TRIAL COMPARING SAFETY AND EFFICACY OF AC-T TO AC-T+H IN NODE-POSITIVE BREAST CA

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study will evaluate the worth of Herceptin in patients with node-positive breast tumors that overexpress the HER2 protein. This phase III, randomized trial will be conducted in two stages. The first stage will evaluate cardiac safety and determine the toxicities of adding weekly Herceptin (H) to adjuvant Taxol following Adriamycin and cyclophosphamide (AC). Provided that the incidence of cardiac toxicity in the study arm (AC-T+H) falls within the boundaries set by the protocol, the study will proceed to the second stage. The second stage will increase patient accrual to allow an evaluation of the efficacy of adding Herceptin to chemotherapy in prolonging survival (S) and disease-free survival (DFS).