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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing 302 Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Dalpiciclib
  • Chidamide
  • Enitinostat

Treatment groups

155 Participants
are divided into 1 treatment group

Sponsors and collaborators