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NOT YET RECRUITING
NCT07353437
PHASE2

Fluzoparib as Adjuvant Treatment in Patients With Germline Homologous Recombination Repair (HRR) Mutated Primary Breast Cancer (Flamenco)

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

The study is a randomized, open-label, multicenter phase II clinical trial of the efficacy and safety of fluzopanib in the adjuvant treatment of early breast cancer using germline mutations in homologous recombination repair pathway genes. Study design Patients will be randomized into 2 groups in a 1:1 ratio after enrollment: Experimental group: fluzoparib, specific: fluzoparib 100 mg bid for 1 year. As well as the standard of care selected by the physician (in case of TNBC, combination therapy includes but is not limited to immunotherapy or capecitabine; in case of HR +, combination therapy includes but is not limited to endocrine therapy or CDK4/6 inhibitors). Control group: Doctors' choice of standard treatment (in case of TNBC, combination therapy includes but is not limited to immunotherapy or capecitabine; in case of HR +, combination therapy includes but is not limited to endocrine therapy or CDK4/6 inhibitors)

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

334

Start Date

2026-03-31

Completion Date

2032-12-31

Last Updated

2026-01-20

Healthy Volunteers

No

Conditions

Interventions

DRUG

Fluzoparib

Fluzoparib 100 mg bid for 1 year

DRUG

Physician choice

Standard treatment chosen by physician (in case of TNBC, combination therapy includes but is not limited to immunotherapy or capecitabine; in case of HR +, combination therapy includes but is not limited to endocrine therapy or CDK4/6 inhibitors)