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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

113

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Belgien
      • Antwerp, Belgien
        • University Hospital Antwerp
      • Antwerp, Belgien
        • GZA Ziekenhuizen - campus Sint-Augustinus
      • Brussels, Belgien
        • Cliniques universitaires Saint-Luc
      • Liege, Belgien
        • Clinique Saint-Joseph
  • Canada
      • Edmonton, Canada
        • University of Alberta- Cross Cancer Institute
      • Quebec, Canada
        • McGill University Health Center
    • Ontario
      • London, Ontario, Canada
        • London Regional Cancer Center
      • Toronto, Ontario, Canada
        • Sunnybrook Health Sciences Centre
  • Forenede Stater
    • Arizona
      • Glendale, Arizona, Forenede Stater
        • Palo Verde Cancer Center
      • Scottsdale, Arizona, Forenede Stater
        • Mayo Clinic Cancer Center
      • Tucson, Arizona, Forenede Stater
        • University of Arizona Cancer Center
    • California
      • Fullerton, California, Forenede Stater
        • St. Jude Heritage Healthcare
      • La Jolla, California, Forenede Stater
        • UC San Diego Moores Cancer Center
      • Los Angeles, California, Forenede Stater
        • Ronald Reagan UCLA Medical Center
      • Redondo Beach, California, Forenede Stater
        • Cancer Care Associates Medical Group
      • San Francisco, California, Forenede Stater
        • UCSF Medical Center
      • Santa Barbara, California, Forenede Stater
        • Sansum Clinic
      • Vallejo, California, Forenede Stater
        • Kaiser Permanent Medical Center
    • Colorado
      • Aurora, Colorado, Forenede Stater
        • University of Colorado Cancer Center
      • Littleton, Colorado, Forenede Stater
        • Rocky Mountain Cancer Centers
    • Connecticut
      • New Haven, Connecticut, Forenede Stater
        • Smilow Cancer Hospital At Yale New Haven Hospital
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater
        • Washington Cancer Institute
    • Florida
      • Fort Meyers, Florida, Forenede Stater
        • Florida Cancer Specialists & Research Institute
      • Hollywood, Florida, Forenede Stater
        • Memorial Regional Hospital
      • Jacksonville, Florida, Forenede Stater
        • Mayo Clinic Cancer Center
      • New Port Richey, Florida, Forenede Stater
        • Sarah Cannon Research Institute
      • Orlando, Florida, Forenede Stater
        • UF Health Cancer Center at Orlando Health
      • Plantation, Florida, Forenede Stater
        • Florida Cancer Research Institute
      • Plantation, Florida, Forenede Stater
        • University of Miami Comprehensive Cancer Center
    • Georgia
      • Newnan, Georgia, Forenede Stater
        • Southeastern Regional Medical Center
    • Illinois
      • Chicago, Illinois, Forenede Stater
        • University of Chicago
      • Chicago, Illinois, Forenede Stater
        • Rush University Medical Center
      • Chicago, Illinois, Forenede Stater
        • Northwestern University- Robert H. Lurie Comprehensive Cancer Center
      • Joliet, Illinois, Forenede Stater
        • Joliet Oncology-Hematology Associates
      • Zion, Illinois, Forenede Stater
        • Midwestern Regional Medical Center
    • Indiana
      • Indianapolis, Indiana, Forenede Stater
        • Indiana University Melvin and Bren Simon Cancer Center
    • Iowa
      • Ames, Iowa, Forenede Stater
        • McFarland Clinic PC
    • Maryland
      • Baltimore, Maryland, Forenede Stater
        • Johns Hopkins Medicine- The Sidney Kimmel Comprehensive Cancer Center
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater
        • Dana-Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater
        • University of Michigan Health System
      • Ann Arbor, Michigan, Forenede Stater
        • St. Joseph Mercy Hospital
    • Minnesota
      • Coon Rapids, Minnesota, Forenede Stater
        • Minnesota Oncology Hematology
      • Minneapolis, Minnesota, Forenede Stater
        • University of Minnesota- Masonic Cancer Center
      • Rochester, Minnesota, Forenede Stater
        • Mayo Clinic Cancer Center
    • Missouri
      • Kansas City, Missouri, Forenede Stater
        • Saint Luke's Hospital
      • St. Louis, Missouri, Forenede Stater
        • Barnes-Jewish West County Hospital
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater
        • Hackensack University Medical Center
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater
        • New Mexico Cancer Care Alliance
    • New York
      • Albany, New York, Forenede Stater
        • New York Oncology Hematology, P.C.
      • Bronx, New York, Forenede Stater
        • Montefiore Medical Center
      • East Setauket, New York, Forenede Stater
        • North Shore Hematology Oncology Associates
      • New York, New York, Forenede Stater
        • NYU Langone Medical Center
      • New York, New York, Forenede Stater
        • Morton Coleman MD
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater
        • Office of Carey K. Anders
      • Durham, North Carolina, Forenede Stater
        • Duke Cancer Institute
    • Ohio
      • Cincinnati, Ohio, Forenede Stater
        • Oncology Hematology Care
      • Cleveland, Ohio, Forenede Stater
        • Cleveland Clinic
      • Columbus, Ohio, Forenede Stater
        • Ohio State University Hospital
    • Oregon
      • Bend, Oregon, Forenede Stater
        • St. Charles Health System
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater
        • Magee-Womens Hospital of UPMC
    • South Carolina
      • Greenville, South Carolina, Forenede Stater
        • Bon Secours Saint Francis Hospital Cancer Center
      • Greenville, South Carolina, Forenede Stater
        • Greenville Health System Cancer Institute
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater
        • Tennessee Oncology
      • Nashville, Tennessee, Forenede Stater
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, Forenede Stater
        • The Sarah Cannon Research Institute
    • Texas
      • Austin, Texas, Forenede Stater
        • Texas Oncology- Central Austin Cancer Center
      • Dallas, Texas, Forenede Stater
        • Texas Oncology - Baylor Charles A. Sammons Cancer Center
      • Dallas, Texas, Forenede Stater
        • Texas Oncology- Medical City
      • El Paso, Texas, Forenede Stater
        • Texas Oncology
      • Fort Worth, Texas, Forenede Stater
        • The Center for Cancer and Blood Disorders
      • Houston, Texas, Forenede Stater
        • Texas Oncology-Houston Memorial City
      • Houston, Texas, Forenede Stater
        • The University of Texas- MD Anderson Cancer Center
      • San Antonio, Texas, Forenede Stater
        • Cancer Care Centers of South Texas
      • Tyler, Texas, Forenede Stater
        • Texas Oncology
    • Utah
      • Salt Lake City, Utah, Forenede Stater
        • Huntsman Cancer Institute
    • Virginia
      • Norfolk, Virginia, Forenede Stater
        • Virginia Oncology Associate
    • Washington
      • Issaquah, Washington, Forenede Stater
        • Swedish Medical Center
      • Tacoma, Washington, Forenede Stater
        • Northwest Medical Specialties
  • Frankrig
      • Angers, Frankrig
        • Institut de Cancerologie de l'Ouest site Paul Papin
      • Lyon, Frankrig
        • Centre Leon Berard
      • Paris, Frankrig
        • Hopital de l'Institut Curie
      • Saint-Herblain, Frankrig
        • Institut de Cancérologie de l'Ouest
      • Toulouse, Frankrig
        • Institut Claudius Regaud
  • Italien
      • Aviano, Italien
        • Centro Riferimento Oncologico, IRCCS, Istituto Nazionale Tumori
      • Bologna, Italien
        • Azienda Ospedaliero-Universitaria di Bologna
      • Cremina, Italien
        • Azienda Socio Sanitaria Territoriale di Cremona
      • Macerata, Italien
        • Oncology Unit Macerata Hospital
      • Milan, Italien
        • Istituto Europeo Di Oncologia
      • Napoli, Italien
        • Istituto Nazionale Tumori, IRCCS Fondazione G. Pascale
      • Padova, Italien
        • Instituto Oncologico Veneto IRCCS
      • Terni, Italien
        • Azienda Ospedaliero S. Maria di Terni
    • Milan
      • Rozzano, Milan, Italien
        • Istituto Clinico Humanitas
  • Spanien
      • Barcelona, Spanien
        • Hospital Universitario Vall d'Hebron
      • Cordoba, Spanien
        • Hospital Universitario Reina Sofia
      • Cáceres, Spanien
        • Hospital San Pedro de Alcantara
      • Lleida, Spanien
        • Hospital Universitario Arnau de Vilanova
      • Madrid, Spanien
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spanien
        • Hospital Clínico San Carlos
      • Madrid, Spanien
        • Hospital Universitario Ramon y Cajal
      • Palma de Mallorca, Spanien
        • H.U.Son Espases
      • Pamplona, Spanien
        • Hospital De Navarra
      • Sevilla, Spanien
        • Hospital Universitario Virgen De La Macarena
  • Tjekkiet
      • Prague, Tjekkiet
        • Motol University Hospital
  • Tyskland
      • Homburg, Tyskland
        • Universitätsklinikum des Saarlandes
      • Lubeck, Tyskland
        • Universitätsklinikum Schleswig-Holstein
      • Munich, Tyskland
        • Interdisziplinares Onkologisches Zentrum
  • Østrig
      • Innsbruck, Østrig
        • Medizinische Universitat Innsbruck
      • Linz, Østrig
        • AKh Allgemeines Krankenhaus der Stadt Linz
      • Wien, Østrig
        • Medical University of Vienna

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: MM-302 + trastuzumab
Medicin: Trastuzumab
Andre navne:
  • Herceptin
Medicin: MM-302
Aktiv komparator: Chemotherapy of Physician's Choice plus trastuzumab
Chemotherapy limited to one of the following: Gemcitabine, Capecitabine or Vinorelbine
Medicin: Gemcitabin
Andre navne:
  • Gemzar
Medicin: Capecitabin
Andre navne:
  • Xeloda
Medicin: Trastuzumab
Andre navne:
  • Herceptin
Medicin: Vinorelbin

Hvad måler undersøgelsen?

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

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
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
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

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Merrimack Pharmaceuticals

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2014

Primær færdiggørelse (Faktiske)

1. december 2016

Studieafslutning (Forventet)

1. juni 2017

Datoer for studieregistrering

Først indsendt

6. august 2014

Først indsendt, der opfyldte QC-kriterier

7. august 2014

Først opslået (Skøn)

11. august 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. januar 2017

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MM-302-02-02-03

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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