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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 UniversityWinston-Salem, North Carolina  27103
Hartford HospitalHartford, Connecticut  06102-5037
Rocky Mountain Cancer CenterDenver, Colorado  80218
Cancer Centers of the CarolinasGreenville, South Carolina  29605
University of ColoradoDenver, Colorado  80217
Hematology Oncology AssociatesAtlantis, Florida  33462
Florida Cancer SpecialistsFort Myers, Florida  33901
Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
Medical College of GeorgiaAugusta, Georgia  30912
Sarah Cannon Cancer CenterNashville, Tennessee  37203
California Cancer CareGreenbrae, California  94904
Virginia Cancer InstituteRichmond, Virginia  23230
Moffitt Cancer CenterTampa, Florida  33612
Allison Cancer CenterMidland, Texas  79701
Kansas City Cancer CenterKansas City, Missouri  64111
Indiana UniversityIndianapolis, Indiana  46202
Hematology Oncology AssociatesPhoenix, Arizona  85012
Longview Cancer CenterLongview, Texas  75601
Hematology-Oncology Associates of Northern New JerseyMorristown, New Jersey  07962
Puget Sound Cancer CenterEdmonds, Washington  98026
Oncology Hematology CareCincinnati, Ohio  45242
Chattanooga Oncology Hematology AssociatesChattanooga, Tennessee  37404
Cancer Care & Hematology Specialists of ChicagolandNiles, Illinois  60714
Greenebaum Cancer CenterBaltimore, Maryland  21201
South Texas Cancer CenterCorpus Christi, Texas  78405
Columbia Basin Hematology & OncologyKennewicke, Washington  99336
Memorial RegionalHollywood, Florida  
Carolinas HealthcareCharlotte, North Carolina