MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients (HERMIONE)

January 4, 2017 updated by: 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MM-302 + trastuzumab
Drug: Trastuzumab
Other Names:
  • Herceptin
Drug: MM-302
Active Comparator: Chemotherapy of Physician's Choice plus trastuzumab
Chemotherapy limited to one of the following: Gemcitabine, Capecitabine or Vinorelbine
Drug: Gemcitabine
Other Names:
  • Gemzar
Drug: Capecitabine
Other Names:
  • Xeloda
Drug: Trastuzumab
Other Names:
  • Herceptin
Drug: Vinorelbine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Independently assessed progression-free survival according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time Frame: Approximately 2 years
Approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Locally assessed progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time Frame: Approximately 2 years
Approximately 2 years
Overall Survival
Time Frame: Approximately 3 years
Approximately 3 years
Time to Treatment Failure
Time Frame: Approximately 2 years
Approximately 2 years
Objective Response Rate based on independent and investigator review of tumor assessments
Time Frame: Approximately 2 years
Approximately 2 years
Duration of Response (DoR) based on independent and investigator review of tumor assessments
Time Frame: Approximately 2 years
Approximately 2 years
Safety
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merrimack Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

August 6, 2014

First Submitted That Met QC Criteria

August 7, 2014

First Posted (Estimate)

August 11, 2014

Study Record Updates

Last Update Posted (Estimate)

January 6, 2017

Last Update Submitted That Met QC Criteria

January 4, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MM-302-02-02-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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