Significantly Higher Pathologic Complete Remission Rate After Neoadjuvant Therapy With Trastuzumab, Paclitaxel, and Epirubicin Chemotherapy: Results of a Randomized Trial in Human Epidermal Growth Factor Receptor 2–Positive Operable Breast Cancer

• DOI: 10.1200/jco.2005.07.032
• Publication Date: 2005-03-01T01:25:05Z
• Authors: Aman U. Buzdar; Nuhad K. Ibrahim; Deborah Francis; Daniel J. Booser; Eva S. Thomas; Richard L. Theriault; Lajos Pusztai; Marjorie C. Green; Banu K. Arun; Sharon H. Giordano; Massimo Cristofan...; Debra K. Frye; Terry L. Smith; Kelly K. Hunt; Sonja E. Singletary; Aysegul A. Sahin; Michael S. Ewer; Thomas A. Buchholz; Donald Berry; Gabriel N. Hortob...
• Keywords: Epirubicin

Purpose The objective of this study was to determine whether the addition trastuzumab chemotherapy in neoadjuvant setting could increase pathologic complete response (pCR) rate patients with human epidermal growth factor receptor 2 (HER2) –positive disease. Patients and Methods Forty-two HER2-positive disease operable breast cancer were randomly assigned either four cycles paclitaxel followed by fluorouracil, epirubicin, cyclophosphamide or same simultaneous weekly for 24 weeks. primary demonstrate a 20% improvement pCR (assumed 21% 41%) chemotherapy. planned sample size 164 patients. Results Prognostic factors similar two groups. After 34 had completed therapy, trial's Data Monitoring Committee stopped trial because superiority plus rates 25% 66.7% (n = 16) 18), respectively (P .02). decision based on calculation that, if continued patients, there 95% probability that would be superior. Of 42 randomized 26% arm achieved compared 65.2% .016). safety approach is not established, although no clinical congestive heart failure observed. A more than 10% decrease cardiac ejection fraction observed five seven arms, respectively. Conclusion Despite small size, these data indicate adding chemotherapy, as used trial, significantly increased without failure.