NCT05759546

PARP Inhibitor With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2-Advanced Breast Cancer

PARP Inhibitor in Combination With CDK4/6 Inhibitor and Endocrine Therapy as the First-line Therapy for HR+/ HER2-Advanced Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.

Detailed description

Patients with SNF3 subtype of HR+/HER2- advanced breast cancer confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital are planned to be enrolled. The main purpose is to evaluate efficacy of PARP inhibitor in SNF3 subtype of HR+/HER2- advanced breast cancer and prepare for subsequent randomized controlled phase III clinical studies with larger sample size.

Conditions

• Breast Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Fluzoparib	Parp inhibitor
DRUG	Dalpiciclib	CDK4/6 inhibitor
DRUG	Fulvestrant/AI	Endocrine therapy

Timeline

• Start date: 2023-02-01
• Primary completion: 2025-11-01
• Completion: 2027-06-01
• First posted: 2023-03-08
• Last updated: 2024-02-06

Locations

1 site across 1 country: China