SHS_492295 ELLE CMAC 15083
A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment
The purpose of this study is to determine whether patients treated with margetuximab plus chemotherapy have longer progression free survival and overall survival than patients treated with trastuzumab plus chemotherapy. An evaluation of efficacy, as measured by progression-free survival (PFS) assessed by independent review and overall survival (OS), of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with advanced HER2+ breast cancer who have received prior treatment with trastuzumab, pertuzumab, and ado-trastuzumab emtansine in the neoadjuvant, adjuvant, or metastatic setting, and who have received at least one, and no more than two, lines of therapy in the metastatic setting.
•Histologically-proven metastatic or locally-advanced relapsed/refractory HER2+ breast cancer. Tumors may be estrogen receptor (ER)/progesterone receptor (PR) positive or negative.
•Prior treatment with pertuzumab, trastuzumab, and ado-trastuzumab emtansine in the neoadjuvant, adjuvant, or metastatic setting. Prior radiotherapy and hormonal therapies are allowed.
•Prior treatment for at least one, and no more than two, lines of therapy in the metastatic setting. Patients must have progressed on or following, the most recent line of therapy.
•Resolution of all chemotherapy or radiation-related toxicities to ≤ Grade 1
•Life expectancy ≥ 12 weeks
•Acceptable laboratory parameters
•Women of childbearing potential must have negative pregnancy test, and agree to use an effective form of contraception for the duration of study treatment and for 120 days after the last dose of study drug
•Known, untreated brain metastasis
•History of uncontrolled seizures
•Prior allogeneic bone marrow, stem-cell, or solid organ transplantation
•History of clinically significant cardiovascular disease
•Clinically significant pulmonary compromise, including a requirement for supplemental oxygen use
•Any condition that would be a contraindication to receiving trastuzumab as described in the approved local label or a condition that would prevent treatment with the protocol specified chemotherapies
Erin Ellis, M.D.