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

NCT07353437 PHASE2 NOT_YET_RECRUITING

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)

Details

Lead sponsor	Fudan University
Phase	PHASE2
Status	NOT_YET_RECRUITING
Enrolment	334
Start date	Tue Mar 31 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Dec 31 2032 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Breast Cancer

Interventions

• Fluzoparib
• Physician choice