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.
Subjects voluntarily participate in this study and sign the informed consent form
aged ≥ 18 years.
ECOG PS score: 0-2 points.
Expected survival ≥ 6 months.
Previously received treatment with histone deacetylase inhibitor (HDACi);
Previously received Dalpiciclib;
MRI or lumbar puncture confirmed leptomeningeal metastasis;
Central nervous system metastasis is confirmed by imaging; The following conditions will be excluded: 1) asymptomatic brain metastases without immediate radiotherapy or surgery; 2) Previously received local treatment (radiotherapy or surgery) for brain metastases, stable for at least 4 weeks, and no symptomatic treatment (including glucocorticoids, mannitol, bevacizumab, etc.) for more than 2 weeks with clinical symptoms;
Single group
Dalpiciclib
Drug100 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
Drug25 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
Enitinostat
Drug5mg/QW，po.
PFS
Progression-free survival: The time to the date of first documented progression or date of death from any cause, whichever came first
ORR
Objective response rate
CBR
Clinical benefit rate: CR+PR+SD≥6 months
DCR
Disease Control Rate: CR+PR+SD
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.
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