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COMPLETED
NCT05586841
PHASE1

Exploration of Dalpiciclib + Chidamide in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor: a Phase Ⅰb Study

Sponsor: Beijing 302 Hospital

View on ClinicalTrials.gov

Summary

A phase 1B study to explore the maximum tolerated dose (MTD) of dalpiciclib + chidamide in HR+/HER2- advanced breast cancer after the failure of CDK4/6 inhibitor therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2022-10-01

Completion Date

2026-03-30

Last Updated

2026-05-29

Healthy Volunteers

No

Interventions

DRUG

Dalpiciclib

Dalpiciclib: 100 mg/d or 125 mg/d, po., qd, administered on an empty stomach (fasting should be ensured at least 1 hour before and 1 hour after administration). The drug will be administered in a 28-day cycle, with continuously administration in the first 3 weeks (D1-21), and discontinuation in the fourth week (D22-28).

DRUG

Chidamide

Chidamide: 25 mg/BIW or 20 mg/BIW, po., q2w. The interval between doses should not be less than 3 days (e.g. Monday and Thursday, Tuesday and Friday, Wednesday and Saturday, etc.), administered 30 minutes after meals

Locations (1)

The Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, China