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NCT02115282 · ClinicalTrials.gov registry record · Phase 3
Exemestane With or Without Entinostat in Treating Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic
A Phase 3 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 608
- Enrollment target
- 20
- Study locations
NCT02115282: Active Phase 3 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
NCT02115282 is a Phase 3 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 608 participants, above the 298-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (104% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02115282, a Phase 3 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 608 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial studies exemestane and entinostat to see how well they work compared to exemestane alone in treating patients with hormone receptor-positive breast cancer that has spread to nearby tissue or lymph nodes (locally advanced) or another place in the body (metastatic). Estrogen can cause the growth of breast cancer cells. Endocrine therapy using exemestane may fight breast cancer by lowering the amount of estrogen the body makes. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether exemestane is more effective with or without entinostat in treating breast cancer.
Primary Outcome
Progression-free survival (PFS) was defined to be time from randomization to the earliest documented disease progression as defined by the RECIST criteria, new primary breast cancer, or death without progression. Disease assessment was to continue until disease progression, even after non-protocol anti-cancer therapy was started. Cases with incomplete follow up or without adequate disease evaluations were censored at the date last documented to be free of progression, regardless of whether non-p
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Exemestane
- DRUG Goserelin
- DRUG Entinostat
Study Locations (20)
California
- Mercy San Juan Medical Center - Carmichael
- Enloe Medical Center - Chico
- Adventist Health Cancer Care Center Chico - Chico
- Community Cancer Institute - Clovis
- University Oncology Associates - Clovis
- Eisenhower Medical Center - Rancho Mirage
- Mercy Cancer Center - Sacramento - Sacramento
- Saint Helena Hospital - St. Helena
- Presbyterian Intercommunity Hospital - Whittier
- Woodland Memorial Hospital - Woodland
Colorado
- Rocky Mountain Cancer Centers-Aurora - Aurora
- The Medical Center of Aurora - Aurora
- Boulder Community Foothills Hospital - Boulder
- Rocky Mountain Cancer Centers-Boulder - Boulder
- Penrose-Saint Francis Healthcare - Colorado Springs
- Rocky Mountain Cancer Centers-Penrose - Colorado Springs
- UCHealth Memorial Hospital Central - Colorado Springs
- AdventHealth Porter - Denver
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Arkansas
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 608 participants |
| Start Date | 2014-03-29 |
| Est. Completion | 2026-06-02 |
| Phase | Phase 3 |
What the registry record for NCT02115282 still lists
NCT02115282 is an interventional study that assigns participants to a tested intervention. The registered 608 participants enrollment target is mid-sized for trials with a published cap, above the 298-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (104% higher).
The record links to 7 conditions, with Anatomic Stage III Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT02115282 names 20 study sites across 4 states, led by California, Colorado, Alabama.
Frequently Asked Questions
What is clinical trial NCT02115282 about?
NCT02115282 is a clinical study titled "Exemestane With or Without Entinostat in Treating Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic". This randomized phase III trial studies exemestane and entinostat to see how well they work compared to exemestane alone in treating patients with hormone receptor-positive breast cancer that has spread to nearby tissue or lymph nodes (locally advanced) or another place in the body (metastatic). Est...
What is the current status of trial NCT02115282?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 608 participants. The study started on 2014-03-29. Estimated completion is 2026-06-02.
What conditions does trial NCT02115282 study?
This clinical trial studies the following conditions: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Recurrent Breast Carcinoma, HER2/Neu Negative.
What interventions are being tested in trial NCT02115282?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Exemestane (DRUG), Goserelin (DRUG), Entinostat (DRUG).
Who is sponsoring clinical trial NCT02115282?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02115282 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02115282's enrollment target sits among peer trials
608 12th of 84 higher than 73 of 84 other Anatomic Stage III Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage III Breast Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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