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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
155
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).
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
5mg/QW,po.
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
PFS
Progression-free survival: The time to the date of first documented progression or date of death from any cause, whichever came first
Time frame: 1 Year
ORR
Objective response rate
Time frame: 2 months
CBR
Clinical benefit rate: CR+PR+SD≥6 months
Time frame: 2 Years
DCR
Disease Control Rate: CR+PR+SD
Time frame: 2 Years
DoR
The time from the beginning of CR or PR to the time when the tumor was first evaluated as PD or any cause of death.
Time frame: 2 Years
OS
The time from the beginning of treatment to the time of death caused by any cause
Time frame: 2 Years
Safety
Adverse events (AE), serious adverse events (SAE), and immune-related adverse events (irAE), in accordance with the NCI-CTC AE version 5.0 criteria. AE recorded from infromed consent to 28 days after treatment completion.
Time frame: AE recorded from infromed consent to 28 days after treatment completion
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