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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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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01120184
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,095 participants
Conditions and interventions
Conditions
Interventions
- docetaxel Drug
- paclitaxel Drug
- pertuzumab Drug
- pertuzumab-placebo Drug
- trastuzumab [Herceptin] Drug
- trastuzumab emtansine Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2010 (Actual)
- Primary completion
- Sep 30, 2014 (Actual)
- Completion
- Sep 16, 2016 (Actual)
- Last update posted
- Mar 4, 2024
2010 – 2016
United States locations
- U.S. sites
- 62
- U.S. states
- 30
- U.S. cities
- 58
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Uni of Arkansas For Medical Sciences; Arkansas Cancer Research Center | Little Rock | Arkansas | 72204 | — |
| Scripps Cancer Center | La Jolla | California | 92037 | — |
| University of California; Moores Cancer Center | La Jolla | California | 92093 | — |
| Clnc L Trials & Rsch Assoc-Inc | Montebello | California | 90640 | — |
| Southern California Kaiser Permanente | San Diego | California | 92108 | — |
| Breastlink Medical Group Inc | Santa Ana | California | 92705 | — |
| Kaiser Permanente; Oncology Clinical Trials | Vallejo | California | 94589 | — |
| Smilow Cancer Hospital at Yale New Haven | New Haven | Connecticut | 06510 | — |
| Innovative Medical Research of South Florida | Aventura | Florida | 33180 | — |
| Northwest Oncology/ Hematology Assoc. | Coral Springs | Florida | 33065-5701 | — |
| Florida Cancer Specialists; SCRI | Fort Myers | Florida | 33901 | — |
| Mayo Clinic-Jacksonville | Jacksonville | Florida | 32224 | — |
| Uni of Miami School of Medicine; Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | — |
| University Cancer & Blood Center, LLC; Research | Athens | Georgia | 30607 | — |
| Cancer Research Center of Hawaii; Clinical Sciences | Honolulu | Hawaii | 96813 | — |
| Mountain States Tumor Inst. | Boise | Idaho | 83712 | — |
| Uni of Chicago | Chicago | Illinois | 60637 | — |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | — |
| Ingalls Memorial Hospital | Harvey | Illinois | 60426 | — |
| Loyola University Med Center | Maywood | Illinois | 60153 | — |
| Illinois Cancer Care | Peoria | Illinois | 61615 | — |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | — |
| Horizon Oncology Research, Inc. | Lafayette | Indiana | 47905 | — |
| James Graham Brown Cancer Center, University of Louisville | Louisville | Kentucky | 40202 | — |
| New England Cancer Specialists | Scarborough | Maine | 04074 | — |
| Anne Arundel Health System Research Instit-Annapolis Oncology Ctr | Annapolis | Maryland | 21401 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Spectrum Health Grand Rapids | Grand Rapids | Michigan | 49503 | — |
| University of Minnesota. | Minneapolis | Minnesota | 55454 | — |
| Mayo Clinic Rochester | Rochester | Minnesota | 55902 | — |
| Mercy Clinic Cancer & Hematology | Springfield | Missouri | 65804 | — |
| St. John'S Mercy Medical Center; David C. Pratt Cancer Center | St Louis | Missouri | 63141 | — |
| Dartmouth Hitchcock Med Center | Lebanon | New Hampshire | 03756 | — |
| Hackensack Uni Medical Center; Northern Nj Cancer Center | Hackensack | New Jersey | 07601 | — |
| Cancer Inst. of New Jersey | New Brunswick | New Jersey | 08901 | — |
| San Juan Oncology Associates | Farmington | New Mexico | 87401 | — |
| Queens Medical Associates | Fresh Meadows | New York | 11366 | — |
| Queens Hospital Center | Jamaica | New York | 11432 | — |
| Arena Oncology Associates | Lake Success | New York | 11042 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Weill Medical College of Cornell Uni | New York | New York | 10065 | — |
| Carolinas Hem-Oncology Assoc | Charlotte | North Carolina | 28203 | — |
| Carolina Oncology Specialists, PA - Hickory | Hickory | North Carolina | 28602 | — |
| Marion L. Shepard Cancer Center | Washington | North Carolina | 27889 | — |
| Sanford Roger Maris Cancer Center | Fargo | North Dakota | 58102 | — |
| Oncology Hematology Care - SCRI | Cincinnati | Ohio | 45242 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Charleston Oncology, P .A | Charleston | South Carolina | 29414 | — |
| Medical University of SC (MUSC) | Charleston | South Carolina | 29425 | — |
| South Carolina Oncology Associates - SCRI | Columbia | South Carolina | 29210 | — |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | — |
| SCRI Tennessee Oncology Chattanooga | Chattanooga | Tennessee | 37404 | — |
| West Clinic | Germantown | Tennessee | 38138 | — |
| Tennessee Onc., PLLC - SCRI | Nashville | Tennessee | 37203 | — |
| Vanderbilt-Ingram Cancer Ctr | Nashville | Tennessee | 37232 | — |
| The Don & Sybil Harrington Cancer Center; Department of Clinical Research | Amarillo | Texas | 79106 | — |
| Uni of Texas Southwestern Medical Center | Dallas | Texas | 75390-9063 | — |
| Uni of Texas - Md Anderson Cancer Center; Dept of Breast Medical Oncology | Houston | Texas | 77030 | — |
| Northern Utah Associates | Ogden | Utah | 84403 | — |
| The Providence Regional Medical Center Everett | Everett | Washington | 98201 | — |
| University of Washington | Seattle | Washington | 98195 | — |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 195 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01120184, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 4, 2024 · Synced Nov 12, 2026
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