CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 22 enrolled
Drug / intervention
Dalpiciclib +1 moredrug
Likely dose
Dalpiciclib 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05586841
NCT05586841Phase 1Completed
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Exploration of Dalpiciclib + Chidamide in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor: a Phase Ⅰb Study

Beijing 302 Hospital·interventional·Posted Oct 19, 2022·Updated May 29, 2026

In Brief

A Phase 1 clinical trial evaluating Dalpiciclib and Chidamide for HR+/HER2- Advanced Breast Cancer. Completed, enrolled 22 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHR+/HER2- Advanced Breast Cancer
CountriesChina
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedOct 19, 2022
Enrollment StartOct 1, 2022
Primary CompletionDec 30, 2025
Study CompletionMar 30, 2026
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 3.7 years ago

Interventions

Dalpiciclibdrug

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).

Chidamidedrug

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