Phase II Study of Entinostat With or Without Anlotinib Plus Fulvestrant for Treating Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer After Endocrine Therapy

What this Trial Is About

Researchers are evaluating treatments for women with hormone receptor-positive, HER2-negative advanced breast cancer that has returned or progressed after endocrine therapy. This phase II clinical trial studies the effects of entinostat combined with fulvestrant, with or without the addition of anlotinib, in patients who have previously been treated with CDK46 inhibitors. The study aims to understand how these treatments affect tumor response and disease progression. Participants receive entinostat tablets once a week and fulvestrant injections on specific days within a 28-day cycle. One group receives just entinostat and fulvestrant, while another group receives those plus anlotinib capsules taken daily for two weeks followed by a one-week break, forming a 3-week treatment cycle. Treatment continues until disease progression, intolerable side effects, withdrawal, or other protocol-defined conditions occur. Throughout the study, tumor response is evaluated every 8 weeks using RECIST criteria. Safety is continuously monitored during treatment, with follow-up visits shortly after treatment ends. The study concludes when disease progression occurs or when treatment stops for any reason. Participants are assessed up to two years for response rate, progression-free survival, clinical benefit, and duration of response.

A Phase II Clinical Study Evaluating Entinostat With or Without Anlotinib + Fulvestrant for the Treatment of Hormone Receptor (HR) -Positive, Human Epidermal Growth Factor Receptor-2 (HER-2) -Negative Advanced Breast Cancer That Relapsed or Progressed After Endocrine Therapy