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

Completed · Phase 2 · Has a placebo group

Conditions studied: Breast Cancer, Estrogen Receptor-Positive Breast Cancer, Breast Cancer, Estrogen Receptor-Positive, ER+ Breast Cancer

In brief

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.

Key facts

Study ID

NCT00676663

Run by

Syndax Pharmaceuticals

People needed

130

Starts

2008-06-13

Expected to finish

2012-11-26

Last updated by the study team

2022-05-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• 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
• Indiana University Indiana Cancer Pavilion — Indianapolis, Indiana, United States
• University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States
• Kansas City Cancer Center — Kansas City, Missouri, United States
• Hematology-Oncology Associates of Northern New Jersey — Morristown, New Jersey, United States
• Carolinas Healthcare System Clinical Trials — Charlotte, North Carolina, United States
• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
• Oncology Hematology Care — Cincinnati, Ohio, United States
• Cancer Centers of the Carolinas — Greenville, South Carolina, United States
• Chattanooga Oncology Hematology Associates — Chattanooga, Tennessee, United States
• Sarah Cannon Cancer Center — Nashville, Tennessee, United States
• South Texas Cancer Center — McAllen, Texas, United States
• Virginia Cancer Institute — Richmond, Virginia, United States
• Columbia Basin Hematology & Oncology — Kennewick, Washington, United States
• Puget Sound Cancer Center — Seattle, Washington, United States
• RSM Durham Regional Cancer Center - Lakeridge Health — Oshawa, Ontario, Canada

Full record on ClinicalTrials.gov

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