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

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

Details

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