Vorinostat in Treating Women With Ductal Carcinoma in Situ of the Breast

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Drug: vorinostat; Genetic: protein expression analysis; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Procedure: neoadjuvant therapy; Procedure: therapeutic conventional surgery

• Registration Number: NCT00788112
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2008-11-07
• Study First Submitted QC: 2008-11-07
• Study First Posted: 2008-11-10
• Study Start: 2009-07
• Primary Completion: 2011-11-03
• Study Completion: 2015-08-11
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-04
• Last Update Posted: 2017-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vorinostat	vorinostat	-
Vorinostat	protein expression analysis	-
Vorinostat	immunohistochemistry staining method	-
Vorinostat	laboratory biomarker analysis	-
Vorinostat	neoadjuvant therapy	-
Vorinostat	therapeutic conventional surgery	-

Primary Outcome Measures

Name	Time	Method
Reduction in Ki-67 compared to baseline Ki-67	3 days prior to surgery

Secondary Outcome Measures

Name	Time	Method
Changes in HDAC1 and HDAC6 expression and histone H4 and α-tubulin acetylation in breast tissue and serum samples	3 days prior to surgery

Trial Locations

Locations (1)

UCSF Helen Diller Family Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States