A randomized Phase III trial of neoadjuvant recombinant human endostatin,docetaxel and epirubicin as first‐line therapy for patients with breast cancer (CBCRT01) |
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Authors: | Jianghao Chen Bo Wang Juliang Zhang Ting Wang Yu Ming Xiaodong Zhou Qianxin Jia Yi Huan Jing Wang Ling Wang |
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Institution: | 1. Department of Thyroid, Breast and Vascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China*J.C., Q.Y., and M.H. contributed equally to this work;2. Department of Epidemiology, Fourth Military Medical University, Xi'an, China;3. Department of Thyroid, Breast and Vascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China;4. Department of Ultrasound, Xijing Hospital, Fourth Military Medical University, Xi'an, China;5. Department of Radiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China;6. Department of Nuclear Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China |
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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 three cycles of neoadjuvant therapy, “complete response” achieved in 14.2% of patients in DEE group versus 6.7% in DE group, “partial response” achieved in 76.8% versus 71.1%, while “stable disease” in 6.0% versus 18.9%, “progressive disease” in 3.0% versus 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 pathological complete response achieved following the combination therapy, no significant difference was found between two arms. Adverse events were mostly of Grades 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. |
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Keywords: | breast cancer neoadjuvant chemotherapy recombinant human endostatin (endostar) docetaxel epirubicin |
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