Trial for Locally Advanced Breast Cancer Using Vorinostat Plus Chemotherapy
Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
Participant gender:
Summary
Vorinostat is a histone deacetylase (HDAC) inhibitor which is approved by the U.S. Food and
Drug Administration for the treatment of a rare type of cancer involving the skin (cutaneous
T cell lymphoma), but not for breast cancer. HDAC inhibitors work by unsilencing tumor
suppressor genes and other genes in the cancer cells that are repressed; when the genes are
turned back on by the drug, it leads to death of the cancer cells. HDAC inhibitors such as
vorinostat have been shown to enhance the effects of chemotherapy and trastuzumab in
experimental systems. The purpose of this trial is to determine the optimal dose of
vorinostat to use in combination with standard chemotherapy alone (or in combination with
plus trastuzumab for HER2-positive disease), and to determine whether vorinostat enhances the
effectiveness of standard chemotherapy (+/- trastuzumab) in patients with locally advanced
breast cancer.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Albert Einstein College of Medicine Albert Einstein College of Medicine of Yeshiva University