NCT07441486

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
3mo left

Started Apr 2026

Shorter than P25 for phase_2 breast-cancer

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Apr 2026Aug 2026

First Submitted

Initial submission to the registry

June 11, 2025

Completed
9 months until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Expected
Last Updated

March 2, 2026

Status Verified

June 1, 2025

Enrollment Period

9 days

First QC Date

June 11, 2025

Last Update Submit

February 27, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival (PFS)

    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

Study Arms (1)

Single Arm

EXPERIMENTAL
Drug: EntinostatDrug: Oral Paclitaxel

Interventions

EntinostatDRUG

Entinostat will be administered according to the study protocol.

Single Arm
Oral PaclitaxelDRUG

Oral paclitaxel will be administered according to the study protocol.

Single Arm

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

entinostatPaclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2025

First Posted

March 2, 2026

Study Start

April 1, 2026

Primary Completion

April 10, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

March 2, 2026

Record last verified: 2025-06