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Breast Cancer Internl. Res. Group
BCIRG 001 study is the basis for U.S. FDA approval of docetaxel
September 24th, 2004
The U.S. Food and Drug Administration (FDA) recently approved the use of the docetaxel-based regimen (TAC) for the treatment of patients with operable, node-positive, early stage breast cancer. The FDA based its decision on data from a pivotal study conducted by the Breast Cancer International Research Group (BCIRG). The study, known as BCIRG 001, demonstrates that women with node-positive, early-stage breast cancer who received TAC (docetaxel with doxorubicin and cyclophosphamide) after surgery experienced a 25.7% reduction in their risk of relapse (the chance of their cancer returning) as compared to women treated with a standard adjuvant regimen...
Source: Food & Drug Law Weekly (2004-09-24)
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