A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)
Completed · Phase 3 · Has a placebo group
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT01120184
- Run by
- Hoffmann-La Roche
- People needed
- 1095
- Starts
- 2010-07-31
- Expected to finish
- 2016-09-16
- Last updated by the study team
- 2024-03-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Scripps Cancer Center — La Jolla, California, United States
- University of California; Moores Cancer Center — La Jolla, California, United States
- Clnc L Trials & Rsch Assoc-Inc — Montebello, California, United States
- Southern California Kaiser Permanente — San Diego, California, United States
- Breastlink Medical Group Inc — Santa Ana, California, United States
- Kaiser Permanente; Oncology Clinical Trials — Vallejo, California, United States
- Smilow Cancer Hospital at Yale New Haven — New Haven, Connecticut, United States
- Innovative Medical Research of South Florida — Aventura, Florida, United States
- Northwest Oncology/ Hematology Assoc. — Coral Springs, Florida, United States
- Florida Cancer Specialists; SCRI — Fort Myers, Florida, United States
- Mayo Clinic-Jacksonville — Jacksonville, Florida, United States
- Uni of Miami School of Medicine; Sylvester Comprehensive Cancer Center — Miami, Florida, United States
- University Cancer & Blood Center, LLC; Research — Athens, Georgia, United States
- Cancer Research Center of Hawaii; Clinical Sciences — Honolulu, Hawaii, United States
- Mountain States Tumor Inst. — Boise, Idaho, United States
- Uni of Chicago — Chicago, Illinois, United States
- Decatur Memorial Hospital — Decatur, Illinois, United States
- Ingalls Memorial Hospital — Harvey, Illinois, United States
- Loyola University Med Center — Maywood, Illinois, United States
- Illinois Cancer Care — Peoria, Illinois, United States
- Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
- Horizon Oncology Research, Inc. — Lafayette, Indiana, United States
- James Graham Brown Cancer Center, University of Louisville — Louisville, Kentucky, United States
- New England Cancer Specialists — Scarborough, Maine, United States
- Uni of Arkansas For Medical Sciences; Arkansas Cancer Research Center — Little Rock, Arkansas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.