NCT00262834

Vorinostat in Treating Women Who Are Undergoing Surgery For Newly Diagnosed Stage I -III Breast Cancer

A Pilot Study Evaluating Surrogates of Response to Short Term Oral Suberoylanilide Hydroxamic Acid (SAHA) in Women With Newly Diagnosed Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well vorinostat works in treating women who are undergoing surgery for newly diagnosed stage I, stage II, or stage III breast cancer. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat before surgery may shrink the tumor so that it can be removed.

Detailed description

PRIMARY OBJECTIVE: I. Determine the safety and tolerability of vorinostat in women undergoing conventional surgery for newly diagnosed stage I-III breast cancer. OULINE: This is a multicenter, pilot study. Patients receive oral vorinostat twice daily on days -3 to 0. Approximately 2 hours after the final dose of vorinostat, patients undergo surgical resection of the tumor on day 0. After completion of study treatment, patients are followed for 30 days.

Conditions

• Breast Cancer
• Stage I Breast Cancer
• Stage II Breast Cancer
• Stage III Breast Cancer

Interventions

Type	Name	Description
DRUG	vorinostat	Given orally, conventional surgery to follow.
OTHER	conventional surgery	Undergo conventional surgery

Timeline

• Start date: 2005-10-01
• Primary completion: 2008-10-01
• Completion: 2013-05-01
• First posted: 2005-12-07
• Last updated: 2020-02-19
• Results posted: 2014-09-08

Locations

1 site across 1 country: United States