Trial for Locally Advanced Breast Cancer Using Vorinostat Plus Chemotherapy
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.
Timeline
- Start
- 2007-12
- Primary completion
- 2014-05
- Completion
- 2014-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vorinostat | Small molecule | 200 mg | Oral |
| Subject | Vorinostat | Small molecule | 300 mg | Oral |
| Background | Cyclophosphamide | Other / unclassified | 600 mg/m2 | — |
| Background | Doxorubicin | Other / unclassified | 60 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Background | Trastuzumab | Monoclonal antibody | 2 mg/kg | Intravenous |