Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Docetaxel as Neoadjuvant Treatment of Breast Cancer Patients
Status:
Completed
Trial end date:
2010-02-01
Target enrollment:
Participant gender:
Summary
Treatment consists of 4 AC cycles followed by 2 weekly docetaxel cycles (12 infusions).
The pathological complete response rate obtained in previous studies is around 12%. The
expected pathological complete response rate in this study is 25%. With an alpha error of
0.05 and a beta error of 0.2, and following Simon´s 2 phase test, 19 patients are needed
initially. With 2 pathological complete responses, patient recruitment will continue until
approximately 61 patients are recruited. Twelve pathological complete responses are needed to
confirm the study hypothesis.