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

COMPLETEDPHASE2

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

A Phase 2, Randomized, Double-Blind, Multicenter Study of Exemestane With and Without SNDX-275 in Postmenopausal Women With Locally Recurrent or Metastatic Estrogen Receptor-Positive Breast Cancer, Progressing on Treatment With a Non-Steroidal Aromatase Inhibitor

NCT00676663•Syndax Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Postmenopausal female patients
•Histologically or cytologically confirmed estrogen receptor positive (ER+) breast cancer
•Relapsed or progressed on prior treatment with aromatase inhibitor (AI)
•Metastatic disease must be measurable
•Patients receiving palliative radiation at the non-target lesions must have a 2 week wash out period following completion of the treatment prior to enrollment
•Patient may have had one prior chemotherapy as part of first line therapy as long as it was received before initiation of prior AI
•Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 1
•Laboratory parameters: a)Hemoglobin ≥ 9.0 g/dL; platelets ≥ 100.0 x 10\^9/L; Absolute Neutrophil Count (ANC ≥) 1.5 x 10\^9/L without the use of hematopoietic growth factors b)Creatinine less than 2.5 times the upper limit of normal for the institution c)Aspartate transaminase (AST) and alanine transaminase (ALT) less than 2.5 times the upper limit of normal for the institution
•Able to understand and give written informed consent and comply with study procedures

Exclusion Criteria

•Relapse on treatment with non-steroidal AI after less than 12 months for patients in the adjuvant setting
•Progressive disease after less than 3 months treatment with most recent AI for patients with metastatic disease
•Rapidly progressive, life-threatening metastases
•Any palliative radiotherapy to the measurable lesion
•Previous treatment with SNDX-275 or any other histone deacetylase (HDAC) inhibitor including valproic acid
•Allergy to benzamides or inactive components of the study drug
•A history of allergies to any active or inactive ingredients of exemestane
•Any concomitant medical condition that precludes adequate study treatment compliance
•Patient is currently enrolled in (or completed within 30 days before study drug administration) another investigational drug study
•Patient is currently receiving treatment with valproic acid, Zolinza (vorinostat) or any other HDAC inhibitor or deoxyribonucleic acid (DNA) methyltransferase inhibitor or any systemic anticancer treatment (with the exception of Lupron)

Locations (38)

California Cancer Care

Greenbrae, California, United States

Moores UCSD Cancer Center

La Jolla, California, United States

Scripps Health

La Jolla, California, United States

University of Colorado

Aurora, Colorado, United States

Rocky Mountain Cancer Center

Denver, Colorado, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

Memorial Cancer Institute

Hollywood, Florida, United States

University of Southern Florida -Moffitt Cancer Center

Tampa, Florida, United States

Palm Beach Cancer Institute

West Palm Beach, Florida, United States

Medical College of Georgia

Augusta, Georgia, United States

Key Dates

Start Date

June 13, 2008

Primary Completion Date

January 29, 2011

Completion Date

November 26, 2012

Last Updated

May 11, 2022

Enrollment

130

ACTUAL participants

Conditions

Breast CancerEstrogen Receptor-Positive Breast CancerBreast Cancer, Estrogen Receptor-PositiveER+ Breast Cancer

Interventions

entinostat

DRUG

exemestane

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 11, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

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