MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients
NCT ID: NCT02213744
Last Updated: 2017-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
113 participants
INTERVENTIONAL
2014-07-31
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MM-302 + trastuzumab
MM-302 + trastuzumab
MM-302
Trastuzumab
Chemotherapy of Physician's Choice plus trastuzumab
Chemotherapy limited to one of the following: Gemcitabine, Capecitabine or Vinorelbine
Gemcitabine
Capecitabine
Vinorelbine
Trastuzumab
Interventions
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MM-302
Gemcitabine
Capecitabine
Vinorelbine
Trastuzumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have documented locally advanced/metastatic disease, defined by the investigator, which is not amenable to resection with curative intent.
* Patients must have HER2-positive breast cancer as defined by ASCO/CAP 2013 guidelines that is confirmed by a Sponsor-designated central laboratory
* Patients must have progressed on, or be intolerant to pertuzumab in the LABC/MBC setting or had disease recurrence within 12 months of pertuzumab treatment in the neoadjuvant or adjuvant setting.
* Patients must have progressed on, or be intolerant to ado-trastuzumab emtansine in the LABC/MBC setting
* Patients must have been previously treated with trastuzumab in any setting (which may have been previously administered with or without pertuzumab)
* ECOG Performance Status of 0 or 1
Exclusion Criteria
* Subjects with central nervous system (CNS) metastases, unless they have been treated and are stable without symptoms for 4 weeks after completion of treatment and must be off steroids for at least 4 weeks prior to enrollment
* Patients with any class of New York Heart Association (NYHA) CHF or heart failure with preserved ejection fraction (HFPEF)
* Patients with a history of known coronary artery disease or a myocardial infarction within the last 12 months
* Patients with a known history of serious cardiac arrhythmias requiring treatment (exception: controlled atrial fibrillation, paroxysmal supraventricular tachycardia)
* Patients who previously discontinued trastuzumab due to unacceptable cardiac toxicity
* Patients with a history of LVEF decline to below 50% during or after prior trastuzumab/lapatinib or other HER2 directed therapy.
18 Years
ALL
No
Sponsors
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Merrimack Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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 D.C., 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
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
Montefiore Medical Center
The Bronx, 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
Vienna, , Austria
GZA Ziekenhuizen - Campus Sint-Augustinus
Antwerp, , Belgium
University Hospital Antwerp
Antwerp, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Clinique Saint-Joseph
Liège, , 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
Québec, , Canada
Motol University Hospital
Prague, , Czechia
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
Lübeck, , 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
Padua, , Italy
Azienda Ospedaliero S. Maria di Terni
Terni, , Italy
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital San Pedro de Alcantara
Cáceres, , Spain
Hospital Universitario Reina Sofía
Córdoba, , 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
Seville, , Spain
Countries
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References
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Miller K, Cortes J, Hurvitz SA, Krop IE, Tripathy D, Verma S, Riahi K, Reynolds JG, Wickham TJ, Molnar I, Yardley DA. HERMIONE: a randomized Phase 2 trial of MM-302 plus trastuzumab versus chemotherapy of physician's choice plus trastuzumab in patients with previously treated, anthracycline-naive, HER2-positive, locally advanced/metastatic breast cancer. BMC Cancer. 2016 Jun 3;16:352. doi: 10.1186/s12885-016-2385-z.
Other Identifiers
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MM-302-02-02-03
Identifier Type: -
Identifier Source: org_study_id
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