Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: A randomized, controlled, open phase IIb study

Purpose: To investigate the effect of adding tamoxifen to a preoperative do se-dense doxorubicin and docetaxel regimen on the pathologic response of pr imary operable breast cancer. Patients and Methods: Patients (tumor size greater than or equal to 3 cm, N O to 2, MO) were prospectively randomized to receive every 14 days a total of four cycles of doxorubicin 50 mg/m(2) and docetaxel 75 mg/m(2), either w ith (ADocT) or without (ADoc) simultaneous tamoxifen. Granulocyte colony-st imulating factor (G-CSF) was routinely given on days 5 to 10. Surgery follo wed 8 to 10 weeks after the start of treatment. Results: Within 14 months, 250 patients were included in the study at 56 ce nters. Of 992 planned cycles, 97.9% were administered. Pathologically compl ete remission (pCR) with no detectable viable tumor cells was achieved in 9 .7%. There was a nonsignificant difference of -1.2% in favor of ADoc, with a 95% confidence interval of -8.6% to 6.2%. A further 2.4% had only noninva sive tumor residues, and 13.8% had focal invasive residues. Complete and pa rtial responses detected by palpation were observed in 28.9% and 52.4%, res pectively. The response rates (complete and partial) by best appropriate im aging methods were 77.5% and 67.5% for ADocT and ADoc, respectively. Breast conservation was possible in 68.8% of the patients. A tendency toward more frequent toxic events was observed with ADocT treatment. Significant predi ctors of pCR to chemotherapy were negative lymph node and negative estrogen receptor status. Conclusion: A dose-dense regimen of ADoc with G-CSF offers high compliance, moderate toxicity, and rapid efficacy as a form of preoperative chemothera py in operable breast cancer. Concurrent treatment with tamoxifen for 8 wee ks could not improve the pathologic response rate.