Clareo Health | MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merrimack Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
