Chemotherapy With or Without Trastuzumab after Surgery as Treatment for Breast Cancer
The purpose of this study is to determine if chemotherapy after surgery works better with or without trastuzumab as treatment for women with invasive breast cancer. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving chemotherapy after surgery may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. The primary objective is to determine which treatment works better based on how long it takes for breast cancer to come back, if ever. The study will enroll 3,260 participants from many cancer centers in the US. After completing study treatment, patients are followed up every 6 months for 5 years and then every 12 months for 5 years. In addition to other conditions for enrollment, a woman with no evidence of cancer after surgery to remove the breast cancer, and the surgery was within the past 84 days. Radiation therapy must be completed at the time of study enrollment. Eligible patients have at least 1 positive lymph node but no evidence of cancer that has spread beyond the breast or lymph nodes. Eligible patients cannot have a history of heart disease, uncontrolled diabetes, active hepatitis B or C, or shortness of breath due to an existing lung problem. Patients with inflammatory breast cancer are not eligible.