Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT07330544

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

Led by Zhejiang Cancer Hospital · Updated on 2026-01-09

118

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

* 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent form
  • Female, aged 18 years or older
  • Eastern Tumor Collaboration Group (ECOG) physical status of 0-1
  • Expected survival time of at least 3 months
  • Diagnosis of hormone receptor-positive and HER2-negative breast cancer confirmed by recent tumor tests
  • Received at least one line of endocrine therapy and CDK4/6 inhibitor therapy for unresectable locally advanced recurrence or metastasis, or recurrence during or within 12 months after such therapy
  • No prior chemotherapy or antibody-drug conjugate therapy for metastatic disease
  • At least one measurable target lesion per RECIST 1.1 evaluation
  • No known active brain metastases or leptomeningeal disease
  • Adequate organ function within 7 days before starting study treatment, including specified blood counts, kidney function, and liver function
  • Left ventricular ejection fraction (LVEF) of 50% or higher and QTc interval less than or equal to 480 ms on echocardiography
  • Premenopausal or perimenopausal women agreeing to use luteinizing hormone-releasing hormone (LHRH) agonist or meeting defined menopause criteria
  • Women of childbearing potential agree to use effective contraception or abstain from sexual activity during and for 3 months after the study
Not Eligible

You will not qualify if you...

  • Symptomatic visceral metastases, visceral crisis, or deemed inappropriate for endocrine therapy by investigator
  • Past or present central nervous system metastases or leptomeningeal disease
  • Prior use of selective estrogen receptor degraders (SERD), histone deacetylase (HDAC) inhibitors, multi-target tyrosine kinase inhibitors, or PAM pathway inhibitors
  • Known allergy to SERD, entinostat, benzamide-structure drugs, or anlotinib
  • Pregnant or lactating women
  • Coexisting malignant tumors unless fully treated without recurrence or metastasis
  • Pericardial effusion requiring drainage, symptomatic pleural effusion, or ascites
  • Other conditions the investigator considers unsuitable for participation

AI-Screening

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Trial Site Locations

Total: 1 location

1

Zhejiang Cancer Hospital

Zhejiang, Hangzhou, China, 310000

Actively Recruiting

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Research Team

R

Rong Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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