Vorinostat in Treating Women With Ductal Carcinoma in Situ of the Breast
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|ClinicalTrials.gov Identifier: NCT00788112|
Recruitment Status : Completed
First Posted : November 10, 2008
Last Update Posted : August 7, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: vorinostat Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Window Trial of Vorinostat in Patients With Ductal Carcinoma in Situ (DCIS) of the Breast|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||November 3, 2011|
|Actual Study Completion Date :||August 11, 2015|
|Experimental: Vorinostat||Drug: vorinostat Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery|
- Reduction in Ki-67 compared to baseline Ki-67 [ Time Frame: 3 days prior to surgery ]
- Changes in HDAC1 and HDAC6 expression and histone H4 and α-tubulin acetylation in breast tissue and serum samples [ Time Frame: 3 days prior to surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00788112
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Laura Esserman, MD, MBA||University of California, San Francisco|