drugset / Trial / NCT07235618

A Study of Entinostat in Combination With Fulvestrant for the Treatment of Locally Advanced or Metastatic Breast Cancer

NCT07235618

Phase 2 Not yet recruiting 50 enrolled Sun Yat-sen University
NaSingle-groupOpen-labelTreatment

Summary

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 .

Timeline

Start
2026-01-05
Primary completion
2028-01
Completion
2028-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Entinostat Small molecule 5 mg Oral
Subject Fulvestrant Small molecule 500 mg Intramuscular

Indications