NCT00365599

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

Phase II Trial of Suberoylanilide Hydroxamic Acid (SAHA, Vorinostat) in Combination With Tamoxifen for Patients With Advanced Breast Cancer Who Have Failed Prior Anti-hormonal Therapy.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II trial to explore the efficacy of vorinostat and tamoxifen combined.

Detailed description

Phase II trial to explore the efficacy of vorinostat and tamoxifen combined. Tamoxifen will be given once daily, continuously. Vorinostat will be given daily for 3 out of 4 weeks (a cycle). Responses will be assessed (restaged) after 2 cycles and toxicities will be captured continuously. Eligible patients will receive treatment in consecutive 4-week cycles, until progression of disease or unacceptable toxicity. Patients will be followed for evaluation of safety for at least 30 days after the last dose of the study drug. Tests will be obtained pre-and post vorinostat treatment and correlated with plasma levels of vorinostat at the time of tumor biopsy and vorinostat doses; the tests will consist of: * Patient history * Physical exam (including height and weight) * Toxicity assessment * Pharmacokinetic (PK) sample * Tumor fine needle aspirate (FNA) * Peripheral Blood Mononuclear Cells (PBMC) * Standard labs and Chemistry Profile * Carcinoembryonic antigen (CEA), cancer antigen (Ca) 15-3, Ca 125 (If clinically indicated) * Pregnancy Test * Computed tomography (CT) scans, and magnetic resonance imaging (MRI) Documentation of response and progression will be evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2006-02-01
• Primary completion: 2011-04-01
• Completion: 2012-08-01
• First posted: 2006-08-17
• Last updated: 2014-11-21
• Results posted: 2012-03-26

Locations

8 sites across 1 country: United States