A Study of Vorinostat and Tamoxifen in Newly Diagnosed Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer, Invasive Breast Cancer

Intervention / Treatment
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* Drug: Vorinostat and Tamoxifen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage I-III invasive breast cancer Awaiting surgery or neoadjuvant treatment ECOG performance status 0, 1 or 2 Adequate organ function Prior use of hormone contraception or replacement therapy must have been discontinued at least 30 days prior to diagnostic biopsy (unless participant is willing to undergo an additional biopsy for the study) Exclusion Criteria: Prior or current treatment of any kind for the current breast cancer Current use of any other investigational drugs Uncontrolled or active infection, congestive heart failure, cardiac arrythmia, or psychiatric illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vorinostat and Tamoxifen<br>Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery. | Drug: Vorinostat and Tamoxifen<br>* vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily for 14 days<br>* Other names: Zolinza;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Markers of Proliferation Prior to and After Study Drug Administration | To determine the percentage change in proliferation index Ki-67 in both ER-positive and ER-negative tumors between baseline and post-treatment biopsy following 14 days of vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily in women with primary breast cancer awaiting definitive surgery. | Baseline and 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoperative, Neoadjuvant