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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)

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ClinicalTrials.gov Identifier: NCT02213744
Recruitment Status : Terminated (Felt not to show benefit over control per DMC and confirmed via futility analysis)
First Posted : August 11, 2014
Last Update Posted : January 6, 2017
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals

Study Description
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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
Breast Cancer HER2 Positive Breast Cancer Drug: MM-302 Drug: Gemcitabine Drug: Capecitabine Drug: Vinorelbine Drug: Trastuzumab Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : July 2014
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: MM-302 + trastuzumab
MM-302 + trastuzumab
 Drug: MM-302
Drug: Trastuzumab
Other Name: Herceptin
Active Comparator: Chemotherapy of Physician's Choice plus trastuzumab
Chemotherapy limited to one of the following: Gemcitabine, Capecitabine or Vinorelbine
 Drug: Gemcitabine
Other Name: Gemzar

Drug: Capecitabine
Other Name: Xeloda

Drug: Vinorelbine
Drug: Trastuzumab
Other Name: Herceptin


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

Secondary Outcome Measures :
  1. Locally assessed progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Approximately 2 years ]
  2. Overall Survival [ Time Frame: Approximately 3 years ]
  3. Time to Treatment Failure [ Time Frame: Approximately 2 years ]
  4. Objective Response Rate based on independent and investigator review of tumor assessments [ Time Frame: Approximately 2 years ]
  5. Duration of Response (DoR) based on independent and investigator review of tumor assessments [ Time Frame: Approximately 2 years ]
  6. 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

  7. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213744


Locations
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Sponsors and Collaborators
Merrimack Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02213744    
Other Study ID Numbers: MM-302-02-02-03
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: January 6, 2017
Last Verified: January 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:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Capecitabine
Trastuzumab
Vinorelbine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators