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
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
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Combined PR/ER response
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.
USC/Norris Comprehensive Cancer Center
United States: Institutional Review Board