NCT05464173

Chidamide in Combination With Abemaciclib and Endocrinotherapy（Doctor's Choice） in Breast Cancer Patients Previously Treated With Palbociclib

Phase Ib/II Study of Chidamide in Combination With Abemaciclib and Endocrinotherapy（Doctor's Choice） in Patients Previously Treated With Palbociclib in HR+/HER2-Relapsed/Metastatic Breast Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Biyun Wang, MD · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of chidamide in combination with abemaciclib and endocrinotherapy（doctor's choice） in locally advanced/metastatic HR+/HER2- breast cancer who had failed prior palbociclib therapy

Detailed description

Phase I (Stage Ib). To evaluate the safety and tolerability of chidamide in combination with abemaciclib and endocrinotherapy（doctor's choice） in locally advanced/metastatic HR+/HER2- breast cancer and to determine the recommended phase II dose of this combination regimen. Stage 2 (Phase II). To determine the efficacy and safety of chidamide in combination with abemaciclib and endocrinotherapy（doctor's choice） in locally advanced/metastatic HR+/HER2- breast cancer with the recommended phase II dose.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Chidamide	10-30mg biw
DRUG	Abemaciclib	150mg or 100mg bid
DRUG	endocrinotherapy（doctor's choice）	According to the drug insert

Timeline

• Start date: 2022-07-01
• Primary completion: 2025-02-01
• Completion: 2025-05-01
• First posted: 2022-07-19
• Last updated: 2024-01-22

Locations

1 site across 1 country: China