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Study to Evaluate Exemestane With and Without Entinostat (SNDX-275) in Treatment of Postmenopausal Women With Advanced Breast Cancer

NCT00676663 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2022-05-11

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of entinostat in combination with exemestane in the treatment of advanced breast cancer.

Conditions

  • Breast Cancer
  • Estrogen Receptor-Positive Breast Cancer
  • Breast Cancer, Estrogen Receptor-Positive
  • ER+ Breast Cancer

Interventions

DRUG

entinostat

Entinostat 5 mg tablet orally once per week

DRUG

exemestane

Exemestane 25 mg tablet orally once daily

DRUG

Placebo

Placebo-matching entinostat tablet orally once per week

Sponsors & Collaborators

Principal Investigators

  • Denise Yardley, MD · Sarah Cannon Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-13
Primary Completion
2011-01-29
Completion
2012-11-26
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Czechia
  • Hungary
  • Russia

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00676663 on ClinicalTrials.gov