Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 14 of 14

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.
Other	Relationship of circulating tumor cells 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 cells. This will be used to describe the relationship between circulating tumor cells and residual disease at the time of surgery.
Other	Levels of circulating tumor DNA	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 any changes in the levels prior to and following treatment.
Other	Relationship of circulating tumor DNA and disease-free survival	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 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 disease-free survival.
Other	Relationship of circulating tumor cells and disease-free survival	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 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 cells. This will be used to describe the relationship between circulating tumor cells and disease-free survival.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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