Clinical trialNCT02115282Active, not recruitingPhase 3Interventional

Exemestane With or Without Entinostat in Treating Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic

SponsorNational Cancer Institute (NCI)Enrollment608Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Breast AdenocarcinomaHER2/Neu NegativeLocally Advanced Breast CarcinomaMetastatic Breast Carcinoma+1 more conditions

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Roisin M Connolly
ECOG-ACRIN Cancer Research Group
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

653 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

South Africa

University of Pretoria
Pretoria, South Africa

United States

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Nea Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States
Mercy San Juan Medical Center
Carmichael, California, United States
Adventist Health Cancer Care Center Chico
Chico, California, United States
Enloe Medical Center
Chico, California, United States
Community Cancer Institute
Clovis, California, United States
University Oncology Associates
Clovis, California, United States
Eisenhower Medical Center
Rancho Mirage, California, United States
Mercy Cancer Center - Sacramento
Sacramento, California, United States
Saint Helena Hospital
St. Helena, California, United States
Presbyterian Intercommunity Hospital
Whittier, California, United States
Woodland Memorial Hospital
Woodland, California, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, United States
the Medical Center of Aurora
Aurora, Colorado, United States
Boulder Community Foothills Hospital
Boulder, Colorado, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, United States
Uchealth Memorial Hospital Central
Colorado Springs, Colorado, United States
Adventhealth Porter
Denver, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, United States
Commonspirit Cancer Center Mercy
Durango, Colorado, United States
Mercy Medical Center
Durango, Colorado, United States
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Mountain Blue Cancer Care Center
Golden, Colorado, United States
Banner North Colorado Medical Center
Greeley, Colorado, United States
Rocky Mountain Cancer Centers-Greenwood Village
Greenwood Village, Colorado, United States
Commonspirit Saint Anthony Hospital Cancer Center
Lakewood, Colorado, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, United States
Adventhealth Littleton
Littleton, Colorado, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, United States
Sky Ridge Medical Center
Lone Tree, Colorado, United States

613 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

EntinostatExemestane →Goserelin →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 29 Mar 2014
Primary completion: 5 May 2020
Completion: 2 Jun 2027
Last update posted: 4 Aug 2026
Registered enrollment: 608
Registry id: NCT02115282

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.