A Randomized Phase III Trial of Neoadjuvant Recombinant Human Endostatin, Docetaxel and Epirubicin as First-Line Therapy for Patients with Breast Cancer (CBCRT01)

Abstract

To further assess the efficacy and safety of recombinant human endostatin (rh-endostatin), a phase III, multicenter, prospective, randomized, controlled clinical trial was conducted. Patients to be treated with neoadjuvant docetaxel and epirubicin (DE) or DE plus rh-endostatin (DEE) were eligible for this trial. The primary endpoint was clinical/pathological response. Secondary endpoints included adverse events and quality of life (QOL). Finally, 803 patients were enrolled and randomly assigned to receive DE (n = 402) or DEE (n = 401) regimen. After 3 cycles of neoadjuvant therapy, CR achieved in 14.2% of patients in DEE group vs 6.7% in DE group, PR achieved in 76.8% vs 71.1%, while SD in 6.0% vs 18.9%, PD in 3.0% vs 3.2% of patients. The rate of objective response in DEE and DE group was 91.0% and 77.9%, respectively (P < 0.001). In spite of a relatively higher pCR achieved following the combination therapy, no significant difference was found between two arms. Adverse events were mostly of grade 1-2. No significant difference in adverse event and QOL was found between the two arms. In conclusion, the combination of chemotherapy and rh-endostatin achieved better outcomes than chemotherapy alone, and thus can be considered as a promising therapeutic strategy for breast cancer. This article is protected by copyright. All rights reserved.

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