NCT07382687

Famitinib Combined With SHR-A1811, Versus SHR-A1811 for CDK4/6 Inhibitors-resistent Advanced HR+/HER2- Breast Cancer With SNF4 Subtype

A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Trial of Famitinib Combined With SHR-A1811, Versus SHR-A1811 for CDK4/6 Inhibitors-resistent Advanced HR+/HER2- Breast Cancer With SNF4 Subtype

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 248 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. This study aims to investigate the efficacy and safety of Famitinib combination with SHR-A1811 in CDK4/6 inhibitors-resistent advanced HR+/HER2- breast cancer with SNF4 subtype.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	SHR-A1811	SHR-A1811 4.8mg/kg iv q3w
DRUG	Famitinib+SHR-A1811	Famitinib 10mg po qd SHR-A1811 4.8mg/kg iv q3w

Timeline

• Start date: 2026-02-26
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2026-02-03
• Last updated: 2026-02-03

Locations

1 site across 1 country: China