A Study of Vorinostat and Tamoxifen in Newly Diagnosed Breast Cancer

Stage II Breast Cancer Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

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

• NCT number: NCT01194427
• Study type: Interventional
• Source: Sidney Kimmel Comprehensive Cancer Center
• Status: Terminated
• Phase: Phase 2
• Start date: March 2011
• Completion date: November 2011