RecruitingPhase 2NCT07330544

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

A Phase II Clinical Study Evaluating Entinostatwit h 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


Sponsor

Zhejiang Cancer Hospital

Enrollment

118 participants

Start Date

Nov 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

* 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 1) or the anlotinib + entestasta + fluvestrus group (Group 2), with 39 patients enrolled in group 1 and 59 patients enrolled in group 2; All patients were treated until the subjects' treatment would continue until the subjects experienced disease progression, intolerable toxicity, active withdrawal from treatment, or other conditions specified in the protocol, whichever occurred first. * During the study period, efficacy evaluations will be conducted every 8 weeks in accordance with the Solid Tumor Efficacy Evaluation Criteria (RECIST) v1.1 until disease progression, the initiation of a new anti-tumor treatment by the subject, or the withdrawal of informed consent, whichever occurs first. * Continuous safety evaluations will be conducted during the study treatment period. All subjects who have received at least one study treatment will be required to undergo end-of-treatment visits and safety follow-up visits within 7 days and 30±2 days after the last study treatment, respectively. * The end of the study was defined as the occurrence of disease progression or the end of the study treatment in all subjects, or the early termination of the study for other reasons, whichever occurred first.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an HDAC inhibitor drug (entinostat) — alone or together with a targeted anti-cancer drug (anlotinib) — to hormone therapy (fulvestrant) can help women with hormone receptor-positive, HER2-negative advanced breast cancer that has stopped responding to prior endocrine treatments. **You may be eligible if...** - You are a woman aged 18 or older - You have hormone receptor-positive (ER+), HER2-negative advanced breast cancer confirmed by biopsy - Your cancer has progressed after receiving at least one line of endocrine therapy and a CDK4/6 inhibitor - You have not yet received chemotherapy or antibody-drug conjugate (ADC) therapy for your advanced breast cancer - You are in good general health (ECOG performance status 0–1) with an expected survival of at least 3 months - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - You are HER2-positive - You have not previously received endocrine therapy or a CDK4/6 inhibitor - You have already received chemotherapy or ADC therapy for metastatic disease - You are in poor general health Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGentinostat

Entinostat tablets, orally once a week (5 mg); Each treatment cycle lasts for 28 days. Treatment will continue until the subject experiences disease progression, intolerable toxicity, voluntary withdrawal, or any other condition specified in the protocol, whichever occurs first.

DRUGFulvestrant

Fulvestrant, intramuscular injection, 500 mg each time, administered on d1 and d15 of the first cycle, and on d1 of each subsequent cycle. Each treatment cycle lasts for 28 days. Treatment will continue until the subject experiences disease progression, intolerable toxicity, voluntary withdrawal, or any other condition specified in the protocol, whichever occurs first.

DRUGAnlotinib

Anlotinib, 10mg each time, once daily, orally before breakfast. Take the drug for 2 consecutive weeks and then stop for 1 week, that is, 3 weeks (21 days) as one course of treatment.


Locations(1)

Zhejiang Cancer Hospital

Zhejiang, Hangzhou, China

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NCT07330544


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