Results from two large randomized clinical trials for patients with HER-2 positive invasive breast cancer show that those patients with early-stage breast cancer who received Herceptin® (trastuzumab) in combination with chemotherapy had a significant decrease in risk for breast cancer recurrence compared with patients who received the same chemotherapy without trastuzumab. Patients are considered HER-2 positive if their cancer cells "overexpress," or make too much of, a protein called HER2, which is found on the surface of cancer cells. Trastuzumab slows or stops the growth of these cells, and it is only used to treat cancers that overexpress the HER2 protein. Approximately 20 percent to 30 percent of breast cancers overexpress HER-2. These tumors tend to grow faster and are generally more likely to recur than tumors that do not overproduce HER-2.
The clinical trials were sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, and conducted by a network of researchers led by the National Surgical Adjuvant Breast and Bowel Project (NSABP) and the North Central Cancer Treatment Group (NCCTG), in collaboration with the Cancer and Leukemia Group B, the Eastern Cooperative Oncology Group B, and the Southwest Oncology Group. Genentech, Inc., South San Francisco, Calif., which manufactures trastuzumab, provided the drug for the trials under the Cooperative Research and Development Agreement (CRADA) with NCI for the clinical development of trastuzumab.
The Data Monitoring Committees overseeing the combined analysis of these trials (known as NSABP-B-31 and NCCTG-N9831) recommended that the results of a recent combined interim analysis be made public because the studies had met their primary endpoints of increasing disease-free survival (the amount of time patients live without return of the cancer) in patients receiving trastuzumab in combination with chemotherapy. The improvement in overall survival also was statistically significant for women receiving a combination of chemotherapy and trastuzumab.
Message posted by: Rashmi Nemade
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