Breast Cancer Clinical Trial
Official title:
A Window Trial of Vorinostat in Patients With Ductal Carcinoma in Situ (DCIS) of the Breast
RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth.
PURPOSE: This clinical trial is studying how well vorinostat works in treating women with
ductal carcinoma in situ of the breast.
OBJECTIVES:
- 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.
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