Trial Watch: Exemestane With or Without Entinostat in Treating Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic
Important context
- Trial eligibility (participation has strict criteria): Clinical-trial participation has study-specific eligibility criteria; registry listing does not mean a person qualifies or should enroll.
In plain English
The 30-second version
What happened?
ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Active Not Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.
Why does it matter?
Phase 3 trials can contribute later-stage human evidence. CancerDiscoveries can track this record as results and regulatory information emerge.
What does this not prove?
A registered trial is not proof that the intervention works, is not FDA approval for this cancer or use, and is not a clinical-guideline recommendation.
Keep reading for evidence stage, limitations, study details, and sources.
What changed: ClinicalTrials.gov lists Exemestane With or Without Entinostat in Treating Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic (NCT02115282) as a Phase 3 interventional cancer study. The registry status is Active Not Recruiting, with the record last updated 2026-10-22.
Study snapshot: Phase 3; Active Not Recruiting; planned enrollment 608. Conditions listed: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Breast Adenocarcinoma, HER2/Neu Negative. A primary outcome listed by the registry is: Progression-free Survival (PFS).
This entry tracks verified trial-registry facts. Trial registration by itself does not show that an intervention is effective, safe for a particular person, FDA-approved for this use, or recommended by clinical guidelines.
Population / Applicability
Studied in: Participants age 18 Years and older with Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Breast Adenocarcinoma, HER2/Neu Negative who meet the study-specific registry eligibility criteria. (Adults)
Eligibility is study-specific. Registry information does not determine whether any individual should enroll in or receive the intervention.
Full evidence details
- Study design
- Other / not applicable
- Sample size
- 608
- Primary outcome
- Progression-free Survival (PFS)
- Replication
- Unknown
Funding & Conflicts
ClinicalTrials.gov lists the lead sponsor as National Cancer Institute (NCI). Sponsorship is reported for transparency and does not establish efficacy.
Regulatory status by jurisdiction
Unspecified jurisdiction
- Status
- Investigational
- Last verified
- 2026-10-23
Cancer-type scope for this record is not yet recorded.
Guideline positions
Guideline
- Position
- Not addressed
- Last verified
- 2026-10-23
Primary evidence supporting this story
- ClinicalTrials.gov — NCT02115282 (opens in a new tab) (Clinical-trial registry) NCT02115282 Primary source NCT02115282
ClinicalTrials.gov — NCT02115282. NCT02115282.
Last reviewed
Trial Watch: Exemestane With or Without Entinostat in Treating Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic
https://cancerdiscoveries.com/discoveries/trial-watch-exemestane-with-or-without-entinostat-in-treating-patients-with-recurrent-hormone-receptor-positive-breast-cancer-that-is-locally-advanced-or-metastatic/
Research type: Later-Stage Human
What This Means
ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Active Not Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.
What This Doesn't Mean
A registered trial is not proof that the intervention works, is not FDA approval for this cancer or use, and is not a clinical-guideline recommendation.
Why It Matters
Phase 3 trials can contribute later-stage human evidence. CancerDiscoveries can track this record as results and regulatory information emerge.
Important Limitations
- Clinical-trial participation has study-specific eligibility criteria; registry listing does not mean a person qualifies or should enroll.
Primary sources
- ClinicalTrials.gov — NCT02115282 — https://clinicaltrials.gov/study/NCT02115282 (NCT02115282)
Date verified: 2026-10-23
Correction status: No correction or retraction