Trial · NCT03538171
Ph3 Study of Exemestane With or Without Entinostat in Chinese Patients With Hormone Receptor-Positive, Locally Advanced or Metastatic Breast Cancer
NCT03538171, Phase 3, Unknown, Taizhou EOC Pharma Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ph3 Study of Exemestane With or Without Entinostat in Chinese Patients With Hormone Receptor-Positive, Locally Advanced or Metastatic Breast Cancer. Trials, record NCT03538171. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03538171
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ph3 Study of Exemestane With or Without Entinostat in Chinese Patients With Hormone Receptor-Positive, Locally Advanced or Metastatic Breast Cancer
- NCT number
- NCT03538171
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 375 participants, actual
- Lead sponsor
- Taizhou EOC Pharma Co., Ltd.
- Conditions
- Advanced Breast Cancer
- Interventions
- Entinostat, Placebo, Exemestane
- First posted
- 2018-05-29
- Last updated
- 2021-07-09
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PFS (The Randomized Double-blinded Part) | From the day of randomization, assessment will be made every 8 weeks (±3 days) to the earliest of documented disease progression (PD) or death caused by any reason (whichever happens first), assessed up to 40 months. | Progression Free Survival, defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). The distribution of PFS will be estimated using the Kaplan- Meier method, with 95% confidence intervals calculated using Greenwood's formula. In the primary analysis of PFS, differences in treatment effect will be tested using stratified log rank tests, stratifying on the randomization stratification factors. Stratified univariate and multivariable Cox proportional-hazard models will be built to estimate the hazard ratios (HRs) for treatment effect for PFS as a supportive analysis. In all analyses, P-values will be two-sided. |
| Secondary | OS (both the Open-label and Randomized Double-blinded parts) | From the day of first administration to the date of death from any cause, assessed up to 48 months. | Overall Survival |
| Secondary | Safety and tolerability (both the Open-label and Randomized Double-blinded parts) | From the first administration of the investigational product to 30 days after the last administration. The Randomized Double-blinded: assessed up to 48 months | Incidence of toxicity graded according to National Cancer Institute CTCAE version 4.0. All treatment-emergent, baseline adverse events and hematological/biochemical toxicities based on laboratory measurements, as well as drug related AEs, will be summarized by both groups. The incidence of deaths and treatment-emergent serious AEs (defined as number of patients experiencing the AE divided by all treated patients) will be summarized and compared between Arm Entinostat+Exemestane and Arm Placebo+Exemestane. Also, the incidence of adverse events leading to discontinuation of investigational product and/or patient's withdrawal from the study will be summarized and listed. |
| Secondary | ORR (both the Open-label and Randomized Double-blinded parts) | From the first administration on Day 1 Run-in Period or randomization day, evaluation will be made every 8 weeks (±3 days), until the earliest of documented PD or death caused by any reason (whichever happens first), assessed up to 48 months. | Objective Response Rate, defined as the proportion of patients with complete response (CR) or partial response (PR) among all patients assessed per RESIST v1.1. Objective response in the two arms will be evaluated by comparing objective response rate (ORR, PR+CR) on the intention-to-treat patients with one-sided type I error of 2.5%. ORR will be summarized along with the exact binomial 95% confidence interval. In all analyses, P-values will be two-sided. |
| Secondary | Pharmacokinetics (The Randomized Double-blinded Part) | Cycle 1 Day 1, within 3h and 5h after the administration; Cycle 1 Day 15,1h after the administration; Cycle 2 Day 1, within 72h prior to administration. | Time at which maximum plasma concentration was observed. |
| Secondary | CBR (both the Open-label and Randomized Double-blinded parts) | Estimated per 8 weeks (±3 days) from the first administration of the investigational product on Day 1 Run-in Period or randomization day, to the earliest of documented PD or death caused by any reason (whichever happens first),assessed up to 48 months. | Clinical Benefit Rate, defined as CR+PR+SD≥ 24 weeks |
| Other | PBMC acetylation | Cycle 1 Day 1, prior to administration; ; Cycle 2 Day 1, prior to administration. | To evaluate whether the efficacy of exemestane with entinostat varies with changes in acetylation status in peripheral blood mononuclear cells (PBMCs). |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37250148 | DERIVED |
Source PubMed
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/NCT03538171
GET https://conductscience.org/api/trials/v1/NCT03538171/registered