Trial · NCT03473639
A Pilot Study of the Combination of Entinostat With Capecitabine in High Risk Breast Cancer After Neo-adjuvant Therapy
NCT03473639, Phase 1, Completed, University of Virginia
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Pilot Study of the Combination of Entinostat With Capecitabine in High Risk Breast Cancer After Neo-adjuvant Therapy. Trials, record NCT03473639. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03473639
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pilot Study of the Combination of Entinostat With Capecitabine in High Risk Breast Cancer After Neo-adjuvant Therapy
- NCT number
- NCT03473639
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 13 participants, actual
- Lead sponsor
- University of Virginia
- Conditions
- Metastatic Breast Cancer, Breast Cancer
- Interventions
- Entinostat, Capecitabine
- First posted
- 2018-03-22
- Last updated
- 2022-11-01
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Identification of a maximum tolerated dose combination (MTDC) of entinostat and capecitabine | During the first cycle of treatment (each cycle is 21 days) for each participant | This will be defined based on the number of "dose limiting toxicities" in participants at each dose level. |
| Primary | Frequency of adverse events (AEs) in participants with high-risk breast cancer after neo-adjuvant therapy | AEs from consent through 30 days following stopping study treatment. Study treatment-related serious adverse events (SAEs) anytime | Frequency of adverse events (AEs) in participants with high-risk BC after neo-adjuvant therapy at the determined MTDC. |
| Primary | Severity (as graded with the Common Terminology Criteria for Adverse Events (CTCAE)) of adverse events (AEs) in participants with high-risk breast cancer after neo-adjuvant therapy | AEs from consent through 30 days following stopping study treatment. Study treatment-related serious adverse events (SAEs) anytime | Severity of adverse events (AEs) in participants with high-risk BC after neo-adjuvant therapy at the determined MTDC. |
| Secondary | Frequency of adverse events (AEs) in MBC participants at the determined MTDC. | AEs from consent through 30 days following stopping study treatment. Study treatment-related serious adverse events (SAEs) anytime | Adverse events (AEs) will be assessed via the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 in MBC participants at the determined MTDC. |
| Secondary | Disease-free survival (DFS) | Participants will be followed for up to 10 years following completion of study therapy | Disease-free survival (DFS) following combination therapy with entinostat and capecitabine |
| Secondary | Severity (as graded with the Common Terminology Criteria for Adverse Events (CTCAE)) of adverse events (AEs) in MBC participants | AEs from consent through 30 days following stopping study treatment. Study treatment-related serious adverse events (SAEs) will be collected starting at consent and continuing for the life of the study. | Adverse events (AEs) will be graded via the CTCAE version 4.03 in MBC participants at the determined MTDC. |
| Secondary | Frequency of adverse events (AEs) and dose-limiting toxicities (DLTs) in participants on both arms of the study at the determined MTDC. | DLTs will be identified during the 1st cycle (each cycle is 21 days) of study treatment. AEs from consent through 30 days following completion of treatment. Study treatment-related SAEs will be collected starting at consent through end of study | Adverse events (AEs) will be assessed via the CTCAE version 4.03 in participants on both arms of the study at the determined MTDC. |
| Secondary | Severity (as graded with the CTCAE) of adverse events (AEs) in participants on both arms of the study at the determined MTDC | DLTs will be identified during the 1st cycle (each cycle is 21 days) of study treatment. AEs from consent through 30 days following completion of treatment. Study treatment-related SAEs will be collected starting at consent through end of study | Adverse events (AEs) will be graded via the CTCAE version 4.03 in participants on both arms of the study at the determined MTDC. |
| Other | Overall survival | Up to 10 years following completion of study treatment for each participant | Participants will be followed annually following completion of study treatment |
| Other | Relationship of circulating tumor DNA and residual disease | Before and after study treatment (unless treatment is stopped early for safety, disease progression/recurrence, or subject or investigator decision, treatment will last 8 cycles of 21 days each) for each participant with high-risk BC following surgery | For participants with high risk BC after neo-adjuvant therapy, blood will be collected prior to treatment and at end of treatment and tested for levels of circulating tumor DNA. This will be used to describe the relationship between circulating tumor DNA and residual disease at the time of surgery. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
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 |
|---|---|
| 38356965 | 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/NCT03473639
GET https://conductscience.org/api/trials/v1/NCT03473639/registered