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Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01)
Sponsor: Fudan University
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.
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)
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
766
Start Date
2023-06-01
Completion Date
2031-05-31
Last Updated
2024-02-08
Healthy Volunteers
No
Conditions
Interventions
Fluzoparib
Fluzoparib 50mg bid orally for 1 year.
Anastrozole
1mg, qd orally
Letrozole
2.5mg, qd orally
Exemestane
25mg, qd orally
Tamoxifen
10mg, bid orally
Toremifene
60mg, qd orally
Abemaciclib
150mg/100mg/50mg, bid orally for 2 years
LHRH agonist
Leuprorelin acetate, goserelin acetate
Locations (15)
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 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 Municipality, China
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, 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