Study to Evaluate Exemestane With and Without Entinostat (SNDX-275) in Treatment of Postmenopausal Women With Advanced Breast Cancer
NCT ID: NCT00676663
Last Updated: 2022-05-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
130 participants
INTERVENTIONAL
2008-06-13
2012-11-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Exemestane 25 mg + Entinostat 5 mg
Exemestane (Aromasin®) 25 mg tablets orally once daily plus an entinostat 5 mg tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
entinostat
Entinostat 5 mg tablet orally once per week
exemestane
Exemestane 25 mg tablet orally once daily
Exemestane 25 mg + Placebo
Exemestane (Aromasin®) 25 mg tablets orally once daily plus a placebo-matching entinostat tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
exemestane
Exemestane 25 mg tablet orally once daily
Placebo
Placebo-matching entinostat tablet orally once per week
Interventions
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entinostat
Entinostat 5 mg tablet orally once per week
exemestane
Exemestane 25 mg tablet orally once daily
Placebo
Placebo-matching entinostat tablet orally once per week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
FEMALE
No
Sponsors
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Syndax Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Denise Yardley, MD
Role: PRINCIPAL_INVESTIGATOR
Sarah Cannon Cancer Center
Locations
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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
St. Joseph's Health Centre
Toronto, Ontario, Canada
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Radiologicke centrum Multiscan, s.r.o.
Pardubice, , Czechia
Fakultani Nemocnice Kralavske Vinohadry
Praque, , Czechia
Allami Egeszseguegi Koezpont
Budapest, , Hungary
Semmelweis Egyetem
Budapest, , Hungary
Radiologicke centrum Multiscan
Debrecen, , Hungary
Clinfan Ltd SMO, County Hospital Szekszard
Szekszárd, , Hungary
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk, , Russia
Blokhin Russian Oncology Research Center of Russian Academy of Medical Sciences
Moscow, , Russia
Leningrad Regional Oncology Dispensary
Saint Petersburg, , Russia
Russian Research Centre of Radiology and Surgery
Saint Petersburg, , Russia
Stavropol Territory Clinical Oncology Dispensary
Stavropol, , Russia
Countries
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References
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Yardley DA, Ismail-Khan RR, Melichar B, Lichinitser M, Munster PN, Klein PM, Cruickshank S, Miller KD, Lee MJ, Trepel JB. Randomized phase II, double-blind, placebo-controlled study of exemestane with or without entinostat in postmenopausal women with locally recurrent or metastatic estrogen receptor-positive breast cancer progressing on treatment with a nonsteroidal aromatase inhibitor. J Clin Oncol. 2013 Jun 10;31(17):2128-35. doi: 10.1200/JCO.2012.43.7251. Epub 2013 May 6.
Other Identifiers
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2009-012623-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SNDX-275-0301
Identifier Type: -
Identifier Source: org_study_id
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