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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
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).
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
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
Maximum Tolerated Dose (MTD) of Dalpiciclib + Chidamide
Bayesian optimal interval (BOIN) design method will be used in this clinical trial to determine the maximum tolerated dose (MTD).
Time frame: 2 Years
Objective response rate (ORR) of different dose groups
According to recist1.1 standard, the proportion of patients whose best remission was CR or PR accounted for the total number of evaluable patients.
Time frame: 2 Years
Safety of different dose groups (incidence of treatment-related adverse events)
The severity of adverse events shall be determined according to CTCAE v5.0. During the trial, the adverse event record form should be truthfully filled in, including the occurrence time, severity, duration, measures taken and outcome of adverse events.
Time frame: AE recorded from infromed consent to 28 days after treatment completion
PFS
The time from the date of randomization to the date of first documented progression or date of death from any cause, whichever came first.
Time frame: 2 Years
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