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
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 with metastatic breast cancer treated with margetuximab plus chemotherapy have longer progression free survival (PFS) and overall survival (OS) than patients treated with trastuzumab plus chemotherapy.
A non-randomized sub-study cohort of approximately 88 patients will be enrolled to evaluate the safety of a reduced margetuximab infusion rate in patients receiving margetuximab either as monotherapy or in combination with chemotherapy.
Inclusion Criteria:
Infusion sub-study prior therapy requirements: Same as above, except:
Exclusion Criteria:
San Francisco, California 94115, United States
Winston-Salem, North Carolina 27157, United States
Aarhus N, Region Sjælland 4700, Denmark
Helsinki, Länsi-Suomen Lääni 00029, Finland
Saint-Herblain, Loire-Atlantique 44805, France
Essen, North Rhine-Westphalia 45122, Germany
Ramat Gan, Central District 52621, Israel