|Closed||Breast Cancer||Phase III||
This randomized, 3-arm, multicentre study will evaluate the efficacy and safety of trastuzumab-DM1 with pertuzumab or trastuzumab-DM1 (T-DM1) with pertuzumab-placebo, versus the combination of trastuzumab [Herceptin] plus taxane (docetaxel or paclitaxel) in patients with HER2-positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer. Patients 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.
- Adult patients >/=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. Patients with locally advanced disease must have recurrent or progressive disease, which must not be amenable to resection with curative intent.
- Patients must have measurable and/or non-measurable disease which must be evaluable per RECIST 1.1
- ECOG Performance Status 0 or 1
- Adequate organ function as determined by laboratory results
- History of prior (or any) chemotherapy for metastatic breast cancer
- 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 <21 days prior to randomization
- Prior trastuzumab-DM1 or pertuzumab therapy
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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