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
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.
Status | Terminated |
Enrollment | 2 |
Est. completion date | November 2011 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center | Merck Sharp & Dohme Corp. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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