NCT07353437

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 334 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2026-03-31
• Primary completion: 2031-12-31
• Completion: 2032-12-31
• First posted: 2026-01-20
• Last updated: 2026-01-20