texas, United States, 77030
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78217
United States, Utah
Northern Utah Associates
Ogden, Utah, United States, 84403
United States, Washington
The Providence Regional Medical Center Everett
Everett, Washington, United States, 98201
University of Washington
Seattle, Washington, United States, 98195
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Providence St. Mary Regional Cancer Center
Walla Walla, Washington, United States, 99362
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Argentina
Fundación Investigar
Buenos Aires, Argentina, 1025
CER Instituto Médico Oncología
Florencio Varela, Argentina, B1878DVB
Centro Medico San Roque
San Miguel de Tucuman, Argentina, T4000IAK
Australia, New South Wales
Mater Misericordiae Hospital; Chemotherapy Cottage
Sydney, New South Wales, Australia, 2060
Calvary Mater Newcastle; Medical Oncology
Waratah, New South Wales, Australia, 2298
Australia, Queensland
Wesley Medical Centre; Clinic For Haematology and Oncology
Auchenflower, Queensland, Australia, 4066
Australia, South Australia
Royal Adelaide Hospital; Oncology
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Peter Maccallum Cancer Institute; Medical Oncology
Melbourne, Victoria, Australia, 3000
Austria
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Salzburg, Austria, 5020
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
Wien, Austria, 1090
Bahamas
Oncology Consultants Limited
Nassau, Bahamas, 09311
Belgium
Cliniques Universitaires St-Luc
Bruxelles, Belgium, 1200
Clinique Ste-Elisabeth
Namur, Belgium, 5000
Sint Augustinus Wilrijk
Wilrijk, Belgium, 2610
Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska
Banja Luka, Bosnia and Herzegovina, 78000
Clinic of Oncology, University Clinical Center Sarajevo
Sarajevo, Bosnia and Herzegovina, 71000
Brazil
Instituto Nacional do Cancer - INCA
Rio de Janeiro, RJ, Brazil, 20560-120
Liga Norte Riograndense Contra O Câncer
Natal, RN, Brazil, 59040150
Clinica de Oncologia de Porto Alegre - CliniOnco
Porto Alegre, RS, Brazil, 90430-090
Hospital Sao Lucas - PUCRS
Porto Alegre, RS, Brazil, 90610-000
Hospital Nossa Senhora da Conceicao
Porto Alegre, RS, Brazil, 91350-200
Clinica de Neoplasias Litoral
Itajai, SC, Brazil, 88301-220
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo, SP, Brazil, 01246-000
Hospital Perola Byington
Sao Paulo, SP, Brazil, 01317-000
Canada, Alberta
Cross Cancer Institute; Clinical Trials
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
North York General Hospital
Toronto, Ontario, Canada, M2K 1E1
Canada, Quebec
Cuse - Centre Universitaire De Sante; Site Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
Canada
CHU de Québec - Hôpital du Saint-Sacrement / ONCOLOGY
Quebec, Canada, G1S 4L8
Colombia
Clinica del Country
Bogota, Colombia, 11001
Instituto Colombiano Para El Avance De La Medicina: Icamedic
Bucaramanga, Colombia
Centro Medico Imbanaco
Cali, Colombia
Instituto Cancerologico de Nariño
Pasto, Colombia
Czechia
Masarykuv onkologicky ustav
Brno, Czechia, 656 53
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, Czechia, 779 00
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
Praha 2, Czechia, 128 08
Fakultni Nemocnice Na Bulovce; Ustav Radiacni Onkologie
Praha, Czechia, 180 00
Denmark
Nordsjællands Hospital, Hillerød, Onkologisk Afdeling
Hillerod, Denmark, 3400
Vejle Sygehus Onkologisk Afd
Vejle, Denmark, 7100
France
HOPITAL JEAN MINJOZ; Oncologie
Besancon, France, 25030
Centre Jean Perrin; Hopital De Jour
Clermont Ferrand, France, 63011
Centre Oscar Lambret; Senologie
Lille, France, 59020
Institut Paoli Calmettes; Oncologie Medicale
Marseille, France, 13273
Institut régional du Cancer Montpellier
Montpellier, France, 34298
Centre D'Oncologie de Gentilly; Oncology
Nancy, France, 54100
Institut Curie; Oncologie Medicale
Paris, France, 75231
Hopital Saint Louis; Service Onco Thoracique
Paris, France, 75475
HOPITAL TENON; Cancerologie Medicale
Paris, France, 75970
Chu La Miletrie; Radiotherapie
Poitiers, France, 86021
Centre Rene Huguenin; ONCOLOGIE GENETIQUE
Saint Cloud, France, 92210
Institut de Cancerologie de La Loire; Radiotherapie
St Priest En Jarez, France, 42271
Germany
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
Essen, Germany, 45136
Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie
Halle, Germany, 06120
Facharztzentrum Eppendorf, Studien GbR
Hamburg, Germany, 20249
Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding
Hannover, Germany, 30177
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
Heidelberg, Germany, 69120
Universitätsklinikum Magdeburg; Frauenheilkunde & Geburtshilfe
Magdeburg, Germany, 39108
Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
Mainz, Germany, 55131
Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe
Minden, Germany, 32429
Rotkreuzklinikum München; Frauenklinik
Muenchen, Germany, 80637
Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
Trier, Germany, 54290
Greece
Alexandras General Hospital of Athens; Oncology Department
Athens, Greece, 115 28
Univ General Hosp Heraklion; Medical Oncology
Heraklion, Greece, 711 10
University Hospital of Larissa; Oncology
Larissa, Greece, 41 110
Guatemala
Grupo Angeles
Guatemala City, Guatemala, 01015
Centro Oncológico Sixtino / Centro Oncológico SA
Guatemala, Guatemala, 01010
Hungary
Szent Margit Hospital; Dept. of Oncology
Budapest, Hungary, 1032
Semmelweis Egyetem Onkologiai Központ
Budapest, Hungary, 1083
Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
Budapest, Hungary, 1125
Pécsi Tudományegyetem Áok; Onkoterapias Intezet
Pecs, Hungary, 7623
Italy
Campus Universitario S.Venuta; Centro Oncologico T.Campanella
Catanzaro, Calabria, Italy, 88100
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, Italy, 47014
A.O. Universitaria Policlinico Di Modena; Ematologia
Modena, Emilia-Romagna, Italy, 41100
Arcispedale Santa Maria Nuova; Oncologia
Reggio Emilia, Emilia-Romagna, Italy, 42100
Ospedale Degli Infermi; Divisione Di Oncologia
Rimini, Emilia-Romagna, Italy, 47900
Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
Udine, Friuli-Venezia Giulia, Italy, 33100
Istituto Europeo Di Oncologia
Milano, Lombardia, Italy, 20141
Fondazione Salvatore Maugeri
Pavia, Lombardia, Italy, 27100
IRCCS Istituto Clinico Humanitas; Oncologia
Rozzano, Lombardia, Italy, 20089
Centro Catanese Di Oncologia; Oncologia Medica
Catania, Sicilia, Italy, 95126
Ospedale Papardo- Piemonte;Oncologia Medica
Messina, Sicilia, Italy, 98158
Ospedale Misericordia E Dolce; Oncologia Medica
Prato, Toscana, Italy, 59100
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
Perugia, Umbria, Italy, 06156
A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.
Verona, Veneto, Italy, 37126
Japan
Mikawa Breast Cancer Clinic; Breast Surgery
Aichi, Japan, 446-0073
Aichi Cancer Center Hospital, Breast Oncology
Aichi, Japan, 464-8681
Natl Hosp Org Shikoku; Cancer Ctr, Surgery
Ehime, Japan, 791-0280
Kitakyushu Municipal Medical Center; Surgery
Fukuoka, Japan, 802-0077
National Hospital Organization Kyushu Cancer Center;Breast Oncology
Fukuoka, Japan, 811-1395
Gifu University Hospital; Second Department of Surgery
Gifu, Japan, 501-1194
Gunma University Hospital; Department of Breast and Endocrine Surgery
Gunma, Japan, 371-8511
Hiroshima University Hospital; Breast Surgery
Hiroshima, Japan, 734-8551
National Hospital Organization Hokkaido Cancer Center; Breast Surgery
Hokkaido, Japan, 003-0804
Hyogo College Of Medicine; Breast And Endocrine Surgery
Hyogo, Japan, 663-8501
Hyogo Cancer Center; Breast Surgery
Hyogo, Japan, 673-8558
Kanazawa University Hospital; Breast Oncology
Ishikawa, Japan, 920-8641
Iwate Med Univ School of Med; Surgery
Iwate, Japan, 020-8505
Sagara Hospital; Breast Surgery
Kagoshima, Japan, 892-0833
St. Marianna University School of Medicine Hospital, Breast and Endocrine Surgery
Kanagawa, Japan, 216-8511
Tokai University Hospital, Breast and Endocrine Surgery
Kanagawa, Japan, 259-1193
Kumamoto University Hospital; Breast and Endocrine Surgery
Kumamoto, Japan, 860-8556
Kumamoto City Hospital, Breast and Endocrine Surgery
Kumamoto, Japan, 862-8505
Kyoto University Hospital; Breast Surgery
Kyoto, Japan, 606-8507
Tohoku University Hospital; Breast And Endocrine Surgery
Miyagi, Japan, 980-8574
Niigata Cancer Ctr Hospital; Breast Surgery
Niigata, Japan, 951-8566
Okayama University Hospital; Breast, Thyroid Surgery
Okayama, Japan, 700-8558
Kawasaki Medical School Hospital; Breast and Thyroid Surgery
Okayama, Japan, 701-0114
National Hospital Organization Osaka National Hospital; Breast Surgery
Osaka, Japan, 540-0006
Osaka University Hospital; Breast and Endocrine Surgery
Osaka, Japan, 565-0871
Saitama Medical University International Medical Center; Medical Oncology
Saitama, Japan, 350-1298
Saitama Cancer Center, Breast Oncology
Saitama, Japan, 362-0806
Shizuoka Cancer Center; Female Internal Medicine
Shizuoka, Japan, 411-8777
Shizuoka General Hospital; Breast Surgery
Shizuoka, Japan, 420-8527
Jichi Medical University; Breast Oncology
Tochigi, Japan, 329-0498
National Cancer Center Hospital; Breast and Medical Oncology
Tokyo, Japan, 104-0045
Toranomon Hospital; Breast and Endocrine Surgery
Tokyo, Japan, 105-8470
The Cancer Inst. Hosp. of JFCR; Breast Oncology Center
Tokyo, Japan, 135-8550
Showa University Hospital; Breast Surgery
Tokyo, Japan, 142-8666
Tokyo Medical Uni. Hospital; Breast Oncology
Tokyo, Japan, 160-0023
Kyorin University Hospital; Breast Surgery
Tokyo, Japan, 181-8611
Korea, Republic of
Seoul National University Bundang Hospital; Hematology Medical Oncology
Gyeonggi-do, Korea, Republic of, 463-707
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
Seoul, Korea, Republic of, 03080
Samsung Medical Centre; Division of Hematology/Oncology
Seoul, Korea, Republic of, 135-710
Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology
Seoul, Korea, Republic of, 138-736
Korea University Guro Hospital; Oncology
Seoul, Korea, Republic of, 152-703
Macedonia, The Former Yugoslav Republic of
Private Health Organization Acibadem Sistina Hospital
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Malaysia
Beacon International Specialist Centre
Petaling Jaya, Selangor, Selangor, Malaysia, 46050
Pantai Hospital Kuala Lumpur; Dept of Oncology & Radiotherapy
Kuala Lumpur, Malaysia, 59100
Sunway Medical Centre
Selangor, Malaysia, 46150
Mexico
Centro de Investigacion; Clinica Del Pacifico
Acapulco, Mexico, 39670
Centenario Hospital Miguel Hidalgo
Aguascalientes, Mexico, 20230
Núcleo de Especialidades Oncológicas
Guadalajara, Mexico, 44670
Centro Universitario Contra El Cancer
Monterrey, Mexico, 64020
Oaxaca Site Management Organization
Oaxaca, Mexico, 68000
Hospital Privado San Jose; Oncologia
Obregon, Mexico, 85000
Centro Oncológico Estatal; ISSSEMYM Oncología
Toluca, Mexico, 50180
New Zealand
Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
Auckland, New Zealand, 1023
Waikato Hospital; Regional Cancer Center
Hamilton, New Zealand
Panama
Centro Hemato Oncologico Paitilla
Panama City, Panama, 083200752
Peru
Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology
Arequipa, Peru, 04001
Hospital Nacional Edgardo Rebagliati Martins; Oncologia
Lima, Peru, 11
Unidad de Investigacion Oncologia Clinica - Piura; Unidad de Oncología Clínica
Piura, Peru, 20011
Philippines
Cebu Cancer Institute; Perpetual Succour Hospital
Cebu, Philippines, 6000
Cardinal Santos Medical Center
San Juan, Philippines, 1502
Poland
Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
Bydgoszcz, Poland, 85-796
Medical University of Gdansk
Gdansk, Poland, 80-211
Centrum Onkologii, Instytut, Klinika Chemioterapii; Oddzial Chemoterapii
Krakow, Poland, 31-115
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
Lublin, Poland, 20-090
Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon
Warszawa, Poland, 02-781
Portugal
IPO do Porto; Servico de Oncologia Medica
Porto, Portugal, 4200-072
Romania
Coltea Hospital; Oncology
Bucharest, Romania
Prof. Dr. I. Chiricuta Institute of Oncology
Cluj Napoca, Romania, 400015
Cluj Clinical County Hospital; Oncology Dept
Cluj-Napoca, Romania, 400006
Russian Federation
Ivanovo Regional Oncology Dispensary
Ivanovo, Russian Federation, 153040
Clinical Oncology Dispensary of Ministry of Health of Tatarstan
Kazan, Russian Federation, 420029
Blokhin Cancer Research Center; Combined Treatment
Moscow, Russian Federation, 115478
Moscow city oncology hospital #62 of Moscow Healthcare Department
Moscow, Russian Federation, 143423
State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary
Pyatigorsk, Russian Federation, 357502
Ryazan State Medical University Named after I.P.Pavlov
Ryazan, Russian Federation, 390011
SBI of Healthcare Samara Regional Clinical Oncology Dispensary
Samara, Russian Federation, 443031
SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
Stavropol, Russian Federation, 355045
Tula Regional Oncology Dispensary
Tula, Russian Federation, 300053
GUZ Vladimir Regional Clinical Oncological Dispensary
Vladimir, Russian Federation, 600009
Spain
Hospital General Universitario de Elche; Servicio de Oncologia
Elche, Alicante, Spain, 03203
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
Santiago de Compostela, LA Coruña, Spain, 15706
Hospital del Mar; Servicio de Oncologia
Barcelona, Spain, 08003
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, Spain, 08035
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
Jaen, Spain, 23007
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
La Coruña, Spain, 15006
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, Spain, 28007
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, Spain, 28041
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, Spain, 28046
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Malaga, Spain, 29010
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, Spain, 46010
Sweden
Uni Hospital Linkoeping; Dept. of Oncology
Linköping, Sweden, 58185
Skånes Universitetssjukhus; Kliniska Forskningsenheten Onkologimottagning medicinsk behandling
Malmö, Sweden, 205 02
Switzerland
Kantonsspital Baden; Medizinische Klinik, Onkologie
Baden, Switzerland, 5404
Universitaetsspital Basel; Onkologie
Basel, Switzerland, 4031
Kantonsspital Graubünden;Onkologie und Hämatologie
Chur, Switzerland, 7000
Taiwan
Changhua Christian Hospital; Hematology-Oncology
Changhua, Taiwan, 500
Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery
Kaohsiung, Taiwan, 807
National Taiwan Uni Hospital; Dept of Oncology
Taipei, Taiwan, 100
Tri-Service General Hospital; Hematology and Oncology
Taipei, Taiwan, 114
Thailand
National Cancer Inst.
Bangkok, Thailand, 10400
Rajavithi Hospital; Division of Medical Oncology
Bangkok, Thailand, 10400
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
Bangkok, Thailand, 10400
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok, Thailand, 10700
Maharaj Nakorn Hospital; Internal Medicine
Chiang Mai, Thailand, 50200
Prince of Songkla Uni ; Unit of Medical Oncology
Songkhla, Thailand, 90110
Turkey
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
Adana, Turkey, 01250
Cukurova Uni Faculty of Medicine; Medical Oncology
Adana, Turkey, 01330
Gazi Uni Medical Faculty Hospital; Oncology Dept
Ankara, Turkey, 06500
Ege Uni Medical Faculty Hospital; Oncology Dept
Izmir, Turkey, 35100
United Kingdom
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit
Glasgow, United Kingdom, G12 0YN
Leicester Royal Infirmary; Dept. of Medical Oncology
Leicester, United Kingdom, LE1 5WW
Royal Free Hospital; Dept of Oncology
London, United Kingdom, NW3 2QG
Guys Hospital; Management Offices
London, United Kingdom, SE1 9RT
Royal Marsden Hospital; Dept of Med-Onc
London, United Kingdom, SW3 6JJ
Christie Hospital; Breast Cancer Research Office
Manchester, United Kingdom, M20 4QL
Nottingham City Hospital; Oncology
Nottingham, United Kingdom, NG5 1PB
Peterborough City Hospital; Oncology Ward
Peterborough, United Kingdom, PE 3 9GZ
Queen Alexandra Hospital, Portsmouth
Portsmouth, United Kingdom, PO6 3LY
Weston Park Hospital; Cancer Clinical Trials Centre
Sheffield, United Kingdom, S10 2SJ
Southampton General Hospital; Somers Cancer Research Building
Southampton, United Kingdom, SO16 6YD
Uni Hospital of North Staffordshire; Staffordshire Oncology Centre
Stoke-on-Trent, United Kingdom, ST4 6QG
Royal Marsden Hospital; Dept of Medical Oncology
Sutton, United Kingdom, SM2 5PT
Royal Cornwall Hospital; Dept of Clinical Oncology
Truro, United Kingdom, TR1 3LJ
Sponsors and Collaborators
Hoffmann-La Roche
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01120184     History of Changes
Other Study ID Numbers: BO22589
2009-017905-13 ( EudraCT Number )
First Submitted: April 28, 2010
First Posted: May 10, 2010
Results First Submitted: May 2, 2016
Results First Posted: February 23, 2017
Last Update Posted: November 7, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Maytansine
Docetaxel
Ado-trastuzumab emtansine
Pertuzumab
Taxane
Albumin-Bound Paclitaxel
Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action