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

* This study was an open, multicenter phase II clinical trial that enrolled 118 patients with HR+/HER2- with recurrent or progressive advanced breast cancer treated with CDK4/6 inhibitors; * The study adopted the Simon phase 2 design, and all 20 eligible patients were treated with entinostat + fulvestrant; The study was terminated if no more than 2 patients achieved objective response and continued to enter Phase 2 if no more than 3 patients achieved objective response. In Phase 2, qualified patients were randomly assigned at a ratio of 1:1.5 to either the entestasta + fluvestrus group (Group

Trial Details

NCT ID

NCT07330544

Phase

PHASE2

Sponsor

Zhejiang Cancer Hospital

Status

RECRUITING

Cancer Type

HER2 Negative Breast Cancer

Interventions

• entinostat
• Fulvestrant
• Anlotinib

Locations (sample)

• Zhejiang, Hangzhou, China|25.3238,105.583

Key Eligibility Criteria

• Sign an informed consent form;
• Female, aged 18 or above;
• The patient's Eastern Tumor Collaboration Group (ECOG) physical status is 0-1;
• The patient's expected survival time is ≥3 months;

For full eligibility, visit ClinicalTrials.gov.

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