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

Stage IIIA Breast Cancer Clinical Trial

Official title: 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Status Withdrawn

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

• NCT number: NCT01695057
• Study type: Interventional
• Source: University of Southern California
• Status: Withdrawn
• Phase: N/A
• Start date: October 2012
• Completion date: October 2015