A Single-arm, Prospective, Phase II Clinical Study of the Combination of Entinostat and Oral Paclitaxel in the Treatment of HR+HER2- Advanced Breast Cancer

February 27, 2026 updated by: Tianjin Medical University Cancer Institute and Hospital
Objective: To explore the curative effect and safty of Changchun Ruibin metronomic chemotherapy combined with endistat in the treatment of HR positive HER2 negative advanced breast carcinoma.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Only participants who meet all of the following eligibility criteria will be eligible for this trial:

  • Age ≥ 18 years;
  • Patients with advanced breast carcinoma confirmed by histopathological and / or cytological examination;
  • HER2-negative breast carcinoma with confirmed HR positive primary and / or metastatic lesions;
  • At least one evaluable tumor lesion (according to RECIST1.1);
  • Prior 2-4 lines of therapy, which must include one endocrine therapy with CDK4 / 6 inhibitors, one chemotherapy with paclitaxel.
  • Previous 1L of ADC drug therapy is acceptable.
  • Complete clinical data on important research indicators;
  • The Eastern Oncology Assistance Group (ECOG) physical fitness status score was 0-2;
  • Life expectancy > 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm
Drug: Entinostat
Entinostat will be administered according to the study protocol.
Drug: Oral Paclitaxel
Oral paclitaxel will be administered according to the study protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Up to 24 months
PFS is defined as the time from first dose to first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 10, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

June 11, 2025

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E20250404

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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