Vorinostat Before Surgery in Treating Patients With Triple-Negative Breast Cancer
|ClinicalTrials.gov Identifier: NCT01695057|
Recruitment Status : Withdrawn (Lack of funding)
First Posted : September 27, 2012
Last Update Posted : January 28, 2014
|Condition or disease||Intervention/treatment||Phase|
|Stage II Breast Cancer Stage IIIA Breast Cancer Triple-negative Breast Cancer||Drug: vorinostat Procedure: therapeutic conventional surgery Other: laboratory biomarker analysis||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||October 2014|
|Estimated Study Completion Date :||October 2015|
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
- Combined PR/ER response [ Time Frame: 21 days ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695057
|Principal Investigator:||Agustin Garcia||University of Southern California|