Status:
TERMINATED
MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients
Lead Sponsor:
Merrimack Pharmaceuticals
Conditions:
Breast Cancer
HER2 Positive Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT02213744
Start Date
July 1 2014
End Date
June 1 2017
Last Update
January 6 2017
Active Locations (109)
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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