NSABP Protocol B-27. Preoperative doxorubicin plus cyclophosphamide followed by preoperative or postoperative...

Protocol B-27, conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP), is a phase III, randomized trial designed to evaluate whether sequencing docetaxel (Taxotere) to neoadjuvant doxorubicin/cyclophosphamide (Cytoxan, Neosar) prolongs disease-free and overall survival in patients with operable breast cancer. Patients are being randomized into three groups. The control group receives four 21-day courses of doxorubicin/cyclophosphamide chemotherapy with tamoxifen (Nolvadex), followed by breast surgery (and postoperative radiation for patients receiving breast-conserving surgery). Two experimental groups receive the same doxorubicin/cyclophosphamide chemotherapy and tamoxifen, followed by docetaxel--either before (preoperative group) or after (postoperative group) surgery. In the first 11 months of the study, 283 patients--of a projected 1,606 patients over a 5-year period--have been entered. Slightly more than half of the patients are younger than 50 years of age. Nearly half of the patients presented with tumors that were more than 4.0 cm in greatest diameter. Biopsy was performed by fine-needle aspiration slightly more than half of the time. Slightly more than two-thirds of the patients had clinically negative nodes. Lumpectomy was the proposed surgery at entry in 40% to 43% of the patients. As of November 1996, toxicity information is available on 29 patients in the preoperative docetaxel group and 23 patients in the postoperative docetaxel group. So far, there have been no unexpected toxicities, but the data are too preliminary to report in detail.