NCT01695057

Vorinostat Before Surgery in Treating Patients With Triple-Negative Breast Cancer

A Pilot Clinical Trial to Evaluate the Biological Activity of HDAC (Histone Deacetylase Transferases) Inhibition on ER and PR Expression in Triple Negative Invasive Breast Cancer

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies vorinostat before surgery in treating patients with triple-negative breast cancer. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving enzyme inhibitor therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the ability of histone deacetylase (HDAC) inhibition using suberoylanilide hydroxamic acid (SAHA) (vorinostat) to induce expression of the estrogen receptor (ER) and progesterone receptor (PR) genes in solid human triple negative invasive breast cancer. OUTLINE: Patients receive vorinostat 400 mg daily orally (PO) on days 1-21 followed by surgery within 14 days.

Conditions

• Stage II Breast Cancer
• Stage IIIA Breast Cancer
• Triple-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	vorinostat	Given PO
PROCEDURE	therapeutic conventional surgery	Undergo surgery
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-10-01
• Completion: 2015-10-01
• First posted: 2012-09-27
• Last updated: 2014-01-28