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Clinical trial

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

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Last updated:31st Jul 2010
Identifier: NCT01120184

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.

Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 1095 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, 3 Arm, Multicenter, Phase III Study to Evaluate the Efficacy and the Safety of T-DM1 Combined With Pertuzumab or T-DM1 Combined With Pertuzumab-Placebo (Blinded for Pertuzumab), Versus the Combination of Trastuzumab Plus Taxane, as First Line Treatment in HER2 Positive Progressive or Recurrent Locally Advanced or Metastatic Breast Cancer
Actual Study Start Date: July 31, 2010
Actual Primary Completion Date: September 30, 2014
Actual Study Completion Date: September 16, 2016

- Experimental:
Trastuzumab + Taxane (docetaxel or paclitaxel)
- Experimental: Trastuzumab emtansine + pertuzumab
- Experimental: Trastuzumab emtansine + pertuzumab placebo

Category Value
Date last updated at source 2017-11-07
Study type(s) Interventional
Expected enrolment 1095
Study start date 2010-07-31
Estimated primary completion date 2014-09-30

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