OncRef

Clinical Trial: NCT02115282

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-10-01

Study Overview

Brief 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.

Official Title

A Randomized Phase III Trial of Endocrine Therapy Plus Entinostat/Placebo in Patients With Hormone Receptor-Positive Advanced 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

Intervention / Treatment

  • Procedure: Biospecimen Collection
  • Procedure: Computed Tomography
  • Drug: Entinostat
  • Drug: Exemestane
  • Drug: Goserelin
  • Drug: Goserelin Acetate
  • Procedure: Magnetic Resonance Imaging
  • Other: Placebo Administration
  • Other: Quality-of-Life Assessment

Other Study ID Numbers

  • NCI-2014-00746
  • NCI-2014-00746
  • ECOG-E2112
  • E2112
  • E2112
  • U10CA021115
  • U10CA180820
  • U24CA196172

Start Date (Actual)

2014-03-29

Primary Completion Date (Actual)

2020-05-05

Study Completion Date (Estimated)

2027-06-02

Enrollment (Actual)

608

Study Type

Interventional

Phase

Phase 3