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Breast CancerPhase 2/3HERMIONENCT02213744

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

A Phase 2/3 study testing MM-302, Gemcitabine and Capecitabine in people with Breast Cancer and HER2 Positive Breast Cancer, run by Merrimack Pharmaceuticals at 109 sites in 9 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, HER2 Positive Breast Cancer
What is being tested?
MM-302, Gemcitabine and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
113 participants
Where
109 sitesin 9 countries
Study dates
Jul 2014to Jun 2017
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

109 sites in 9 countries.

109 sites in 9 countries

United States70 sites

  • New York Oncology Hematology, P.C.

    Albany, New York

  • New Mexico Cancer Care Alliance

    Albuquerque, New Mexico

  • McFarland Clinic PC

    Ames, Iowa

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan

  • University of Michigan Health System

    Ann Arbor, Michigan

  • University of Colorado Cancer Center

    Aurora, Colorado

  • Texas Oncology- Central Austin Cancer Center

    Austin, Texas

  • Johns Hopkins Medicine- The Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland

  • St. Charles Health System

    Bend, Oregon

  • Dana-Farber Cancer Institute

    Boston, Massachusetts

  • Office of Carey K. Anders

    Chapel Hill, North Carolina

  • Tennessee Oncology

    Chattanooga, Tennessee

  • Northwestern University- Robert H. Lurie Comprehensive Cancer Center

    Chicago, Illinois

  • Rush University Medical Center

    Chicago, Illinois

  • University of Chicago

    Chicago, Illinois

  • Oncology Hematology Care

    Cincinnati, Ohio

  • Cleveland Clinic

    Cleveland, Ohio

  • Ohio State University Hospital

    Columbus, Ohio

  • Minnesota Oncology Hematology

    Coon Rapids, Minnesota

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas

  • Texas Oncology- Medical City

    Dallas, Texas

  • Duke Cancer Institute

    Durham, North Carolina

  • North Shore Hematology Oncology Associates

    East Setauket, New York

  • Texas Oncology

    El Paso, Texas

  • Florida Cancer Specialists & Research Institute

    Fort Meyers, Florida

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas

  • St. Jude Heritage Healthcare

    Fullerton, California

  • Palo Verde Cancer Center

    Glendale, Arizona

  • Bon Secours Saint Francis Hospital Cancer Center

    Greenville, South Carolina

  • Greenville Health System Cancer Institute

    Greenville, South Carolina

  • Hackensack University Medical Center

    Hackensack, New Jersey

  • Memorial Regional Hospital

    Hollywood, Florida

  • Texas Oncology-Houston Memorial City

    Houston, Texas

  • The University of Texas- MD Anderson Cancer Center

    Houston, Texas

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana

  • Swedish Medical Center

    Issaquah, Washington

  • Mayo Clinic Cancer Center

    Jacksonville, Florida

  • Joliet Oncology-Hematology Associates

    Joliet, Illinois

  • Saint Luke's Hospital

    Kansas City, Missouri

  • UC San Diego Moores Cancer Center

    La Jolla, California

  • Rocky Mountain Cancer Centers

    Littleton, Colorado

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California

  • University of Minnesota- Masonic Cancer Center

    Minneapolis, Minnesota

  • The Sarah Cannon Research Institute

    Nashville, Tennessee

  • Vanderbilt University Medical Center

    Nashville, Tennessee

  • Smilow Cancer Hospital at Yale New Haven Hospital

    New Haven, Connecticut

  • Sarah Cannon Research Institute

    New Port Richey, Florida

  • Morton Coleman MD

    New York, New York

  • NYU Langone Medical Center

    New York, New York

  • Southeastern Regional Medical Center

    Newnan, Georgia

  • Virginia Oncology Associate

    Norfolk, Virginia

  • UF Health Cancer Center at Orlando Health

    Orlando, Florida

  • Magee-Womens Hospital of UPMC

    Pittsburgh, Pennsylvania

  • Florida Cancer Research Institute

    Plantation, Florida

  • University of Miami Comprehensive Cancer Center

    Plantation, Florida

  • Cancer Care Associates Medical Group

    Redondo Beach, California

  • Mayo Clinic Cancer Center

    Rochester, Minnesota

  • Huntsman Cancer Institute

    Salt Lake City, Utah

  • Cancer Care Centers of South Texas

    San Antonio, Texas

  • UCSF Medical Center

    San Francisco, California

  • Sansum Clinic

    Santa Barbara, California

  • Mayo Clinic Cancer Center

    Scottsdale, Arizona

  • Barnes-Jewish West County Hospital

    St Louis, Missouri

  • Northwest Medical Specialties

    Tacoma, Washington

  • Montefiore Medical Center

    The Bronx, New York

  • University of Arizona Cancer Center

    Tucson, Arizona

  • Texas Oncology

    Tyler, Texas

  • Kaiser Permanent Medical Center

    Vallejo, California

  • Washington Cancer Institute

    Washington D.C., District of Columbia

  • Midwestern Regional Medical Center

    Zion, Illinois

Other trials in United States

Spain10 sites

  • Hospital Universitario Vall d'Hebron

    Barcelona

  • Hospital San Pedro de Alcantara

    Cáceres

  • Hospital Universitario Reina Sofía

    Córdoba

  • Hospital Universitario Arnau de Vilanova

    Lleida

  • Hospital Clinico San Carlos

    Madrid

  • Hospital General Universitario Gregorio Marañón

    Madrid

  • Hospital Universitario Ramon y Cajal

    Madrid

  • H.U.Son Espases

    Palma de Mallorca

  • Hospital de Navarra

    Pamplona

  • Hospital Universitario Virgen de la Macarena

    Seville

Other trials in Spain

Italy9 sites

  • Centro Riferimento Oncologico, IRCCS, Istituto Nazionale Tumori

    Aviano

  • Azienda Ospedaliero-Universitaria di Bologna

    Bologna

  • Azienda Socio Sanitaria Territoriale di Cremona

    Cremina

  • Istituto Europeo di Oncologia

    Milan

  • Istituto Nazionale Tumori, IRCCS Fondazione G. Pascale

    Naples

  • Instituto Oncologico Veneto IRCCS

    Padova

  • Oncology Unit Macerata Hospital

    Province of Macerata

  • Istituto Clinico Humanitas

    Rozzano, Milan

  • Azienda Ospedaliero S. Maria di Terni

    Terni

Other trials in Italy

France5 sites

  • Institut de Cancerologie de l'Ouest site Paul Papin

    Angers

  • Centre Léon Bérard

    Lyon

  • Hopital de l'Institut Curie

    Paris

  • Institut de Cancerologie de l'Ouest

    Saint-Herblain

  • Institut Claudius Regaud

    Toulouse

Other trials in France

Belgium4 sites

  • GZA Ziekenhuizen - Campus Sint-Augustinus

    Antwerp

  • University Hospital Antwerp

    Antwerp

  • Cliniques Universitaires Saint-Luc

    Brussels

  • Clinique Saint-Joseph

    Liège

Other trials in Belgium

Canada4 sites

  • University of Alberta- Cross Cancer Institute

    Edmonton

  • London Regional Cancer Center

    London, Ontario

  • McGill University Health Center

    Québec

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario

Other trials in Canada

Austria3 sites

  • Medizinische Universitat Innsbruck

    Innsbruck

  • AKh Allgemeines Krankenhaus der Stadt Linz

    Linz

  • Medical University of Vienna

    Vienna

Other trials in Austria

Germany3 sites

  • Universitatsklinikum des Saarlandes

    Homburg

  • Universitätsklinikum Schleswig-Holstein

    Lübeck

  • Interdisziplinares Onkologisches Zentrum

    Munich

Other trials in Germany

Czechia1 site

  • Motol University Hospital

    Prague

Other trials in Czechia

About this study

Official title: 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.

Keywords
HER2-positive, HER2+, HER2, Locally Advanced Breast Cancer, Metastatic Breast Cancer, trastuzumab, Herceptin, pertuzumab, ado-trastuzumab emtansine, TDM-1, Perjeta, Kadcyla
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02213744
Study groupRoleWhat they receive
MM-302 + trastuzumabExperimentalMM-302 + trastuzumab
Receives: Drug: MM-302; Drug: Trastuzumab
Chemotherapy of Physician's Choice plus trastuzumabActive comparatorChemotherapy limited to one of the following: Gemcitabine, Capecitabine or Vinorelbine
Receives: Drug: Gemcitabine; Drug: Capecitabine; Drug: Vinorelbine; Drug: Trastuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Approximately 2 years

Secondary outcomes (7)

  1. Locally assessed progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    Measured: Approximately 2 years

  2. Overall Survival

    Measured: Approximately 3 years

  3. Time to Treatment Failure

    Measured: Approximately 2 years

  4. Objective Response Rate based on independent and investigator review of tumor assessments

    Measured: Approximately 2 years

  5. Duration of Response (DoR) based on independent and investigator review of tumor assessments

    Measured: Approximately 2 years

  6. Safety

    We will look specifically at the Number of Participants with Adverse Events related to MM-302 as compared to the control arm

    Measured: Approximately 2 years

  7. Pharmacokinetic exposure of MM-302

    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.

    Measured: Approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionDec 2016
  4. Study completionJun 2017 (estimated)

Why it stopped: Felt not to show benefit over control per DMC and confirmed via futility analysis

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02213744
Sponsor's protocol ID
MM-302-02-02-03
Acronym
HERMIONE
Status last verified
Jan 2017
First submitted
6 Aug 2014
Last updated
6 Jan 2017
Results posted
No

Publications

  • 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.

    PubMed 27259714

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing MM-302, Gemcitabine and Capecitabine in people with Breast Cancer and HER2 Positive Breast Cancer, run by Merrimack Pharmaceuticals at 109 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 109 sites in United States, Spain, Italy, France, Belgium and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Felt not to show benefit over control per DMC and confirmed via futility analysis). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Independently assessed progression-free survival according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (time frame: Approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02213744, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2017.

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