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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Merrimack Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02213744
First received: August 6, 2014
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

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 who have received prior treatment with trastuzumab in any setting and who have either progressed or are intolerant to each of pertuzumab and ado-trastuzumab emtansine in the metastatic or locally advanced setting. Patients must not have been previously treated with an anthracycline in any setting.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Merrimack Pharmaceuticals:

Primary Outcome Measures:
  • Independently assessed progression-free survival according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Locally assessed progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Time to Treatment Failure [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
  • Objective Response Rate based on independent and investigator review of tumor assessments [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
  • Duration of Response (DoR) based on independent and investigator review of tumor assessments [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: Approximately 2 years ] [ Designated as safety issue: Yes ]
    We will look specifically at the Number of Participants with Adverse Events related to MM-302 as compared to the control arm

  • Pharmacokinetic exposure of MM-302 [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 250
Study Start Date: July 2014
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02213744

Contacts
Contact: Kaveh Riahi 617-441-1074 kriahi@merrimackpharma.com

Locations
United States, Arizona
Recruiting
Glendale, Arizona, United States, 85301
Sponsors and Collaborators
Merrimack Pharmaceuticals
  More Information

No publications provided

Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02213744     History of Changes
Other Study ID Numbers: MM-302-02-02-03
Study First Received: August 6, 2014
Last Updated: August 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merrimack Pharmaceuticals:
Locally Advanced Breast Cancer
Metastatic Breast Cancer
HER2-positive
HER2+
HER2
trastuzumab
Herceptin
pertuzumab
ado-trastuzumab emtansine
TDM-1
Perjeta
Kadcyla

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Capecitabine
Trastuzumab
Vinorelbine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 16, 2014