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A Ph 2, Randomized, Double-Blind, Multicenter Study of Exemestane +/- Entinostat in Postmenopausal Women With Locally Recurrent or Metastatic ER+ Breast Cancer, Progressing on Treatment With a Non-Steroidal AI


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Estrogen Receptor-Positive Breast Cancer, Breast Cancer, Estrogen Receptor-Positive, ER+ Breast Cancer

Thank you

Trial Information

A Ph 2, Randomized, Double-Blind, Multicenter Study of Exemestane +/- Entinostat in Postmenopausal Women With Locally Recurrent or Metastatic ER+ Breast Cancer, Progressing on Treatment With a Non-Steroidal AI


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

To compare the efficacy of exemestane alone with exemestane plus entinostat, as determined by the duration of progression free survival (PFS) measured from the date of randomization.

Outcome Time Frame:

from date of randomization to discontinuation due to disease progression or intolerable AE

Safety Issue:

No

Principal Investigator

Denise Yardley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

SNDX-275-0301

NCT ID:

NCT00676663

Start Date:

May 2008

Completion Date:

December 2012

Related Keywords:

  • Breast Cancer
  • Estrogen Receptor-positive Breast Cancer
  • Breast Cancer, Estrogen Receptor-Positive
  • ER+ Breast Cancer
  • Breast Neoplasms
  • Breast Tumor
  • Mammary Neoplasms
  • Breast Neoplasms

Name

Location

Wake Forest University Winston-Salem, North Carolina  27103
Hartford Hospital Hartford, Connecticut  06102-5037
Rocky Mountain Cancer Center Denver, Colorado  80218
Cancer Centers of the Carolinas Greenville, South Carolina  29605
University of Colorado Denver, Colorado  80217
Hematology Oncology Associates Atlantis, Florida  33462
Florida Cancer Specialists Fort Myers, Florida  33901
Moores UCSD Cancer Center La Jolla, California  92093-0658
Palm Beach Cancer Institute West Palm Beach, Florida  33401
Medical College of Georgia Augusta, Georgia  30912
Sarah Cannon Cancer Center Nashville, Tennessee  37203
California Cancer Care Greenbrae, California  94904
Virginia Cancer Institute Richmond, Virginia  23230
Moffitt Cancer Center Tampa, Florida  33612
Allison Cancer Center Midland, Texas  79701
Kansas City Cancer Center Kansas City, Missouri  64111
Indiana University Indianapolis, Indiana  46202
Hematology Oncology Associates Phoenix, Arizona  85012
Longview Cancer Center Longview, Texas  75601
Hematology-Oncology Associates of Northern New Jersey Morristown, New Jersey  07962
Puget Sound Cancer Center Edmonds, Washington  98026
Oncology Hematology Care Cincinnati, Ohio  45242
Chattanooga Oncology Hematology Associates Chattanooga, Tennessee  37404
Cancer Care & Hematology Specialists of Chicagoland Niles, Illinois  60714
Greenebaum Cancer Center Baltimore, Maryland  21201
South Texas Cancer Center Corpus Christi, Texas  78405
Columbia Basin Hematology & Oncology Kennewicke, Washington  99336
Memorial Regional Hollywood, Florida  
Carolinas Healthcare Charlotte, North Carolina