MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients (HERMIONE)
4. januar 2017 oppdatert av: Merrimack Pharmaceuticals
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
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.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
113
Fase
- Fase 2
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Antwerp, Belgia
- University Hospital Antwerp
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Antwerp, Belgia
- GZA Ziekenhuizen - Campus Sint-Augustinus
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Brussels, Belgia
- Cliniques universitaires Saint-Luc
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Liege, Belgia
- Clinique Saint-Joseph
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Edmonton, Canada
- University of Alberta- Cross Cancer Institute
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Quebec, Canada
- McGill University Health Center
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Ontario
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London, Ontario, Canada
- London Regional Cancer Center
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Toronto, Ontario, Canada
- Sunnybrook Health Sciences Centre
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Arizona
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Glendale, Arizona, Forente stater
- Palo Verde Cancer Center
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Scottsdale, Arizona, Forente stater
- Mayo Clinic Cancer Center
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Tucson, Arizona, Forente stater
- University of Arizona Cancer Center
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California
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Fullerton, California, Forente stater
- St. Jude Heritage Healthcare
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La Jolla, California, Forente stater
- UC San Diego Moores Cancer Center
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Los Angeles, California, Forente stater
- Ronald Reagan UCLA Medical Center
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Redondo Beach, California, Forente stater
- Cancer Care Associates Medical Group
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San Francisco, California, Forente stater
- UCSF Medical Center
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Santa Barbara, California, Forente stater
- Sansum Clinic
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Vallejo, California, Forente stater
- Kaiser Permanent Medical Center
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Colorado
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Aurora, Colorado, Forente stater
- University of Colorado Cancer Center
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Littleton, Colorado, Forente stater
- Rocky Mountain Cancer Centers
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Connecticut
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New Haven, Connecticut, Forente stater
- Smilow Cancer Hospital At Yale New Haven Hospital
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District of Columbia
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Washington, District of Columbia, Forente stater
- Washington Cancer Institute
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Florida
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Fort Meyers, Florida, Forente stater
- Florida Cancer Specialists & Research Institute
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Hollywood, Florida, Forente stater
- Memorial Regional Hospital
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Jacksonville, Florida, Forente stater
- Mayo Clinic Cancer Center
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New Port Richey, Florida, Forente stater
- Sarah Cannon Research Institute
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Orlando, Florida, Forente stater
- UF Health Cancer Center at Orlando Health
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Plantation, Florida, Forente stater
- Florida Cancer Research Institute
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Plantation, Florida, Forente stater
- University of Miami Comprehensive Cancer Center
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Georgia
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Newnan, Georgia, Forente stater
- Southeastern Regional Medical Center
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Illinois
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Chicago, Illinois, Forente stater
- University of Chicago
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Chicago, Illinois, Forente stater
- Rush University Medical Center
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Chicago, Illinois, Forente stater
- Northwestern University- Robert H. Lurie Comprehensive Cancer Center
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Joliet, Illinois, Forente stater
- Joliet Oncology-Hematology Associates
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Zion, Illinois, Forente stater
- Midwestern Regional Medical Center
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Indiana
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Indianapolis, Indiana, Forente stater
- Indiana University Melvin and Bren Simon Cancer Center
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Iowa
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Ames, Iowa, Forente stater
- McFarland Clinic PC
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Maryland
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Baltimore, Maryland, Forente stater
- Johns Hopkins Medicine- The Sidney Kimmel Comprehensive Cancer Center
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Massachusetts
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Boston, Massachusetts, Forente stater
- Dana-Farber Cancer Institute
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Michigan
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Ann Arbor, Michigan, Forente stater
- University of Michigan Health System
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Ann Arbor, Michigan, Forente stater
- St. Joseph Mercy Hospital
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Minnesota
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Coon Rapids, Minnesota, Forente stater
- Minnesota Oncology Hematology
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Minneapolis, Minnesota, Forente stater
- University of Minnesota- Masonic Cancer Center
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Rochester, Minnesota, Forente stater
- Mayo Clinic Cancer Center
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Missouri
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Kansas City, Missouri, Forente stater
- Saint Luke's Hospital
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St. Louis, Missouri, Forente stater
- Barnes-Jewish West County Hospital
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New Jersey
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Hackensack, New Jersey, Forente stater
- Hackensack University Medical Center
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New Mexico
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Albuquerque, New Mexico, Forente stater
- New Mexico Cancer Care Alliance
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New York
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Albany, New York, Forente stater
- New York Oncology Hematology, P.C.
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Bronx, New York, Forente stater
- Montefiore Medical Center
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East Setauket, New York, Forente stater
- North Shore Hematology Oncology Associates
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New York, New York, Forente stater
- NYU Langone Medical Center
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New York, New York, Forente stater
- Morton Coleman MD
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North Carolina
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Chapel Hill, North Carolina, Forente stater
- Office of Carey K. Anders
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Durham, North Carolina, Forente stater
- Duke Cancer Institute
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Ohio
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Cincinnati, Ohio, Forente stater
- Oncology Hematology Care
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Cleveland, Ohio, Forente stater
- Cleveland Clinic
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Columbus, Ohio, Forente stater
- Ohio State University Hospital
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Oregon
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Bend, Oregon, Forente stater
- St. Charles Health System
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater
- Magee-Womens Hospital of UPMC
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South Carolina
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Greenville, South Carolina, Forente stater
- Bon Secours Saint Francis Hospital Cancer Center
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Greenville, South Carolina, Forente stater
- Greenville Health System Cancer Institute
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Tennessee
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Chattanooga, Tennessee, Forente stater
- Tennessee Oncology
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Nashville, Tennessee, Forente stater
- Vanderbilt University Medical Center
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Nashville, Tennessee, Forente stater
- The Sarah Cannon Research Institute
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Texas
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Austin, Texas, Forente stater
- Texas Oncology- Central Austin Cancer Center
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Dallas, Texas, Forente stater
- Texas Oncology - Baylor Charles A. Sammons Cancer Center
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Dallas, Texas, Forente stater
- Texas Oncology- Medical City
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El Paso, Texas, Forente stater
- Texas Oncology
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Fort Worth, Texas, Forente stater
- The Center for Cancer and Blood Disorders
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Houston, Texas, Forente stater
- Texas Oncology-Houston Memorial City
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Houston, Texas, Forente stater
- The University of Texas- MD Anderson Cancer Center
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San Antonio, Texas, Forente stater
- Cancer Care Centers of South Texas
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Tyler, Texas, Forente stater
- Texas Oncology
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Utah
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Salt Lake City, Utah, Forente stater
- Huntsman Cancer Institute
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Virginia
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Norfolk, Virginia, Forente stater
- Virginia Oncology Associate
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Washington
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Issaquah, Washington, Forente stater
- Swedish Medical Center
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Tacoma, Washington, Forente stater
- Northwest Medical Specialties
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Angers, Frankrike
- Institut de Cancerologie de l'Ouest site Paul Papin
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Lyon, Frankrike
- Centre Léon Bérard
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Paris, Frankrike
- Hopital de l'Institut Curie
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Saint-Herblain, Frankrike
- Institut de Cancérologie de l'Ouest
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Toulouse, Frankrike
- Institut Claudius Regaud
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Aviano, Italia
- Centro Riferimento Oncologico, IRCCS, Istituto Nazionale Tumori
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Bologna, Italia
- Azienda ospedaliero-universitaria di Bologna
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Cremina, Italia
- Azienda Socio Sanitaria Territoriale di Cremona
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Macerata, Italia
- Oncology Unit Macerata Hospital
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Milan, Italia
- Istituto Europeo di Oncologia
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Napoli, Italia
- Istituto Nazionale Tumori, IRCCS Fondazione G. Pascale
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Padova, Italia
- Instituto Oncologico Veneto IRCCS
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Terni, Italia
- Azienda Ospedaliero S. Maria di Terni
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Milan
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Rozzano, Milan, Italia
- Istituto Clinico Humanitas
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Barcelona, Spania
- Hospital Universitario Vall d'Hebron
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Cordoba, Spania
- Hospital Universitario Reina Sofia
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Cáceres, Spania
- Hospital San Pedro De Alcantara
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Lleida, Spania
- Hospital Universitario Arnau de Vilanova
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Madrid, Spania
- Hospital General Universitario Gregorio Marañón
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Madrid, Spania
- Hospital Clinico San Carlos
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Madrid, Spania
- Hospital Universitario Ramon y Cajal
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Palma de Mallorca, Spania
- H.U.Son Espases
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Pamplona, Spania
- Hospital de Navarra
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Sevilla, Spania
- Hospital Universitario Virgen De La Macarena
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Prague, Tsjekkisk Republikk
- Motol University Hospital
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Homburg, Tyskland
- Universitatsklinikum des Saarlandes
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Lubeck, Tyskland
- Universitatsklinikum Schleswig-Holstein
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Munich, Tyskland
- Interdisziplinares Onkologisches Zentrum
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Innsbruck, Østerrike
- Medizinische Universität Innsbruck
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Linz, Østerrike
- AKh Allgemeines Krankenhaus der Stadt Linz
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Wien, Østerrike
- Medical University of Vienna
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: MM-302 + trastuzumab
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Andre navn:
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Aktiv komparator: Chemotherapy of Physician's Choice plus trastuzumab
Chemotherapy limited to one of the following: Gemcitabine, Capecitabine or Vinorelbine
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Andre navn:
Andre navn:
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Independently assessed progression-free survival according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Tidsramme: Approximately 2 years
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Approximately 2 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Locally assessed progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Tidsramme: Approximately 2 years
|
Approximately 2 years
|
|
|
Overall Survival
Tidsramme: Approximately 3 years
|
Approximately 3 years
|
|
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Time to Treatment Failure
Tidsramme: Approximately 2 years
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Approximately 2 years
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Objective Response Rate based on independent and investigator review of tumor assessments
Tidsramme: Approximately 2 years
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Approximately 2 years
|
|
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Duration of Response (DoR) based on independent and investigator review of tumor assessments
Tidsramme: Approximately 2 years
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Approximately 2 years
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Safety
Tidsramme: Approximately 2 years
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We will look specifically at the Number of Participants with Adverse Events related to MM-302 as compared to the control arm
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Approximately 2 years
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Pharmacokinetic exposure of MM-302
Tidsramme: Approximately 2 years
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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.
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Approximately 2 years
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 2014
Primær fullføring (Faktiske)
1. desember 2016
Studiet fullført (Forventet)
1. juni 2017
Datoer for studieregistrering
Først innsendt
6. august 2014
Først innsendt som oppfylte QC-kriteriene
7. august 2014
Først lagt ut (Anslag)
11. august 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
6. januar 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. januar 2017
Sist bekreftet
1. januar 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Hudsykdommer
- Neoplasmer
- Neoplasmer etter nettsted
- Bryst sykdommer
- Brystneoplasmer
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Enzymhemmere
- Antimetabolitter, antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Tubulin modulatorer
- Antimitotiske midler
- Mitosemodulatorer
- Antineoplastiske midler, fytogene
- Antineoplastiske midler, immunologiske
- Gemcitabin
- Trastuzumab
- Capecitabin
- Vinorelbin
Andre studie-ID-numre
- MM-302-02-02-03
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .