Vorinostat Before Surgery in Treating Patients With Triple-Negative Breast Cancer
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
Stage II Breast Cancer
Stage IIIA Breast Cancer
Triple-negative Breast Cancer
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Combined PR/ER response [ Time Frame: 21 days ] [ Designated as safety issue: No ]The proportion of patients who achieve sufficient deacetylation of ER and PR will be estimable with a standard error no greater than +/- 0.05. The proportion of patients who exhibit a sufficient change in ER or PR expression can be estimated with similar precision. In addition, paired t-tests and McNamaraÃ¢s test will be used to evaluate whether the effect of vorinostat on deacetylation status or gene expression differs between ER or PR, and linear regression analysis will be used to evaluate the association between deacetylation changes and corresponding expression changes in ER and PR genes.
- Grade 3 or 4 toxicities using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Within 3 days prior to surgery ] [ Designated as safety issue: Yes ]The toxicities observed will be summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity (by NCI Common Toxicity Criteria v4.0 and nadir or maximum values for the laboratory measures), time of onset (i.e. week of treatment), duration, and reversibility or outcome.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (vorinostat and surgery)
Patients receive vorinostat 400 mg daily PO on days 1-21 followed by surgery within 14 days.
Other Names:Procedure: therapeutic conventional surgery
Undergo surgeryOther: laboratory biomarker analysis
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.
Patients receive vorinostat 400 mg daily orally (PO) on days 1-21 followed by surgery within 14 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01695057
|Principal Investigator:||Agustin Garcia||University of Southern California|