BIG 4-11 / BO25126 / TOC4939G - A randomized multicenter, double-blind, placebo-controlled comparison of chemotherapy plus trastuzumab plus placebo versus chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in patients with operable HER2-positive primary breast cancer
Participants in this study have been diagnosed with a certain type of breast cancer called HER2-positive breast cancer. They have completed surgery to remove the cancer but require further treatment. The purpose of this study is to investigate a new drug called pertuzumab.
This research is being conducted by the Breast International Group (BIG), a non-profit organization for breast cancer research, as well as other research institutions like the University of Iowa Hospitals and Clinics.
Approximately 3800 subjects altogether will take part in the study. The duration of this study will be approximately 13 years, including follow-up. Participants seen or contacted at regular intervals for this period of time.