Phase II Trial of SAHA & Tamoxifen for Patients With Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

February 28, 2006

Primary Completion Date

April 30, 2011

Study Completion Date

August 31, 2012

Conditions
Breast Cancer
Interventions
DRUG

suberoylanilide hydroxamic acid (SAHA, Vorinostat)

Vorinostat will be used to potentiate the effects of tamoxifen or overcome tamoxifen resistance. All patients will receive vorinostat at 400 mg by mouth (po) daily for 3 out of 4 weeks. Responses will be assessed after 2 cycles (8 weeks + 4 days).

DRUG

tamoxifen citrate (Tamoxifen)

Tamoxifen will be given once daily at 20 mg. Tamoxifen will be given continuously. Responses will be assessed after 2 cycles (8 weeks + 4 days).

Trial Locations (8)

31405

St. Joseph's/Candler, Savannah

32308

Tallahassee Memorial HealthCare, Inc., Tallahassee

32806

M.D. Anderson of Orlando, Orlando

33435

Bethesda Memorial Hospital Research Center, Boynton Beach

33612

H. Lee Moffitt Cancer Center & Research Institute, Tampa

33949

Fawcett Memorial Hospital, Port Charlotte

34994

Martin Memorial Cancer Center, Stuart

94143

University of California, San Francisco

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER

NCT00365599 - Phase II Trial of SAHA & Tamoxifen for Patients With Breast Cancer | Biotech Hunter | Biotech Hunter