A Randomized Multicenter, Open-Label, Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine versus Trastuzumab as Adjuvant Therapy for Patients with HER2-Positive Primary Breast Cancer who have Residual Tumor Present Pathologically

Service: Trial Number:
199-13
Principal Investigator: Conducted at:
Long Beach Medical Center
Currently enrolling additional patients:
Yes
Age Range:
18 & older
Gender:
Male & Female

The purpose of this study is to compare the effects, good or bad, of trastuzumab emtansine versus trastuzumab (Herceptin®) on you and your breast cancer to find out which is better. In this study, you will get either trastuzumab emtansine or trastuzumab alone. Trastuzumab emtansine is an experimental drug, which means that health authorities, such as the United States Food and Drug Administration (FDA) have not approved trastuzumab emtansine for the treatment of HER2-positive primary nonmetastatic breast cancer, except in research studies such as this one. You were selected as a possible participant in this study because you have HER2-positive primary nonmetastatic breast cancer and had evidence of cancer in your breast and lymph nodes after chemotherapy and trastuzumab