NCT00132002

Suberoylanilide Hydroxamic Acid in Treating Patients With Progressive Stage IV Breast Cancer

Phase II Study of Suberoylanilide Hydroxamic Acid (SAHA) (NSC 701852) as Salvage Therapy in Metastatic Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating patients with progressive stage IV breast cancer. Drugs used in chemotherapy, such as suberoylanilide hydroxamic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the response rate in patients receiving SAHA for stage IV breast cancer. SECONDARY OBJECTIVES: I. Time to progression. II. Overall survival. III. Toxicity profile. IV. Assessment of potential biological correlates. OUTLINE: This is a multicenter study. Patients receive oral suberoylanilide hydroxamic acid twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 8 weeks.

Conditions

• Male Breast Cancer
• Recurrent Breast Cancer
• Stage IV Breast Cancer

Interventions

Type	Name	Description
DRUG	vorinostat	Given PO
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2005-06-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2005-08-19
• Last updated: 2015-03-19
• Results posted: 2015-03-19

Locations

1 site across 1 country: United States