A Window Trial of Vorinostat in Patients With Ductal Carcinoma in Situ (DCIS) of the Breast
- To evaluate the in vivo molecular and biological effects of vorinostat by analyzing
changes in proliferation and apoptosis, histone acetylation, and HDAC protein
expression in women with ductal carcinoma in situ of the breast.
OUTLINE: Patients receive oral vorinostat twice a day for 3 days in the absence of
unacceptable toxicity. Patients then undergo lumpectomy or mastectomy 2 hours after the last
dose of vorinostat.
Blood and tissue samples are collected at baseline and during surgery for biomarker
laboratory studies. Samples are analyzed by immunohistochemistry for Ki-67, HDAC1 and HDAC6
protein expression, and histone H4 and α-tubulin acetylation.
After completion of study therapy, patients are followed for 1 month and then every 6 months
for 5 years.
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Reduction in Ki-67 compared to baseline Ki-67
3 days prior to surgery
Laura Esserman, MD, MBA
University of California, San Francisco
United States: Food and Drug Administration
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|