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

Abstract

587 Background: ADEBAR is a multicenter phase III trial to evaluate whether breast cancer (BC) pts with > 3 axillary lymph metastases benefit from a sequential anthracycline-docetaxel regimen (E90C–D: 4 cycles epirubicin [E] 90 mg/m2 plus cyclophosphamide [C] 600 mg/m2 q21 days followed by 4 cycles docetaxel [D] 100mg/m2 q21 days) 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, q4 weeks). ADEBAR is currently the best recruiting adjuvant chemotherapy trial in this specific risk group in Germany. Patients and Methods: As of 1.12.2003, 149 actively participating centers recruited 675 patients (25.0 patients/month, median) in the ADEBAR-study. A questionnaire was sent to all participating centers (comprising large hospital departments and community oncology practices) in order to evaluate, in which extend their participation in the ADEBAR-study had changed their treatment strategies and patient care. Results: 67.4% (n=93) of the questionnaires were returned. In the year preceding ADEBAR, 54.8% of study centers had not entered high-risk breast cancer patients into a clinical trial. Outside of the ADEBAR protocol, 51.7% of high-risk patients would have routinely received less effective chemotherapy, such as CMF or EC/CMF. 43% of centers reported that participating in the trial had increased their intensitiy of patient care and 53.7 % noted an improvement in their professional knowledge by being part of an investigators' network. More than one third of the centers (35.5%) reported substantial improvements in the overall quality of their patient care. Conclusion: Our results demonstrate that, by participation in clinical trials, there is an improvement of treatment strategies and individual patient care in recruiting centers. Moreover, our excellent recruitment rate demonstrates that modern trials, which are easy to carry out under routine care conditions, have the potential of acquiring additional centers to conduct clinical trials. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis Aventis; Amgen; Pfizer; Novartis; AstraZeneca