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

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 1, 2022

Primary Completion Date

November 30, 2024

Study Completion Date

November 30, 2025

Conditions
HR+/HER2- Advanced Breast Cancer
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

Trial Locations (1)

100071

The Fifth Medical Center of PLA General Hospital, Beijing

All Listed Sponsors
lead

Beijing 302 Hospital

OTHER

NCT05586841 - Exploration of Dalpiciclib + Chidamide in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor: a Phase Ⅰb Study | Biotech Hunter | Biotech Hunter