drugset / Trial / NCT00262834

Vorinostat in Treating Women Who Are Undergoing Surgery For Newly Diagnosed Stage I -III Breast Cancer

NCT00262834 ↗

Phase 2 Completed 54 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

Summary

This phase II trial is studying how well vorinostat works in treating women who are undergoing surgery for newly diagnosed stage I, stage II, or stage III breast cancer. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat before surgery may shrink the tumor so that it can be removed.

Timeline

Start
2005-10
Primary completion
2008-10
Completion
2013-05

Outcome

Missed primary endpoint

registry analysis (unspecified test); Vorinostat vs Tissue Only; p = 0.42; Wilcoxon (Mann-Whitney) NCT00262834 ↗

registry analysis (unspecified test); Vorinostat vs Tissue Only; p = 0.50; Wilcoxon (Mann-Whitney) NCT00262834 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Vorinostat Small molecule — Oral