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NCT Number: NCT07441486

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Entinostat

Drug

Entinostat will be administered according to the study protocol.

Oral Paclitaxel

Drug

Oral paclitaxel will be administered according to the study protocol.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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