ClinicalTrials.gov record
Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01120184

Public ClinicalTrials.gov record NCT01120184. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 4, 2026, 9:52 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Study identification

NCT ID
NCT01120184
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Hoffmann-La Roche
Industry
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 30, 2010
Primary completion
Sep 29, 2014
Completion
Sep 15, 2016
Last update posted
Mar 3, 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 3, 2024 · Synced May 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01120184 live on ClinicalTrials.gov.

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