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
Key eligibility criteria include:
- Newly diagnosed invasive breast cancer awaiting surgery or neoadjuvant (preoperative)
- 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.
Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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
Vered Stearns, M.D.
Sidney Kimmel Comprehensive Cancer Center
United States: Institutional Review Board
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|