Chidamide/Everolimus for PIK3CA Wild-type/Mutant HR+/HER2- Advanced Breast Cancer

To explore the efficacy and safety of chidamide combined with endocrine in phosphoinositide-3-kinase,catalytic,alpha gene(PI3KCA) wild type hormone receptor positive(HR+)/human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer patients and to explore the efficacy and safety of Everolimus combined with endocrine therapy in patients with PI3KCA Mutant HR+/HER2- advanced breast cancer.

Trial Details

NCT ID
NCT05983107
Phase
PHASE2
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • Everolimus
  • Chidamide
  • Endocrine therapy
  • Ovarian function suppression(OFS)
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723

Key Eligibility Criteria

  • The age at the time of signing the informed consent form is ≥ 18 years old and ≤ 75 years old, for menopausal/premenopausal women (premenopausal wo…
  • Breast cancer patients with HR positive (ER expression ≥ 10%, PR positive or negative) and HER2 negative (Immunohistochemical(IHC)0,1+; 2+, Fluores…
  • Histologically confirmed locally advanced breast cancer (no radical local treatment) or recurrent and metastatic breast cancer.
  • The patients who had previously progressed after the treatment of first-line or second-line cyclin-dependent kinases 4 and 6 inhibitors（CDK4/6 inhi…

For full eligibility, visit ClinicalTrials.gov.

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