MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients
- Conditions
- Breast CancerHER2 Positive Breast Cancer
- Interventions
- Registration Number
- NCT02213744
- Lead Sponsor
- Merrimack Pharmaceuticals
- 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
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 113
- Patients must have histologically or cytologically confirmed invasive cancer of the breast
- 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
- Patients who have previously been treated with doxorubicin, liposomal doxorubicin, epirubicin, mitoxantrone, or any other anthracycline derivative
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MM-302 + trastuzumab Trastuzumab MM-302 + trastuzumab MM-302 + trastuzumab MM-302 MM-302 + trastuzumab Chemotherapy of Physician's Choice plus trastuzumab Gemcitabine Chemotherapy limited to one of the following: Gemcitabine, Capecitabine or Vinorelbine Chemotherapy of Physician's Choice plus trastuzumab Capecitabine Chemotherapy limited to one of the following: Gemcitabine, Capecitabine or Vinorelbine Chemotherapy of Physician's Choice plus trastuzumab Vinorelbine Chemotherapy limited to one of the following: Gemcitabine, Capecitabine or Vinorelbine Chemotherapy of Physician's Choice plus trastuzumab Trastuzumab Chemotherapy limited to one of the following: Gemcitabine, Capecitabine or Vinorelbine
- Primary Outcome Measures
Name Time Method Independently assessed progression-free survival according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Approximately 2 years
- Secondary Outcome Measures
Name Time Method Locally assessed progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Approximately 2 years Overall Survival Approximately 3 years Time to Treatment Failure Approximately 2 years Objective Response Rate based on independent and investigator review of tumor assessments Approximately 2 years Duration of Response (DoR) based on independent and investigator review of tumor assessments Approximately 2 years Safety Approximately 2 years We will look specifically at the Number of Participants with Adverse Events related to MM-302 as compared to the control arm
Pharmacokinetic exposure of MM-302 Approximately 2 years Area Under Curve (AUC) Time Frame: Cycles 1 and 2 - pre-infusion, post-infusion, and 168 hours post-dose. An optional timepoint at 8-96 hours post infusion is included during both cycles as well.
Trial Locations
- Locations (106)
Tennessee Oncology
🇺🇸Chattanooga, Tennessee, United States
Texas Oncology- Medical City
🇺🇸Dallas, Texas, United States
Magee-Womens Hospital of UPMC
🇺🇸Pittsburgh, Pennsylvania, 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
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
University Hospital Antwerp
🇧🇪Antwerp, Belgium
Washington Cancer Institute
🇺🇸Washington, District of Columbia, United States
Sansum Clinic
🇺🇸Santa Barbara, California, United States
GZA Ziekenhuizen - Campus Sint-Augustinus
🇧🇪Antwerp, Belgium
University of Miami Comprehensive Cancer Center
🇺🇸Plantation, Florida, United States
Midwestern Regional Medical Center
🇺🇸Zion, Illinois, United States
Medical University of Vienna
🇦🇹Wien, Austria
University of Alberta- Cross Cancer Institute
🇨🇦Edmonton, Canada
Azienda Socio Sanitaria Territoriale di Cremona
🇮🇹Cremina, Italy
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital San Pedro de Alcantara
🇪🇸Cáceres, Spain
UCSF Medical Center
🇺🇸San Francisco, California, United States
Indiana University Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of Minnesota- Masonic Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Duke Cancer Institute
🇺🇸Durham, North Carolina, United States
Oncology Hematology Care
🇺🇸Cincinnati, Ohio, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
The Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Texas Oncology-Houston Memorial City
🇺🇸Houston, Texas, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Oncology Unit Macerata Hospital
🇮🇹Macerata, Italy
Istituto Europeo di Oncologia
🇮🇹Milan, Italy
Institut de Cancerologie de l'Ouest site Paul Papin
🇫🇷Angers, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Universitätsklinikum Schleswig-Holstein
🇩🇪Lubeck, Germany
University of Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
St. Jude Heritage Healthcare
🇺🇸Fullerton, California, United States
Ronald Reagan UCLA Medical Center
🇺🇸Los Angeles, California, United States
UC San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
Kaiser Permanent Medical Center
🇺🇸Vallejo, California, United States
Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
Sarah Cannon Research Institute
🇺🇸New Port Richey, Florida, United States
Florida Cancer Research Institute
🇺🇸Plantation, Florida, United States
Southeastern Regional Medical Center
🇺🇸Newnan, Georgia, United States
Johns Hopkins Medicine- The Sidney Kimmel Comprehensive Cancer Center
🇺🇸Baltimore, Maryland, United States
Barnes-Jewish West County Hospital
🇺🇸St. Louis, Missouri, United States
New Mexico Cancer Care Alliance
🇺🇸Albuquerque, New Mexico, United States
Morton Coleman MD
🇺🇸New York, New York, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
Ohio State University Hospital
🇺🇸Columbus, Ohio, United States
St. Charles Health System
🇺🇸Bend, Oregon, United States
Bon Secours Saint Francis Hospital Cancer Center
🇺🇸Greenville, South Carolina, United States
Greenville Health System Cancer Institute
🇺🇸Greenville, South Carolina, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Texas Oncology- Central Austin Cancer Center
🇺🇸Austin, Texas, United States
The Center for Cancer and Blood Disorders
🇺🇸Fort Worth, 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
Virginia Oncology Associate
🇺🇸Norfolk, Virginia, United States
Swedish Medical Center
🇺🇸Issaquah, Washington, United States
Medizinische Universitat Innsbruck
🇦🇹Innsbruck, Austria
AKh Allgemeines Krankenhaus der Stadt Linz
🇦🇹Linz, Austria
London Regional Cancer Center
🇨🇦London, Ontario, Canada
Clinique Saint-Joseph
🇧🇪Liege, Belgium
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
McGill University Health Center
🇨🇦Quebec, Canada
Hopital de l'Institut Curie
🇫🇷Paris, France
Motol University Hospital
🇨🇿Prague, Czech Republic
Centre Léon Bérard
🇫🇷Lyon, France
Institut de Cancerologie de l'Ouest
🇫🇷Saint-Herblain, France
Universitatsklinikum des Saarlandes
🇩🇪Homburg, Germany
Interdisziplinares Onkologisches Zentrum
🇩🇪Munich, Germany
Centro Riferimento Oncologico, IRCCS, Istituto Nazionale Tumori
🇮🇹Aviano, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano, Milan, Italy
Azienda Ospedaliero-Universitaria di Bologna
🇮🇹Bologna, Italy
Instituto Oncologico Veneto IRCCS
🇮🇹Padova, Italy
Istituto Nazionale Tumori, IRCCS Fondazione G. Pascale
🇮🇹Napoli, Italy
Hospital Universitario Reina SofÃa
🇪🇸Cordoba, Spain
Hospital Universitario Arnau de Vilanova
🇪🇸Lleida, Spain
Azienda Ospedaliero S. Maria di Terni
🇮🇹Terni, Italy
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Hospital de Navarra
🇪🇸Pamplona, Spain
Hospital Universitario Virgen de la Macarena
🇪🇸Sevilla, Spain
H.U.Son Espases
🇪🇸Palma de Mallorca, Spain
Florida Cancer Specialists & Research Institute
🇺🇸Fort Meyers, Florida, United States
Palo Verde Cancer Center
🇺🇸Glendale, Arizona, United States
Cancer Care Associates Medical Group
🇺🇸Redondo Beach, California, United States
McFarland Clinic PC
🇺🇸Ames, Iowa, United States
Joliet Oncology-Hematology Associates
🇺🇸Joliet, Illinois, United States
Minnesota Oncology Hematology
🇺🇸Coon Rapids, Minnesota, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
New York Oncology Hematology, P.C.
🇺🇸Albany, New York, United States
North Shore Hematology Oncology Associates
🇺🇸East Setauket, New York, United States
Texas Oncology
🇺🇸Tyler, Texas, United States
Northwest Medical Specialties
🇺🇸Tacoma, Washington, United States
Rocky Mountain Cancer Centers
🇺🇸Littleton, Colorado, United States
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
UF Health Cancer Center at Orlando Health
🇺🇸Orlando, Florida, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
Smilow Cancer Hospital at Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
St. Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Saint Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Office of Carey K. Anders
🇺🇸Chapel Hill, North Carolina, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States