At a glance
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Phase I-II Trial of Vorinostat Plus Weekly Paclitaxel (+/- Trastuzumab) Followed by Doxorubicin-cyclophosphamide in Patients With Locally Advanced Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Vorinostat, Paclitaxel, and 4 other interventions for Breast Cancer. Completed, enrolled 55 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Vorinostat 200 or 300 mg PO BID on days 1-3 of each weekly paclitaxel dose
Paclitaxel 80 mg/m2 weekly for 12 weeks
Trastuzumab (if HER2-positive) 4 mg/kg, then 2 mg/kg weekly for 12 weeks including loading dose
Doxorubicin 60 mg/m2 every 2 weeks for 8 weeks
Cyclophosphamide 600 mg/m2 every 2 weeks for 8 weeks
Surgical excision of tumor from breast