A RANDOMIZED ,3 ARM, MULTICENTRE, PHASE III STUDY TO EVALUATE THE EFFICACY AND SAFETY OF T-DM1 COMBINED WITH PERTUZUMAD OR T-DM1 COMBINED WITH PERTUZUMAB-PLACEBO (BLINDED FOR PERTUZUMAB) VERSUS THE COMBINATION OF TRANSTUZUMAB PLUS TAXANE, AS FIRST LINE TREATMENT IN HER2-POSITIVE PROGRESSIVE OR RECURRENT LOCALLY ADVANCED OR METASTATIC BREAST CANCER (MBC)
- Conditions
- -C50 Malignant neoplasm of breastMalignant neoplasm of breastC50
- Registration Number
- PER-084-10
- Lead Sponsor
- F. HOFFMANN-LA ROCHE LTD.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 20
• 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
• 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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method