NCT06547476

Chidamide and PD-1 Inhibitor Plus Anlotinib for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed

A Phase 2, Single Arm Study Investigating the Use of Chidamide and PD-1 Antibody Combination With Anlotinib in HER2-low, Unresectable and/or Metastatic Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This Phase II study was designed to assess the efficacy and safety of the combination of PD-1 inhibitor, Tucidinostat (chidamide), a histone deacetylase inhibitor, and anlotinib in advanced breast cancer. Participants must have HER2-low and PD-L1 positive （CPS≥1）breast cancer that has been treated before. Participants' cancer: Cannot be removed by an operation Has spread to other parts of the body

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Tucidinostat (chidamide), PD-1 inhibitor (tislelizumab), anlotinib	Tucidinostat (chidamide)，30mg, po., biw PD-1 inhibitor (tislelizumab), 200mg, ivgtt. d1, q3w anlotinib, 12mg, po., d1-14, q3w

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-06-01
• Completion: 2026-12-31
• First posted: 2024-08-09
• Last updated: 2024-08-09