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A Pilot Study Evaluating Surrogates of Response to Short Term Oral Suberoylanilide Hydroxamic Acid (SAHA) in Women With Newly Diagnosed Breast Cancer
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.
PRIMARY OBJECTIVE: I. Determine the safety and tolerability of vorinostat in women undergoing conventional surgery for newly diagnosed stage I-III breast cancer. OULINE: This is a multicenter, pilot study. Patients receive oral vorinostat twice daily on days -3 to 0. Approximately 2 hours after the final dose of vorinostat, patients undergo surgical resection of the tumor on day 0. After completion of study treatment, patients are followed for 30 days.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Start Date
October 1, 2005
Primary Completion Date
October 1, 2008
Completion Date
May 1, 2013
Last Updated
February 19, 2020
54
ACTUAL participants
vorinostat
DRUG
conventional surgery
OTHER
Lead Sponsor
National Cancer Institute (NCI)
NCT05673200
NCT04704661
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