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

Sponsor
Merrimack Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT02213744
Collaborator
(none)
113
Enrollment
109
Locations
2
Arms
35
Duration (Months)
1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
113 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Jul 1, 2014
Actual Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Jun 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: MM-302 + trastuzumab

MM-302 + trastuzumab

Drug: MM-302

Drug: Trastuzumab
Other Names:
  • Herceptin

    		•
    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: Vinorelbine

    Drug: Trastuzumab
    Other Names:
  • Herceptin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Independently assessed progression-free survival according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [Approximately 2 years]

    Secondary Outcome Measures

    1. Locally assessed progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [Approximately 2 years]

    2. Overall Survival [Approximately 3 years]

    3. Time to Treatment Failure [Approximately 2 years]

    4. Objective Response Rate based on independent and investigator review of tumor assessments [Approximately 2 years]

    5. Duration of Response (DoR) based on independent and investigator review of tumor assessments [Approximately 2 years]

    6. Safety [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

    7. Pharmacokinetic exposure of MM-302 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Palo Verde Cancer Center Glendale Arizona United States
    2 Mayo Clinic Cancer Center Scottsdale Arizona United States
    3 University of Arizona Cancer Center Tucson Arizona United States
    4 St. Jude Heritage Healthcare Fullerton California United States
    5 UC San Diego Moores Cancer Center La Jolla California United States
    6 Ronald Reagan UCLA Medical Center Los Angeles California United States
    7 Cancer Care Associates Medical Group Redondo Beach California United States
    8 UCSF Medical Center San Francisco California United States
    9 Sansum Clinic Santa Barbara California United States
    10 Kaiser Permanent Medical Center Vallejo California United States
    11 University of Colorado Cancer Center Aurora Colorado United States
    12 Rocky Mountain Cancer Centers Littleton Colorado United States
    13 Smilow Cancer Hospital at Yale New Haven Hospital New Haven Connecticut United States
    14 Washington Cancer Institute Washington District of Columbia United States
    15 Florida Cancer Specialists & Research Institute Fort Meyers Florida United States
    16 Memorial Regional Hospital Hollywood Florida United States
    17 Mayo Clinic Cancer Center Jacksonville Florida United States
    18 Sarah Cannon Research Institute New Port Richey Florida United States
    19 UF Health Cancer Center at Orlando Health Orlando Florida United States
    20 Florida Cancer Research Institute Plantation Florida United States
    21 University of Miami Comprehensive Cancer Center Plantation Florida United States
    22 Southeastern Regional Medical Center Newnan Georgia United States
    23 Northwestern University- Robert H. Lurie Comprehensive Cancer Center Chicago Illinois United States
    24 Rush University Medical Center Chicago Illinois United States
    25 University of Chicago Chicago Illinois United States
    26 Joliet Oncology-Hematology Associates Joliet Illinois United States
    27 Midwestern Regional Medical Center Zion Illinois United States
    28 Indiana University Melvin and Bren Simon Cancer Center Indianapolis Indiana United States
    29 McFarland Clinic PC Ames Iowa United States
    30 Johns Hopkins Medicine- The Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland United States
    31 Dana-Farber Cancer Institute Boston Massachusetts United States
    32 St. Joseph Mercy Hospital Ann Arbor Michigan United States
    33 University of Michigan Health System Ann Arbor Michigan United States
    34 Minnesota Oncology Hematology Coon Rapids Minnesota United States
    35 University of Minnesota- Masonic Cancer Center Minneapolis Minnesota United States
    36 Mayo Clinic Cancer Center Rochester Minnesota United States
    37 Saint Luke's Hospital Kansas City Missouri United States
    38 Barnes-Jewish West County Hospital St. Louis Missouri United States
    39 Hackensack University Medical Center Hackensack New Jersey United States
    40 New Mexico Cancer Care Alliance Albuquerque New Mexico United States
    41 New York Oncology Hematology, P.C. Albany New York United States
    42 Montefiore Medical Center Bronx New York United States
    43 North Shore Hematology Oncology Associates East Setauket New York United States
    44 Morton Coleman MD New York New York United States
    45 NYU Langone Medical Center New York New York United States
    46 Office of Carey K. Anders Chapel Hill North Carolina United States
    47 Duke Cancer Institute Durham North Carolina United States
    48 Oncology Hematology Care Cincinnati Ohio United States
    49 Cleveland Clinic Cleveland Ohio United States
    50 Ohio State University Hospital Columbus Ohio United States
    51 St. Charles Health System Bend Oregon United States
    52 Magee-Womens Hospital of UPMC Pittsburgh Pennsylvania United States
    53 Bon Secours Saint Francis Hospital Cancer Center Greenville South Carolina United States
    54 Greenville Health System Cancer Institute Greenville South Carolina United States
    55 Tennessee Oncology Chattanooga Tennessee United States
    56 The Sarah Cannon Research Institute Nashville Tennessee United States
    57 Vanderbilt University Medical Center Nashville Tennessee United States
    58 Texas Oncology- Central Austin Cancer Center Austin Texas United States
    59 Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas Texas United States
    60 Texas Oncology- Medical City Dallas Texas United States
    61 Texas Oncology El Paso Texas United States
    62 The Center for Cancer and Blood Disorders Fort Worth Texas United States
    63 Texas Oncology-Houston Memorial City Houston Texas United States
    64 The University of Texas- MD Anderson Cancer Center Houston Texas United States
    65 Cancer Care Centers of South Texas San Antonio Texas United States
    66 Texas Oncology Tyler Texas United States
    67 Huntsman Cancer Institute Salt Lake City Utah United States
    68 Virginia Oncology Associate Norfolk Virginia United States
    69 Swedish Medical Center Issaquah Washington United States
    70 Northwest Medical Specialties Tacoma Washington United States
    71 Medizinische Universitat Innsbruck Innsbruck Austria
    72 AKh Allgemeines Krankenhaus der Stadt Linz Linz Austria
    73 Medical University of Vienna Wien Austria
    74 GZA Ziekenhuizen - Campus Sint-Augustinus Antwerp Belgium
    75 University Hospital Antwerp Antwerp Belgium
    76 Cliniques Universitaires Saint-Luc Brussels Belgium
    77 Clinique Saint-Joseph Liege Belgium
    78 London Regional Cancer Center London Ontario Canada
    79 Sunnybrook Health Sciences Centre Toronto Ontario Canada
    80 University of Alberta- Cross Cancer Institute Edmonton Canada
    81 McGill University Health Center Quebec Canada
    82 Motol University Hospital Prague Czech Republic
    83 Institut de Cancerologie de l'Ouest site Paul Papin Angers France
    84 Centre Léon Bérard Lyon France
    85 Hopital de l'Institut Curie Paris France
    86 Institut de Cancerologie de l'Ouest Saint-Herblain France
    87 Institut Claudius Regaud Toulouse France
    88 Universitatsklinikum des Saarlandes Homburg Germany
    89 Universitätsklinikum Schleswig-Holstein Lubeck Germany
    90 Interdisziplinares Onkologisches Zentrum Munich Germany
    91 Istituto Clinico Humanitas Rozzano Milan Italy
    92 Centro Riferimento Oncologico, IRCCS, Istituto Nazionale Tumori Aviano Italy
    93 Azienda Ospedaliero-Universitaria di Bologna Bologna Italy
    94 Azienda Socio Sanitaria Territoriale di Cremona Cremina Italy
    95 Oncology Unit Macerata Hospital Macerata Italy
    96 Istituto Europeo di Oncologia Milan Italy
    97 Istituto Nazionale Tumori, IRCCS Fondazione G. Pascale Napoli Italy
    98 Instituto Oncologico Veneto IRCCS Padova Italy
    99 Azienda Ospedaliero S. Maria di Terni Terni Italy
    100 Hospital Universitario Vall d'Hebron Barcelona Spain
    101 Hospital Universitario Reina Sofía Cordoba Spain
    102 Hospital San Pedro de Alcantara Cáceres Spain
    103 Hospital Universitario Arnau de Vilanova Lleida Spain
    104 Hospital Clinico San Carlos Madrid Spain
    105 Hospital General Universitario Gregorio Marañón Madrid Spain
    106 Hospital Universitario Ramon y Cajal Madrid Spain
    107 H.U.Son Espases Palma de Mallorca Spain
    108 Hospital de Navarra Pamplona Spain
    109 Hospital Universitario Virgen de la Macarena Sevilla Spain

    Sponsors and Collaborators

    • Merrimack Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merrimack Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT02213744
    Other Study ID Numbers:
    • MM-302-02-02-03
    First Posted:
    Aug 11, 2014
    Last Update Posted:
    Jan 6, 2017
    Last Verified:
    Jan 1, 2017
    Keywords provided by Merrimack Pharmaceuticals
    HER2-positive
    HER2+
    HER2
    Locally Advanced Breast Cancer
    Metastatic Breast Cancer
    trastuzumab
    Herceptin
    pertuzumab
    ado-trastuzumab emtansine
    TDM-1
    Perjeta
    Kadcyla
    Additional relevant MeSH terms:
    Breast Neoplasms
    Gemcitabine
    Capecitabine
    Trastuzumab
    Vinorelbine

    Study Results

    No Results Posted as of Jan 6, 2017