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

NCT02213744 | Terminated Phase 2

• 1 other identifier: MM-302-02-02-03
• Study Type: interventional
• Target: 113
• Locations: 9 countries
• Sites: 109

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.

Conditions

Breast Cancer; HER2 Positive Breast Cancer

Keywords

HER2-positive; HER2+; HER2; Locally Advanced Breast Cancer; Metastatic Breast Cancer; trastuzumab; Herceptin; pertuzumab; ado-trastuzumab emtansine; TDM-1; Perjeta; Kadcyla

Outcome Measures

Primary Outcomes (1)

• Independently assessed progression-free survival according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

  Approximately 2 years

Secondary Outcomes (7)

• 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

Study Arms (2)

MM-302 + trastuzumab

EXPERIMENTAL

MM-302 + trastuzumab

Drug: MM-302; Drug: Trastuzumab

Chemotherapy of Physician's Choice plus trastuzumab

ACTIVE COMPARATOR

Chemotherapy limited to one of the following: Gemcitabine, Capecitabine or Vinorelbine

Drug: Gemcitabine; Drug: Capecitabine; Drug: Vinorelbine; Drug: Trastuzumab

Interventions

MM-302 DRUG

MM-302 + trastuzumab

Gemcitabine DRUG

Also known as: Gemzar

Chemotherapy of Physician's Choice plus trastuzumab

Capecitabine DRUG

Also known as: Xeloda

Chemotherapy of Physician's Choice plus trastuzumab

Vinorelbine DRUG

Chemotherapy of Physician's Choice plus trastuzumab

Trastuzumab DRUG

Also known as: Herceptin

Chemotherapy of Physician's Choice plus trastuzumab; MM-302 + trastuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merrimack Pharmaceuticals: lead

Study Sites (109)

Palo Verde Cancer Center

Glendale, Arizona, United States

Location

Mayo Clinic Cancer Center

Scottsdale, Arizona, United States

Location

University of Arizona Cancer Center

Tucson, Arizona, United States

Location

St. Jude Heritage Healthcare

Fullerton, California, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, United States

Location

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Location

Cancer Care Associates Medical Group

Redondo Beach, California, United States

Location

UCSF Medical Center

San Francisco, California, United States

Location

Sansum Clinic

Santa Barbara, California, United States

Location

Kaiser Permanent Medical Center

Vallejo, California, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, United States

Location

Rocky Mountain Cancer Centers

Littleton, Colorado, United States

Location

Smilow Cancer Hospital at Yale New Haven Hospital

New Haven, Connecticut, United States

Location

Washington Cancer Institute

Washington D.C., District of Columbia, United States

Location

Florida Cancer Specialists & Research Institute

Fort Meyers, Florida, United States

Location

Memorial Regional Hospital

Hollywood, Florida, United States

Location

Mayo Clinic Cancer Center

Jacksonville, Florida, United States

Location

Sarah Cannon Research Institute

New Port Richey, Florida, United States

Location

UF Health Cancer Center at Orlando Health

Orlando, Florida, United States

Location

Florida Cancer Research Institute

Plantation, Florida, United States

Location

University of Miami Comprehensive Cancer Center

Plantation, Florida, United States

Location

Southeastern Regional Medical Center

Newnan, Georgia, United States

Location

Northwestern University- Robert H. Lurie Comprehensive Cancer Center

Chicago, Illinois, United States

Location

Rush University Medical Center

Chicago, Illinois, United States

Location

University of Chicago

Chicago, Illinois, United States

Location

Joliet Oncology-Hematology Associates

Joliet, Illinois, United States

Location

Midwestern Regional Medical Center

Zion, Illinois, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Location

McFarland Clinic PC

Ames, Iowa, United States

Location

Johns Hopkins Medicine- The Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Location

St. Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, United States

Location

Minnesota Oncology Hematology

Coon Rapids, Minnesota, United States

Location

University of Minnesota- Masonic Cancer Center

Minneapolis, Minnesota, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Location

Saint Luke's Hospital

Kansas City, Missouri, United States

Location

Barnes-Jewish West County Hospital

St Louis, Missouri, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, United States

Location

New Mexico Cancer Care Alliance

Albuquerque, New Mexico, United States

Location

New York Oncology Hematology, P.C.

Albany, New York, United States

Location

North Shore Hematology Oncology Associates

East Setauket, New York, United States

Location

Morton Coleman MD

New York, New York, United States

Location

NYU Langone Medical Center

New York, New York, United States

Location

Montefiore Medical Center

The Bronx, New York, United States

Location

Office of Carey K. Anders

Chapel Hill, North Carolina, United States

Location

Duke Cancer Institute

Durham, North Carolina, United States

Location

Oncology Hematology Care

Cincinnati, Ohio, United States

Location

Cleveland Clinic

Cleveland, Ohio, United States

Location

Ohio State University Hospital

Columbus, Ohio, United States

Location

St. Charles Health System

Bend, Oregon, United States

Location

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Location

Bon Secours Saint Francis Hospital Cancer Center

Greenville, South Carolina, United States

Location

Greenville Health System Cancer Institute

Greenville, South Carolina, United States

Location

Tennessee Oncology

Chattanooga, Tennessee, United States

Location

The Sarah Cannon Research Institute

Nashville, Tennessee, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Location

Texas Oncology- Central Austin Cancer Center

Austin, Texas, United States

Location

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

Location

Texas Oncology- Medical City

Dallas, Texas, United States

Location

Texas Oncology

El Paso, Texas, United States

Location

The Center for Cancer and Blood Disorders

Fort Worth, Texas, United States

Location

Texas Oncology-Houston Memorial City

Houston, Texas, United States

Location

The University of Texas- MD Anderson Cancer Center

Houston, Texas, United States

Location

Cancer Care Centers of South Texas

San Antonio, Texas, United States

Location

Texas Oncology

Tyler, Texas, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Location

Virginia Oncology Associate

Norfolk, Virginia, United States

Location

Swedish Medical Center

Issaquah, Washington, United States

Location

Northwest Medical Specialties

Tacoma, Washington, United States

Location

Medizinische Universitat Innsbruck

Innsbruck, Austria

Location

AKh Allgemeines Krankenhaus der Stadt Linz

Linz, Austria

Location

Medical University of Vienna

Vienna, Austria

Location

GZA Ziekenhuizen - Campus Sint-Augustinus

Antwerp, Belgium

Location

University Hospital Antwerp

Antwerp, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Location

Clinique Saint-Joseph

Liège, Belgium

Location

London Regional Cancer Center

London, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

University of Alberta- Cross Cancer Institute

Edmonton, Canada

Location

McGill University Health Center

Québec, Canada

Location

Motol University Hospital

Prague, Czechia

Location

Institut de Cancerologie de l'Ouest site Paul Papin

Angers, France

Location

Centre Léon Bérard

Lyon, France

Location

Hopital de l'Institut Curie

Paris, France

Location

Institut de Cancerologie de l'Ouest

Saint-Herblain, France

Location

Institut Claudius Regaud

Toulouse, France

Location

Universitatsklinikum des Saarlandes

Homburg, Germany

Location

Universitätsklinikum Schleswig-Holstein

Lübeck, Germany

Location

Interdisziplinares Onkologisches Zentrum

Munich, Germany

Location

Istituto Clinico Humanitas

Rozzano, Milan, Italy

Location

Centro Riferimento Oncologico, IRCCS, Istituto Nazionale Tumori

Aviano, Italy

Location

Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy

Location

Azienda Socio Sanitaria Territoriale di Cremona

Cremina, Italy

Location

Oncology Unit Macerata Hospital

Macerata, Italy

Location

Istituto Europeo di Oncologia

Milan, Italy

Location

Istituto Nazionale Tumori, IRCCS Fondazione G. Pascale

Napoli, Italy

Location

Instituto Oncologico Veneto IRCCS

Padua, Italy

Location

Azienda Ospedaliero S. Maria di Terni

Terni, Italy

Location

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Location

Hospital San Pedro de Alcantara

Cáceres, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, Spain

Location

Hospital Universitario Arnau de Vilanova

Lleida, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, Spain

Location

H.U.Son Espases

Palma de Mallorca, Spain

Location

Hospital de Navarra

Pamplona, Spain

Location

Hospital Universitario Virgen de la Macarena

Seville, Spain

Location

Related Publications (1)

• Miller K, Cortes J, Hurvitz SA, Krop IE, Tripathy D, Verma S, Riahi K, Reynolds JG, Wickham TJ, Molnar I, Yardley DA. HERMIONE: a randomized Phase 2 trial of MM-302 plus trastuzumab versus chemotherapy of physician's choice plus trastuzumab in patients with previously treated, anthracycline-naive, HER2-positive, locally advanced/metastatic breast cancer. BMC Cancer. 2016 Jun 3;16:352. doi: 10.1186/s12885-016-2385-z.

  PMID: 27259714 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

gancotamab; Gemcitabine; Capecitabine; Vinorelbine; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 11, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: January 6, 2017

Record last verified: 2017-01

Locations

IT (9); US (70); CZ (1); CA (4); ES (10); AU (3); DE (3); FR (5); BE (4)