NCT01194427

A Study of Vorinostat and Tamoxifen in Newly Diagnosed Breast Cancer

A Multi-Institutional Phase II Study Evaluating Surrogate Biomarkers of Response to Short Term Oral Vorinostat and Tamoxifen in Women With Newly Diagnosed Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is designed to look at the effects of the combination of vorinostat (Suberoylanilide Hydroxamic Acid or Zolinza) and tamoxifen on breast cancer tissue. The investigators will do this by comparing tissues from the original breast biopsy to tissues obtained after taking vorinostat and tamoxifen for 2 weeks.

Detailed description

Key eligibility criteria include: * Newly diagnosed invasive breast cancer awaiting surgery or neoadjuvant (preoperative) treatment * No use of hormone contraceptives or replacement therapy within 30 days prior to the diagnostic breast cancer biopsy (unless willing to have an additional biopsy prior to starting the study) * No prior or current use of any therapy to treat the current breast cancer.

Conditions

• Stage I Breast Cancer
• Stage II Breast Cancer
• Stage III Breast Cancer
• Invasive Breast Cancer

Interventions

Type	Name	Description
DRUG	Vorinostat and Tamoxifen	vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily for 14 days

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2010-09-03
• Last updated: 2013-05-17
• Results posted: 2013-05-17

Locations

1 site across 1 country: United States