SCCA Breast Cancer Clinical Trials

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