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Brief Title: MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients
Official Title: A Randomized, Multicenter, Open Label Study of MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in Anthracycline Naive Patients With Locally Advanced/Metastatic HER2-Positive Breast Cancer
Study ID: NCT02213744
Brief Summary: This study is an open label, randomized, multicenter trial of MM-302 plus trastuzumab. The trial is designed to demonstrate whether MM-302 plus trastuzumab is more effective than the chemotherapy of physician's choice (CPC) plus trastuzumab in locally advanced/metastatic HER2-positive breast cancer patients. Patients may not have been previously treated with an anthracycline in any setting. Patients must have received prior treatment with trastuzumab in any setting, have either progressed or are intolerant to ado-trastuzumab emtansine in the metastatic or locally advanced setting, have either progressed or are intolerant to pertuzumab in the metastatic or locally advanced setting or had disease recurrence within 12 months of pertuzumab treatment in the neoadjuvant or adjuvant setting.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Palo Verde Cancer Center, Glendale, Arizona, United States
Mayo Clinic Cancer Center, Scottsdale, Arizona, United States
University of Arizona Cancer Center, Tucson, Arizona, United States
St. Jude Heritage Healthcare, Fullerton, California, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
Ronald Reagan UCLA Medical Center, Los Angeles, California, United States
Cancer Care Associates Medical Group, Redondo Beach, California, United States
UCSF Medical Center, San Francisco, California, United States
Sansum Clinic, Santa Barbara, California, United States
Kaiser Permanent Medical Center, Vallejo, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Rocky Mountain Cancer Centers, Littleton, Colorado, United States
Smilow Cancer Hospital at Yale New Haven Hospital, New Haven, Connecticut, United States
Washington Cancer Institute, Washington, District of Columbia, United States
Florida Cancer Specialists & Research Institute, Fort Meyers, Florida, United States
Memorial Regional Hospital, Hollywood, Florida, United States
Mayo Clinic Cancer Center, Jacksonville, Florida, United States
Sarah Cannon Research Institute, New Port Richey, Florida, United States
UF Health Cancer Center at Orlando Health, Orlando, Florida, United States
Florida Cancer Research Institute, Plantation, Florida, United States
University of Miami Comprehensive Cancer Center, Plantation, Florida, United States
Southeastern Regional Medical Center, Newnan, Georgia, United States
Northwestern University- Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
University of Chicago, Chicago, Illinois, United States
Joliet Oncology-Hematology Associates, Joliet, Illinois, United States
Midwestern Regional Medical Center, Zion, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
McFarland Clinic PC, Ames, Iowa, United States
Johns Hopkins Medicine- The Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
St. Joseph Mercy Hospital, Ann Arbor, Michigan, United States
University of Michigan Health System, Ann Arbor, Michigan, United States
Minnesota Oncology Hematology, Coon Rapids, Minnesota, United States
University of Minnesota- Masonic Cancer Center, Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
Saint Luke's Hospital, Kansas City, Missouri, United States
Barnes-Jewish West County Hospital, St. Louis, Missouri, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
New Mexico Cancer Care Alliance, Albuquerque, New Mexico, United States
New York Oncology Hematology, P.C., Albany, New York, United States
Montefiore Medical Center, Bronx, New York, United States
North Shore Hematology Oncology Associates, East Setauket, New York, United States
Morton Coleman MD, New York, New York, United States
NYU Langone Medical Center, New York, New York, United States
Office of Carey K. Anders, Chapel Hill, North Carolina, United States
Duke Cancer Institute, Durham, North Carolina, United States
Oncology Hematology Care, Cincinnati, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Ohio State University Hospital, Columbus, Ohio, United States
St. Charles Health System, Bend, Oregon, United States
Magee-Womens Hospital of UPMC, Pittsburgh, Pennsylvania, United States
Bon Secours Saint Francis Hospital Cancer Center, Greenville, South Carolina, United States
Greenville Health System Cancer Institute, Greenville, South Carolina, United States
Tennessee Oncology, Chattanooga, Tennessee, United States
The Sarah Cannon Research Institute, Nashville, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Texas Oncology- Central Austin Cancer Center, Austin, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Texas Oncology- Medical City, Dallas, Texas, United States
Texas Oncology, El Paso, Texas, United States
The Center for Cancer and Blood Disorders, Fort Worth, Texas, United States
Texas Oncology-Houston Memorial City, Houston, Texas, United States
The University of Texas- MD Anderson Cancer Center, Houston, Texas, United States
Cancer Care Centers of South Texas, San Antonio, Texas, United States
Texas Oncology, Tyler, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Virginia Oncology Associate, Norfolk, Virginia, United States
Swedish Medical Center, Issaquah, Washington, United States
Northwest Medical Specialties, Tacoma, Washington, United States
Medizinische Universitat Innsbruck, Innsbruck, , Austria
AKh Allgemeines Krankenhaus der Stadt Linz, Linz, , Austria
Medical University of Vienna, Wien, , Austria
GZA Ziekenhuizen - Campus Sint-Augustinus, Antwerp, , Belgium
University Hospital Antwerp, Antwerp, , Belgium
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
Clinique Saint-Joseph, Liege, , Belgium
London Regional Cancer Center, London, Ontario, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
University of Alberta- Cross Cancer Institute, Edmonton, , Canada
McGill University Health Center, Quebec, , Canada
Motol University Hospital, Prague, , Czech Republic
Institut de Cancerologie de l'Ouest site Paul Papin, Angers, , France
Centre Léon Bérard, Lyon, , France
Hopital de l'Institut Curie, Paris, , France
Institut de Cancerologie de l'Ouest, Saint-Herblain, , France
Institut Claudius Regaud, Toulouse, , France
Universitatsklinikum des Saarlandes, Homburg, , Germany
Universitätsklinikum Schleswig-Holstein, Lubeck, , Germany
Interdisziplinares Onkologisches Zentrum, Munich, , Germany
Istituto Clinico Humanitas, Rozzano, Milan, Italy
Centro Riferimento Oncologico, IRCCS, Istituto Nazionale Tumori, Aviano, , Italy
Azienda Ospedaliero-Universitaria di Bologna, Bologna, , Italy
Azienda Socio Sanitaria Territoriale di Cremona, Cremina, , Italy
Oncology Unit Macerata Hospital, Macerata, , Italy
Istituto Europeo di Oncologia, Milan, , Italy
Istituto Nazionale Tumori, IRCCS Fondazione G. Pascale, Napoli, , Italy
Instituto Oncologico Veneto IRCCS, Padova, , Italy
Azienda Ospedaliero S. Maria di Terni, Terni, , Italy
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital Universitario Reina Sofía, Cordoba, , Spain
Hospital San Pedro de Alcantara, Cáceres, , Spain
Hospital Universitario Arnau de Vilanova, Lleida, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
H.U.Son Espases, Palma de Mallorca, , Spain
Hospital de Navarra, Pamplona, , Spain
Hospital Universitario Virgen de la Macarena, Sevilla, , Spain