This study aims to evaluate the efficacy of Entinostat combined with Fulvestrant in HR+/HER2- advanced breast cancer patients with recurrence/progression after endocrine therapy (primary endpoint: progression-free survival \[PFS\]), and explore the correlation between peripheral blood mononuclear cell (PBMC) acetylation levels and treatment response to determine the baseline acetylation threshold .
Signed informed consent form.
Female participants aged ≥18 and ≤75 years. 3 .Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
. Hormone receptor positivity is defined by the presence of estrogen receptors (ER), where a threshold of ≥10% positive staining cells is considered indicative of positivity. The status of progesterone receptors (PR) can be either negative or positive, with the same criterion of ≥10% positive staining cells applied to determine receptor positivity.
. HER-2 negativity indicates that the immunohistochemical assessment of the pathological specimen yields a result classified as 0 or 1+. Alternatively, a result classified as 2+ may also be deemed HER-2 negative if corroborated by negative findings from ISH or FISH testing.
Presence of current or prior Central Nervous System (CNS) metastases or leptomeningeal disease (LMD).
Prior treatment with Selective Estrogen Receptor Degraders (SERD, e.g., fulvestrant) or Histone Deacetylase (HDAC) inhibitors (e.g., entinostat, chidamide).
Known to be allergic to SERD, entinostat or other drugs with a benzamide structure (such as tyapride, remopilib, cloprapride, etc.).
Pregnant or lactating women.
Single group
Entinostat
DrugEntinostat (5mg/week, po)
Fulvestrant
DrugFulvestrant( 500 mg intramuscularly on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28-day cycle)
Progression Free Survival (PFS)
Progression-free survival(PFS) is defined as the time from treatment initiation to disease progression or death from any cause.
Overall Survival(OS)
Overall survival (OS) is defined as the time from treatment initiation to death from any cause.
Objective Response Rate(ORR)
Objective response rate (ORR) is defined as the percetage of participants achieving a complete response (CR) or partial response (PR) according to RECIST v.1.1.
Clinical Benefit Rate(CBR)
Clinical Benefit Rate(CBR) is defined as the percetage of participants achieving a complete response (CR) and partial response (PR) and stable disease （SD）≥ 24 weeks according to RECIST v.1.1.
Duration of response(DOR)
Duration of response (DOR) is defined as the duration from response initiation (when either CR or PR ) to progression or death, whichever occurs first.
Biomarker analysis(protein lysine acetylation of peripheral blood samples (PBMCs))
Protein lysine acetylation of peripheral blood samples (PBMCs) will be assessed at baseline, the first day of the first cycle,the 15th day of the first cycle, the first day of the fourth cycle, and the 15th day of fourth cycle, at the end of the treatmentthe fourth cycle, and the 15th day of fourth cycle, at the end of the treatment
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