NCT06561022

Precision Treatment of HR+ HER2- Advanced Breast Cancer Based on SNF Molecular Subtyping

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To explore the efficacy and safety of Everolimus (SNF1 subtype) or Fluzoparib (SNF3 subtype) combined with Fulvestrant and Abemaciclib vs. Fulvestrant combined with Abemaciclib in patients with HR+/HER2- breast cancer of SNF1/SNF3 subtype who have progressed after CDK 4/6 inhibitor treatment.

Detailed description

This is a randomized, controlled, open-label, phase II study to explore the efficacy and safety of a three-drug combination of Everolimus or Fluzoparib plus Fulvestrant and Abemaciclib compared to a two-drug combination of Fulvestrant plus Abemaciclib in patients with HR+ HER2-advanced breast cancer of SNF1/SNF3 subtype who have progressed after CDK 4/6 inhibitor treatment. The study consists of Safety Lead-in phase, which aims to explore the safety and preliminary efficacy of the three-drug combination, and phase II, which aims to explore the efficacy of the three-drug combination.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Fluzoparib	Fluzoparib
DRUG	Everolimus	Everolimus
DRUG	Fulvestrant	Fulvestrant
DRUG	Abemaciclib	Abemaciclib

Timeline

• Start date: 2024-08-21
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2024-08-19
• Last updated: 2024-08-19

Locations

1 site across 1 country: China