Study to Evaluate Exemestane With and Without Entinostat (SNDX-275) in Treatment of Postmenopausal Women With Advanced Breast Cancer
ENCORE301
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
2 other identifiers
interventional
130
5 countries
38
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Jun 2008
Typical duration for phase_2 breast-cancer
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2008
CompletedFirst Posted
Study publicly available on registry
May 13, 2008
CompletedStudy Start
First participant enrolled
June 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 26, 2012
CompletedResults Posted
Study results publicly available
October 24, 2019
CompletedMay 11, 2022
April 1, 2022
2.6 years
May 9, 2008
October 24, 2018
April 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS)
PFS is defined as the number of months from the date of randomization to the earlier of progressive disease (PD) or death due to any cause.
From date of randomization to discontinuation due to disease progression or death up to primary completion date (Median follow-up 6 months)
Secondary Outcomes (3)
Objective Response Rate (ORR)
From date of randomization to discontinuation due to disease progression or intolerable Adverse Event (AE) up to primary completion date (Median follow-up 6 months)
Clinical Benefit Rate (CBR)
From date of randomization to discontinuation due to disease progression or intolerable AE up to primary completion date (Median follow-up 6 months)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
First dose to within 30 days of last dose of study drug (Up to Approximately 2 Years)
Other Outcomes (1)
Overall Survival (OS)
First dose of study drug to end of study (Median follow-up 24 months in the EE arm and 26.4 months in the EP arm)
Study Arms (2)
Exemestane 25 mg + Entinostat 5 mg
EXPERIMENTALExemestane (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.
Exemestane 25 mg + Placebo
PLACEBO COMPARATORExemestane (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.
Interventions
Entinostat 5 mg tablet orally once per week
Exemestane 25 mg tablet orally once daily
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
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
Related Publications (1)
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.
PMID: 23650416DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kate Madigan, MD, Chief Medical Officer
- Organization
- Syndax Pharmaceuticals, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Denise Yardley, MD
Sarah Cannon Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2008
First Posted
May 13, 2008
Study Start
June 13, 2008
Primary Completion
January 29, 2011
Study Completion
November 26, 2012
Last Updated
May 11, 2022
Results First Posted
October 24, 2019
Record last verified: 2022-04