MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients (HERMIONE)
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
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Studiesteder
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Antwerp, Belgien
- University Hospital Antwerp
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Antwerp, Belgien
- GZA Ziekenhuizen - Campus Sint-Augustinus
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Brussels, Belgien
- Cliniques universitaires Saint-Luc
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Liege, Belgien
- 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, Forenede Stater
- Palo Verde Cancer Center
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Scottsdale, Arizona, Forenede Stater
- Mayo Clinic Cancer Center
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Tucson, Arizona, Forenede Stater
- University of Arizona Cancer Center
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California
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Fullerton, California, Forenede Stater
- St. Jude Heritage Healthcare
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La Jolla, California, Forenede Stater
- UC San Diego Moores Cancer Center
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Los Angeles, California, Forenede Stater
- Ronald Reagan UCLA Medical Center
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Redondo Beach, California, Forenede Stater
- Cancer Care Associates Medical Group
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San Francisco, California, Forenede Stater
- UCSF Medical Center
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Santa Barbara, California, Forenede Stater
- Sansum Clinic
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Vallejo, California, Forenede Stater
- Kaiser Permanent Medical Center
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Colorado
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Aurora, Colorado, Forenede Stater
- University of Colorado Cancer Center
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Littleton, Colorado, Forenede Stater
- Rocky Mountain Cancer Centers
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Connecticut
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New Haven, Connecticut, Forenede Stater
- Smilow Cancer Hospital At Yale New Haven Hospital
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District of Columbia
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Washington, District of Columbia, Forenede Stater
- Washington Cancer Institute
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Florida
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Fort Meyers, Florida, Forenede Stater
- Florida Cancer Specialists & Research Institute
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Hollywood, Florida, Forenede Stater
- Memorial Regional Hospital
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Jacksonville, Florida, Forenede Stater
- Mayo Clinic Cancer Center
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New Port Richey, Florida, Forenede Stater
- Sarah Cannon Research Institute
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Orlando, Florida, Forenede Stater
- UF Health Cancer Center at Orlando Health
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Plantation, Florida, Forenede Stater
- Florida Cancer Research Institute
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Plantation, Florida, Forenede Stater
- University of Miami Comprehensive Cancer Center
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Georgia
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Newnan, Georgia, Forenede Stater
- Southeastern Regional Medical Center
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Illinois
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Chicago, Illinois, Forenede Stater
- University of Chicago
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Chicago, Illinois, Forenede Stater
- Rush University Medical Center
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Chicago, Illinois, Forenede Stater
- Northwestern University- Robert H. Lurie Comprehensive Cancer Center
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Joliet, Illinois, Forenede Stater
- Joliet Oncology-Hematology Associates
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Zion, Illinois, Forenede Stater
- Midwestern Regional Medical Center
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Indiana
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Indianapolis, Indiana, Forenede Stater
- Indiana University Melvin and Bren Simon Cancer Center
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Iowa
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Ames, Iowa, Forenede Stater
- McFarland Clinic PC
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Maryland
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Baltimore, Maryland, Forenede Stater
- Johns Hopkins Medicine- The Sidney Kimmel Comprehensive Cancer Center
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Massachusetts
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Boston, Massachusetts, Forenede Stater
- Dana-Farber Cancer Institute
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Michigan
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Ann Arbor, Michigan, Forenede Stater
- University of Michigan Health System
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Ann Arbor, Michigan, Forenede Stater
- St. Joseph Mercy Hospital
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Minnesota
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Coon Rapids, Minnesota, Forenede Stater
- Minnesota Oncology Hematology
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Minneapolis, Minnesota, Forenede Stater
- University of Minnesota- Masonic Cancer Center
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Rochester, Minnesota, Forenede Stater
- Mayo Clinic Cancer Center
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Missouri
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Kansas City, Missouri, Forenede Stater
- Saint Luke's Hospital
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St. Louis, Missouri, Forenede Stater
- Barnes-Jewish West County Hospital
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New Jersey
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Hackensack, New Jersey, Forenede Stater
- Hackensack University Medical Center
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New Mexico
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Albuquerque, New Mexico, Forenede Stater
- New Mexico Cancer Care Alliance
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New York
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Albany, New York, Forenede Stater
- New York Oncology Hematology, P.C.
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Bronx, New York, Forenede Stater
- Montefiore Medical Center
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East Setauket, New York, Forenede Stater
- North Shore Hematology Oncology Associates
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New York, New York, Forenede Stater
- NYU Langone Medical Center
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New York, New York, Forenede Stater
- Morton Coleman MD
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater
- Office of Carey K. Anders
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Durham, North Carolina, Forenede Stater
- Duke Cancer Institute
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Ohio
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Cincinnati, Ohio, Forenede Stater
- Oncology Hematology Care
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Cleveland, Ohio, Forenede Stater
- Cleveland Clinic
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Columbus, Ohio, Forenede Stater
- Ohio State University Hospital
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Oregon
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Bend, Oregon, Forenede Stater
- St. Charles Health System
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater
- Magee-Womens Hospital of UPMC
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South Carolina
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Greenville, South Carolina, Forenede Stater
- Bon Secours Saint Francis Hospital Cancer Center
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Greenville, South Carolina, Forenede Stater
- Greenville Health System Cancer Institute
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Tennessee
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Chattanooga, Tennessee, Forenede Stater
- Tennessee Oncology
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Nashville, Tennessee, Forenede Stater
- Vanderbilt University Medical Center
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Nashville, Tennessee, Forenede Stater
- The Sarah Cannon Research Institute
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Texas
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Austin, Texas, Forenede Stater
- Texas Oncology- Central Austin Cancer Center
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Dallas, Texas, Forenede Stater
- Texas Oncology - Baylor Charles A. Sammons Cancer Center
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Dallas, Texas, Forenede Stater
- Texas Oncology- Medical City
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El Paso, Texas, Forenede Stater
- Texas Oncology
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Fort Worth, Texas, Forenede Stater
- The Center for Cancer and Blood Disorders
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Houston, Texas, Forenede Stater
- Texas Oncology-Houston Memorial City
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Houston, Texas, Forenede Stater
- The University of Texas- MD Anderson Cancer Center
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San Antonio, Texas, Forenede Stater
- Cancer Care Centers of South Texas
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Tyler, Texas, Forenede Stater
- Texas Oncology
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Utah
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Salt Lake City, Utah, Forenede Stater
- Huntsman Cancer Institute
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Virginia
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Norfolk, Virginia, Forenede Stater
- Virginia Oncology Associate
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Washington
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Issaquah, Washington, Forenede Stater
- Swedish Medical Center
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Tacoma, Washington, Forenede Stater
- Northwest Medical Specialties
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Angers, Frankrig
- Institut de Cancerologie de l'Ouest site Paul Papin
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Lyon, Frankrig
- Centre Léon Bérard
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Paris, Frankrig
- Hopital de l'Institut Curie
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Saint-Herblain, Frankrig
- Institut de Cancérologie de l'Ouest
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Toulouse, Frankrig
- Institut Claudius Regaud
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Aviano, Italien
- Centro Riferimento Oncologico, IRCCS, Istituto Nazionale Tumori
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Bologna, Italien
- Azienda ospedaliero-universitaria di Bologna
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Cremina, Italien
- Azienda Socio Sanitaria Territoriale di Cremona
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Macerata, Italien
- Oncology Unit Macerata Hospital
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Milan, Italien
- Istituto Europeo di Oncologia
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Napoli, Italien
- Istituto Nazionale Tumori, IRCCS Fondazione G. Pascale
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Padova, Italien
- Instituto Oncologico Veneto IRCCS
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Terni, Italien
- Azienda Ospedaliero S. Maria di Terni
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Milan
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Rozzano, Milan, Italien
- Istituto Clinico Humanitas
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Barcelona, Spanien
- Hospital Universitario Vall d'Hebron
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Cordoba, Spanien
- Hospital Universitario Reina Sofia
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Cáceres, Spanien
- Hospital San Pedro De Alcantara
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Lleida, Spanien
- Hospital Universitario Arnau de Vilanova
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Madrid, Spanien
- Hospital General Universitario Gregorio Marañón
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Madrid, Spanien
- Hospital Clinico San Carlos
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Madrid, Spanien
- Hospital Universitario Ramon y Cajal
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Palma de Mallorca, Spanien
- H.U.Son Espases
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Pamplona, Spanien
- Hospital de Navarra
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Sevilla, Spanien
- Hospital Universitario Virgen De La Macarena
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Prague, Tjekkiet
- 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, Østrig
- Medizinische Universität Innsbruck
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Linz, Østrig
- AKh Allgemeines Krankenhaus der Stadt Linz
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Wien, Østrig
- Medical University of Vienna
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: MM-302 + trastuzumab
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Andre navne:
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Aktiv komparator: Chemotherapy of Physician's Choice plus trastuzumab
Chemotherapy limited to one of the following: Gemcitabine, Capecitabine or Vinorelbine
|
Andre navne:
Andre navne:
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
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
|
Approximately 2 years
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
|
|
|
Time to Treatment Failure
Tidsramme: Approximately 2 years
|
Approximately 2 years
|
|
|
Objective Response Rate based on independent and investigator review of tumor assessments
Tidsramme: Approximately 2 years
|
Approximately 2 years
|
|
|
Duration of Response (DoR) based on independent and investigator review of tumor assessments
Tidsramme: Approximately 2 years
|
Approximately 2 years
|
|
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Safety
Tidsramme: 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
|
Approximately 2 years
|
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Pharmacokinetic exposure of MM-302
Tidsramme: 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.
|
Approximately 2 years
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Forventet)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Hudsygdomme
- Neoplasmer
- Neoplasmer efter sted
- Brystsygdomme
- Brystneoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Antineoplastiske midler, immunologiske
- Gemcitabin
- Trastuzumab
- Capecitabin
- Vinorelbin
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- MM-302-02-02-03
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