Study identifier: NCT01120184 Synced from ClinicalTrials.gov · August 05, 2026
● Completed

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

Condition: Breast Cancer  ·  Sponsor: Hoffmann-La Roche

PhasePhase 3
Planned participants1095
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

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No contact information is available for this study as per the public registry record.

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Locations (257)

Uni of Arkansas For Medical Sciences; Arkansas Cancer Research CenterLittle Rock, Arkansas, United States
Scripps Cancer CenterLa Jolla, California, United States
University of California; Moores Cancer CenterLa Jolla, California, United States
Clnc L Trials & Rsch Assoc-IncMontebello, California, United States
Southern California Kaiser PermanenteSan Diego, California, United States
Breastlink Medical Group IncSanta Ana, California, United States
Kaiser Permanente; Oncology Clinical TrialsVallejo, California, United States
Smilow Cancer Hospital at Yale New HavenNew Haven, Connecticut, United States
Innovative Medical Research of South FloridaAventura, Florida, United States
Northwest Oncology/ Hematology Assoc.Coral Springs, Florida, United States
Florida Cancer Specialists; SCRIFort Myers, Florida, United States
Mayo Clinic-JacksonvilleJacksonville, Florida, United States

+ 245 more locations — full list on the registry record.

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