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

• Status: Completed
• Trial end date: 2016-09-16
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Collaborator: Genentech, Inc.
• Treatments: Ado-Trastuzumab Emtansine; Albumin-Bound Paclitaxel; Docetaxel; Maytansine; Paclitaxel; Pertuzumab; Taxane; Trastuzumab

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