研究单位：[1]China Breast Cancer Clinical Study Group[2]Cancer Institute and Hospital, Chinese Academy of Medical Sciences,Beijing,Beijing,China,100021[3]Pekingn Union Medical College Hospital,Beijing,Beijing,China,100032[4]Beijing Friendship Hospital, Capital Medical University,Beijing,Beijing,China,100050[5]PLA 307 Hospital,Beijing,Beijing,China,100071[6]The General Hospital of the People's Liberation Army,Beijing,Beijing,China,100853[7]The First Affi liated Hospital of Chongqing Medical University,Chongqing,Chongqing,China,400016[8]South West Hospital,Chongqing,Chongqing,China,400038[9]Gansu Cancer Hospital,Lanzhou,Gansu,China,730050[10]Guangdong Provincial Hospital of Traditional Chinese Medicine,Guangzhou,Guangdong,China,510120[11]Second Affiliated Hospital of Zhongshan University,Guangzhou,Guangdong,China,510120[12]Cancer Hospital of Shantou Medical College,Shantou,Guangdong,China,515041[13]Affiliated Hospital of Guiyang Medical College,Guiyang,Guizhou,China,550002[14]The Fourth Clinical Medical College of Hebei Medical University,Shijiazhuang,Hebei,China,050011[15]The second affiliated hospital of Harbin Medical University,Harbin,Heilongjiang,China,150001[16]The third affiliated hospital of Harbin Medical University,Harbin,Heilongjiang,China,150040[17]Henan cancer hospital affiliated to Zhengzhou university,Zhengzhou,Henan,China,450008[18]Hubei General Hospital,Wuhan,Hubei,China,430070[19]Xiangya Hospital Central-south University,Changsha,Hunan,China,410008[20]Jiangsu Cancer Hospital,Suzhou,Jiangsu,China,210000[21]Jiangsu Province Hospital,Suzhou,Jiangsu,China,210029[22]The Second Affiliated Hospital of Soochow University,Suzhou,Jiangsu,China,215004[23]Third Affiliated Hospital of Nanchang University,Nanchang,Jiangxi,China,330009[24]Jinlin Cancer Hospital & Institute,Changchun,Jilin,China,130012[25]The First Hospital of Jilin University,Changchun,Jilin,China,130021[26]The First Hospital of China Medical University,Shenyang,Liaoning,China,110001[27]Fudan University Shanghai Cancer Center,Shanghai,Shanghai,China,200032[28]Zhongshan Hospital, Fudan University,Shanghai,Shanghai,China,200032[29]Huashan Hospital, Fudan University,Shanghai,Shanghai,China,200040[30]Shanghai 6th People''s Hospital,Shanghai,Shanghai,China,200233[31]Changhai Hospital of Shanghai,Shanghai,Shanghai,China,200433[32]Shanxi Cancer Hospital,Taiyuan,Shanxi,China,030013[33]Second Affiliated Hospital of Medical College of Xi''An Jiaotong University,Xi''an,Shanxi,China,710004[34]Tianjin Medical University Cancer Institute and Hospital,Tianjin,Tianjin,China,300060[35]Xinjiang Cancer Hospital,Wulumuqi,Xinjiang,China,830000[36]Zhejiang First Hospital,Hangzhou,Zhejiang,China,310003[37]Second Affiliated Hospital Zhejiang University School of Medicine,Hangzhou,Zhejiang,China,310009[38]The First Hospital of Wenzhou Medical College,Wenzhou,Zhejiang,China,325000
Recent clinical studies showed that triple-negative breast cancer patients (ER-/PR-/HER2-) may benefit more from Capecitabine chemotherapy. However, the optimum post-operative adjuvant Capecitabine chemotherapy regimen has not been determined for Chinese population with triple-negative breast cancer. Thus it's necessary to conduct a multi-center Phase III clinical trial to verify efficacy and safety of Capecitabine in the treatment of triple-negative breast cancer. In this study, a prospective, randomized, open, multi-center Phase III clinical study was conducted to compare efficacy and safety of sequential Docetaxel followed by Fluorouracil/Epirubicin/Cyclophosphamide (FEC) and sequential Docetaxel and Capecitabine followed by Capecitabine/Epirubicin/Cyclophosphamide (XEC) as post-operative adjuvant chemotherapy in the treatment of triple-negative breast cancer in Chinese population.
