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

NCT02115282 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 608

Last updated 2026-04-30

Study results available
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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.

Conditions

  • Anatomic Stage III Breast Cancer AJCC v8
  • Anatomic Stage IV Breast Cancer AJCC v8
  • Breast Adenocarcinoma
  • HER2/Neu Negative
  • Locally Advanced Breast Carcinoma
  • Metastatic Breast Carcinoma
  • Recurrent Breast Carcinoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood and archived tissue samples

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Entinostat

Given PO

DRUG

Exemestane

Given PO

DRUG

Goserelin

Given PO

DRUG

Goserelin Acetate

Given SC

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

OTHER

Placebo Administration

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Roisin M Connolly · ECOG-ACRIN Cancer Research Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-29
Primary Completion
2020-05-05
Completion
2026-06-02

Countries

  • United States
  • South Africa

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02115282 on ClinicalTrials.gov