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

Stopped early · Phase 2/Phase 3

Conditions studied: Breast Cancer, HER2 Positive Breast Cancer

In brief

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.

Key facts

Study ID

NCT02213744

Run by

Merrimack Pharmaceuticals

People needed

113

Starts

2014-07-01

Expected to finish

2017-06-01

Last updated by the study team

2017-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic Cancer Center — Scottsdale, Arizona, United States
• University of Arizona Cancer Center — Tucson, Arizona, United States
• St. Jude Heritage Healthcare — Fullerton, California, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• Cancer Care Associates Medical Group — Redondo Beach, California, United States
• UCSF Medical Center — San Francisco, California, United States
• Sansum Clinic — Santa Barbara, California, United States
• Kaiser Permanent Medical Center — Vallejo, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• Rocky Mountain Cancer Centers — Littleton, Colorado, United States
• Smilow Cancer Hospital at Yale New Haven Hospital — New Haven, Connecticut, United States
• Washington Cancer Institute — Washington D.C., District of Columbia, United States
• Florida Cancer Specialists & Research Institute — Fort Meyers, Florida, United States
• Memorial Regional Hospital — Hollywood, Florida, United States
• Mayo Clinic Cancer Center — Jacksonville, Florida, United States
• Sarah Cannon Research Institute — New Port Richey, Florida, United States
• UF Health Cancer Center at Orlando Health — Orlando, Florida, United States
• Florida Cancer Research Institute — Plantation, Florida, United States
• University of Miami Comprehensive Cancer Center — Plantation, Florida, United States
• Southeastern Regional Medical Center — Newnan, Georgia, United States
• Northwestern University- Robert H. Lurie Comprehensive Cancer Center — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Palo Verde Cancer Center — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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