Trial of adjuvant therapy for early stage, HER2-low invasive cancer
The purpose of this study is to learn if adding a targeted therapy, trastuzumab (Herceptin¨), to a standard chemotherapy treatment for early stage, HER2-low invasive breast cancer, will prevent the 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 investigational because it has not been studied for use in treating HER2-low breast cancer.
Your doctor will decide with you what type of chemotherapy is appropriate for your breast cancer. Some patients will receive chemotherapy alone, while other will receive trastuzumab in addition to chemotherapy. This will be determined by the study in a process called randomization, a process much like the tossing of a coin. Chemotherapy will take about 4_ to 6 months to complete, depending on the chemotherapy you are receiving and your treatment schedule After patients have completed the study therapy, the patient will be asked to visit the office for follow-up exams for 10 years.
Patients must have primary invasive adenocarcinoma of one breast with a specific staging. To be eligible, the date you had surgery and the date you would start your medication can not be more than 84 days.
Nina D'Abreo, MD
Patricia Ly, RN MSN ANP