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NOT YET RECRUITING
NCT06556862
PHASE2

Exploration of Dalpiciclib Plus HDACi in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor

Sponsor: Beijing 302 Hospital

View on ClinicalTrials.gov

Summary

A phase II study to explore the efficacy and safety of dalpiciclib plus HDACi in HR+/HER2- advanced breast cancer after the failure of CDK4/6 inhibitor therapy.

Official title: Exploration of Dalpiciclib Plus HDACi in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor: a Phase II Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

155

Start Date

2025-10-01

Completion Date

2028-12-31

Last Updated

2025-08-13

Healthy Volunteers

No

Interventions

DRUG

Dalpiciclib

100 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

25 mg/BIW, po. 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

DRUG

Enitinostat

5mg/QW,po.

Locations (1)

The Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, China