Phase III study evaluating the role of docetaxel in the adjuvant setting of breast cancer patients with ≥ 4 involved lymph nodes: ADEBAR-Study

Abstract

908 Background: The current data of the BCIRG 001-study support the probable advantage of the taxanes in the adjuvant therapy of primary breast cancer. Nevertheless, the indication for breast cancer patients with more than 3 involved lymph nodes, as well as the optimal scheduling still remains unclear. Aim of this ongoing study is to compare toxicity and survival rates of patients with either taxane or anthracycline based therapy. Methods: Open-label, multicenter, phase III study prospectivelly randomising to adjuvant chemotherapy with 4 cycles of Epirubicin 90 mg/m2 and Cyclophosphamide 600 mg/m2 q3w followed by 4 cycles of Docetaxel 100 mg/m2 q3w (EC-Doc) or 6 cycles of Epirubicin 60 mg/m2 i.v. d 1+8, 5-Fluorouracil 500 mg/m2 i.v. d 1+8 and Cyclophosphamide 75 mg/m2 p.o. d 1–14, q4w. Patients with positive hormone receptor status will receive endocrine therapy, and all patients will be required to receive adjuvant radiotherapy. Results: On 30/09/04 1202 pts. have been randomised in 195 recruiting centers. Primary tumor characteristics like tumor size (p = .24), axillary lymph node status (p = .84) and hormone receptor status (p = .78) were well balanced between both therapy arms. The tumor size of 28% of the pts. has been under 2cm, 59% of pts. had a tumor size of 2 cm to 5 cm. 46,9% were low differentiated (G 3). 60,2% of the pts. had 4–9 lymph nodes involved, while 39,8% presented more than 10 afflicted lymph nodes. In 83,5%, radiotherapy was performed after the completion of all chemotherapy cycles, in 16,5% radiotherapy was performed after completing half of the chemotherapy cycles. Serious adverse events were associated in 4,7% of all cycles, but most of the time not in causal relation. In the adjunct scientific program, the predictive value of uPA/PAI-1 on the primary tumor and of disseminated tumor cells in the bone marrow at primary diagnosis and after completion of chemotherapy is investigated. Conclusions: The excellent recruitment and the limited amount of complications confirm the uncomplicated accomplishment and good feasibility of this trial. The ADEBAR-Study will contribute further information on the role of taxanes in the adjuvant setting of high risk breast cancer patients. No significant financial relationships to disclose.