At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed stage II or IIIA breast cancer
- ✓Age 18–70 years
- ✓Karnofsky performance status ≥80
- ✓No evidence of metastatic disease (negative staging studies)
- ✕Prior systemic therapy for breast cancer
- ✕Prior anthracyclines or taxanes for any malignancy
- ✕Prior radiotherapy for breast cancer
- ✕Bilateral invasive breast cancer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicenter Phase II Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Docetaxel (T) as Neoadjuvant Treatment for Operable Stage II and IIIA Breast Cancer Patients
In Brief
A Phase 2 clinical trial evaluating Doxorubicin, Cyclophosphamide, and 1 other intervention for Breast Cancer. Completed, enrolled 63 participants across 6 sites.
Detailed 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.