NSABP Protocol B-47: A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Traztuzumab in Women with Node-Positive or High Risk Node Negative HER2-Low Invasive Breast Cancer
ID Number 58-0056-02047Principal Investigator(s)
Department(s) or Division(s)
Hematology and Medical Oncology
The main purpose of this study is to learn if adding a targeted therapy, trastuzumab (Herceptin®), to standard treatment with chemotherapy for early stage, HER2-low breast cancer, will prevent breast cancer from returning.
Trastuzumab is called a targeted therapy because it targets the tumor cells by blocking the HER2 protein on the surface of the cancer cell to slow down or stop cancer growth. Trastuzumab is a standard treatment for HER2-positive breast cancer. In this study, trastuzumab is considered to be investigational because it has not been studied for use in treating HER2-low breast cancer. Studies that already have been done with trastuzumab focused on breast cancers that were strongly HER2-positive. However, in some of these studies, tumor samples were checked in a central laboratory to confirm the HER2 testing results. Some breast cancers that were thought to be HER2-positive were actually HER2-low. The researchers then looked at the results of treatment in patients with HER2-low tumors. They found that trastuzumab seemed to have benefit in keeping the cancer from returning even when the HER2 levels were in the normal range. The B-47 study is being done to learn more about using trastuzumab to treat HER2-low breast cancer.
Emilie Kane (212) 824-7320
Recruiting Patients: Yes