Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05891093
PHASE3

Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01)

Sponsor: Fudan University

View on ClinicalTrials.gov

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

DRUG

Fluzoparib

Fluzoparib 50mg bid orally for 1 year.

DRUG

Anastrozole

1mg, qd orally

DRUG

Letrozole

2.5mg, qd orally

DRUG

Exemestane

25mg, qd orally

DRUG

Tamoxifen

10mg, bid orally

DRUG

Toremifene

60mg, qd orally

DRUG

Abemaciclib

150mg/100mg/50mg, bid orally for 2 years

DRUG

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