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Brief Title: Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01)
Official Title: A Prospective, Randomized, Open-label Phase III Clinical Study of the Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy Versus Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01)
Study ID: NCT05891093
Brief Summary: This is a prospective, randomized, open-label phase III clinical study on the efficacy and safety of fluzoparib combined with adjuvant endocrine therapy versus adjuvant endocrine therapy for HR+/HER2- SNF3-subtype early breast cancer.
Detailed Description: This is a prospective, randomized, open-label phase III clinical study on the efficacy and safety of fluzoparib combined with adjuvant endocrine therapy versus adjuvant endocrine therapy for HR+/HER2- SNF3-subtype early breast cancer. A total of 766 patients with luminal-type early breast cancer who received surgery at the Fudan University Shanghai Cancer Cancer and were classified as SNF3 (proliferative) by SNF algorithm fusion clustering will be collected for this study. Before enrollment, the primary tumors of the patients were subjected to molecular typing based on H\&E slices combined with digital pathology, and subsequent enrollment could be considered if patient pathology was confirmed as SNF3 subtype.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Beijing Cancer Hospital, Beijing, Beijing, China
Chongqing Cancer Hospital, Chongqing, Chongqing, China
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Guangdong Academy of Medical Sciences Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center, Guangdong, Guangzhou, China
Affiliated Hospital of Nantong University, Nantong, Jiangsu, China
Northern Jiangsu People's Hospital, Yangzhou, Jiangsu, China
The First Hospital of China Medical University, Shenyang, Liaoning, China
Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University, Shanghai, Shanghai, China
Shanghai First Maternity and Infant Hospital, Shanghai, Shanghai, China
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi, China
West China Hospital of Sichuan University, Chengdu, Sichuan, China
Ningbo Medical Center Lihuili Hospital, Ningbo, Zhejiang, China