Trial · NCT02115594
Phase 2 Study of Fulvestrant With and Without Entinostat in Postmenopausal Women With ER+ Advanced Breast Cancer
NCT02115594, Phase 2, Withdrawn, Syndax Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2 Study of Fulvestrant With and Without Entinostat in Postmenopausal Women With ER+ Advanced Breast Cancer. Trials, record NCT02115594. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02115594
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Study of Fulvestrant With and Without Entinostat in Postmenopausal Women With ER+ Advanced Breast Cancer
- NCT number
- NCT02115594
- Status
- Withdrawn
- Phases
- Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- Syndax Pharmaceuticals
- Conditions
- Breast Cancer
- Interventions
- Fulvestrant, Entinostat, Placebo
- First posted
- 2014-04-16
- Last updated
- 2014-10-08
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival | From date of randomization until the date of 1st documented progression or date of death from any cause, whichever occurs first, assessed for up to 48 months | Radiological disease assessments |
| Secondary | Objective Response Rate (CR or PR) | From date of randomization until the date of 1st documented progression or date of death from any cause, whichever occurs first, for up to 48 months | Radiological disease assessments |
| Secondary | Clinical Benefit Rate (CR, PR, or SD for greater than or equal to 6 months from randomization) | From the date of randomization until the date of 1st documented progression or date of death, from any cause, whichever occurs first, assessed for up to 48 months | Radiological disease assessments |
| Secondary | Overall Survival | From the date of randomization until date of death, assessed for up to 48 months | |
| Secondary | Clinical review of safety parameters (AEs, lab values) | From date of randomization until 30 days post the date of study treatment discontinuation | |
| Secondary | Percent change from baseline in blood protein lysine acetylation measures | From the baseline visit through the 1st 15 days of study treatment | |
| Secondary | Concentrations of entinostat measured in plasma (PK) | From the baseline visit through the 1st 15 days of study treatment | |
| Other | Analysis of biopsy tumor tissue (fresh optional, archival required) | Screening (fresh tissue) and post 1st dose, between Days 15-18 of study treatment | molecular classification of breast cancer (BC) subtypes, DNA methylation, e-cadherin levels, protein lysine acetylation levels, and changes in proteins associated with estrogen signaling and fulvestrant resistance |
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/NCT02115594
GET https://conductscience.org/api/trials/v1/NCT02115594/registered