Participation in a randomized phase III study (evaluating the role of adjuvant docetaxel in high-risk breast cancer patients) improves treatment strategies and individual patient care in recruiting centers: The ADEBAR-Trial

Abstract

789 Background: Substantial improvements in the treatment of breast cancer were made possible by a large number of clinical trials. While the scientific impact of clinical trials is undisputable, the individual patient’s benefit of participating in a clinical trial remains controversial. On the basis of a phase III trial, we evaluated its impact on current treatment practice. Methods: ADEBAR is a multicenter phase III trial to evaluate whether breast cancer patients with > 3 axillary lymph node metastases benefit from a sequential anthracycline-docetaxel regimen (E90C-D: 4 cycles epirubicin [E] 90 mg/m2 plus cyclophosphamide [C] 600 mg/m2 q21d, followed by 4 cycles docetaxel [D] 100mg/m2 q21d) compared to dose-intensive anthracycline-containing polychemotherapy (FE120C: 6 cycles E 60 mg/m2 d 1+8, 5-FU 500mg/m2 d 1+8 and C 75 mg/m2 d 1–14, q4w). A questionnaire was sent to all participating centers (comprising large hospital departments and community oncology practices) in order to evaluate, in which exten...