Trial · NCT07235618
A Study of Entinostat in Combination With Fulvestrant for the Treatment of Locally Advanced or Metastatic Breast Cancer
NCT07235618, Phase 2, Not yet recruiting, Sun Yat-sen University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Entinostat in Combination With Fulvestrant for the Treatment of Locally Advanced or Metastatic Breast Cancer. Trials, record NCT07235618. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07235618
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Entinostat in Combination With Fulvestrant for the Treatment of Locally Advanced or Metastatic Breast Cancer
- NCT number
- NCT07235618
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 50 participants, estimated
- Lead sponsor
- Sun Yat-sen University
- Conditions
- Locally Advanced or Metastatic Breast Cancer
- Interventions
- Entinostat, Fulvestrant
- First posted
- 2025-11-19
- Last updated
- 2025-11-19
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | Up to 1 year | Progression-free survival(PFS) is defined as the time from treatment initiation to disease progression or death from any cause. |
| Secondary | Overall Survival(OS) | Up to 3 years | Overall survival (OS) is defined as the time from treatment initiation to death from any cause. |
| Secondary | Objective Response Rate(ORR) | Up to 3 years | Objective response rate (ORR) is defined as the percetage of participants achieving a complete response (CR) or partial response (PR) according to RECIST v.1.1. |
| Secondary | Clinical Benefit Rate(CBR) | Up to 3 years | Clinical Benefit Rate(CBR) is defined as the percetage of participants achieving a complete response (CR) and partial response (PR) and stable disease （SD）≥ 24 weeks according to RECIST v.1.1. |
| Secondary | Duration of response(DOR) | Up to 3 years | Duration of response (DOR) is defined as the duration from response initiation (when either CR or PR ) to progression or death, whichever occurs first. |
| Secondary | Health-Related Quality of Life | Up to 3 years | Quality of life measures will be assessed at baseline, the 28th day of the first cycle the 28th day of the fourth cycle, and the 28th day of each subsequent cycle, at the end of the treatment and will be collected using patient reported outcome questionnaires: Cancer Treatment Function Evaluation System - Breast Cancer (FACT-B) |
| Secondary | Treatment compliance | Up to 3 years | The proportion of high, medium and low adherence to each drug will be calculated along with the binomial exact 95% confidence interval. |
| Secondary | Number of participants with adverse events | Up to 3 years | Adverse events are assessed by CTCAE v5.0 |
| Other | Biomarker analysis(protein lysine acetylation of peripheral blood samples (PBMCs)) | Up to 1 year | Protein lysine acetylation of peripheral blood samples (PBMCs) will be assessed at baseline, the first day of the first cycle,the 15th day of the first cycle, the first day of the fourth cycle, and the 15th day of fourth cycle, at the end of the treatmentthe fourth cycle, and the 15th day of fourth cycle, at the end of the treatment |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07235618
GET https://conductscience.org/api/trials/v1/NCT07235618/registered