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.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Inclusion Criteria:
- Postmenopausal female patients
- Histologically or cytologically confirmed ER+ breast cancer
- Relapsed or progressed on prior treatment with 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
- ECOG performance status: 0 to 1
- Laboratory parameters: a)Hemoglobin ≥ 9. 0 g/dL; platelets ≥ 100. 0 x 109/L; ANC ≥ 1. 5
x 109/L without the use of hematopoietic growth factors b)Creatinine less than 2. 5
times the upper limit of normal for the institution c)AST and 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 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 DNA methyltransferase inhibitor or any systemic
anticancer treatment (with the exception of Lupron)
Fakultni nemocnice Olomouc, Olomouc, Czech Republic
Radiologicke centrum Multiscan, s.r.o., Pardubice, Czech Republic
Fac Hospital Kralovske, Praque, Czech Republic
National Health Centre of Hungary, Budapest, Hungary
Semmelweis Egyetem, Budapest, Hungary
Radiologicke centrum Multiscan, Debrecen, Hungary
Borsod-Abaus Zemplen County Hospital, Miskolc, Hungary
Clinfan Ltd SMO, County Hospital Szekszard, Szekszárd, Hungary
Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation
Blokhin Russian Oncology Research Center of Russian Academy of Medical Sciences, Moscow, Russian Federation
Murmansk Regional Clinical Oncology Dispensary, Murmansk, Russian Federation
Leningrad Regional Oncology Dispensary, Saint-Petersburg, Russian Federation
Stavropol Territory Clinical Oncology Dispensary, Stavropol, Russian Federation
Hematology Oncology Associates, Phoenix, Arizona, United States
California Cancer Care, Greenebrae, California, United States
Moores UCSD Cancer Center, La Jolla, California, United States
University of Colorado, Aurora, Colorado, United States
Rocky Mountain Cancer Center, Denver, Colorado, United States
Hartford Hospital, Hartford, Connecticut, United States
Florida Cancer Specialists, Fort Myers, Florida, United States
Memorial Regional, Hollywood, Florida, United States
Hematology Oncology Associates, Lake Worth, Florida, United States
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
Cancer Care & Hematology Specialists of Chicagoland, Niles, Illinois, United States
Indiana University, Indianapolis, Indiana, United States
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, Charlotte, North Carolina, United States
Wake Forest University, Winston-Salem, North Carolina, United States
Oncology Hematology Care, Cincinnati, Ohio, United States
RSM Durham Regional Cancer Center - Lakeridge Health, Oshawa, Ontario, Canada
St. Joseph's Health Centre, Toronto, Ontario, Canada
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
Longview Cancer Center, Longview, Texas, United States
South Texas Cancer Center, McAllen, Texas, United States
Allison Cancer Center, Midland, 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