None listed
Conditions
Interventions
Group 1 Type of group
Option 1: Docetaxel (75 mg / m ^ 2) every 3 weeks plus a dose of trastuzumab impregnation of 8 mg / kg IV for Cycle 1 and 6 mg / kg IV every 3 weeks for subsequent cycles.
Option 2: Paclitaxel (80 mg / m ^ 2) weekly plus a dose of trastuzumab impregnation of 4 mg / kg IV for Cycle I Day I and 2 mg / kg IV weekly for weeks 2 and 3 of Cycle I and weekly for all subsequent cycles
Group name:Group 3 Type of group
T-DMl (3.6 mg / kg every 3 weeks) plus placebo of
pertuzumab (840/420 mg)
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Age
18 Years to 90 Years
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name: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. Measure:Percentage of Participants With Death or Disease Progression According to Independent Review Facility (IRF) Assessment Timepoints: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 ; Outcome name: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. Measure:Progression-Free Survival (PFS) According to IRF Assessment Timepoints: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
| Measure | Time frame |
|---|---|
| Outcome name: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. Measure:Percentage of Participants Who Died Prior to Clinical Cutoff Timepoints: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) ; Outcome name: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. Measure:Overall Survival (OS) at Clinical Cutoff Timepoints: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) ; Outcome name: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. Measure:Percentage of Participants With Death or Disease Progression According to Investigator Assessment Timepoints: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) ; Outcome name: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 | — |
Countries
Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Hungaria, Italy, Peru, Portugal, Spain, Sweden, United Kindgdom
Contacts
Public ContactPatricia Matos
ROCHE FARMA (PERU) S.A.
Outcome results
None listed