(Arzoxifene) in Breast Hyperplasia
Principle Investigator: Carol Fabian, MD, University of Kansas Medical Center
Contributing Institutions: Creighton University, Omaha, NE, Henry T. Lynch, MD, US Oncology, Inc., Dallas, TX, Joyce A. O’Shaughnessy, MD
Creighton University’s Study Coordinator:
OBJECTIVES:
To evaluate the potential chemopreventive efficacy of oral Arzoxifene in monitoring the cytologic patterns of hyperplasia found in breast tissue of women at high risk for breast cancer.
To determine if Arzoxifene has an effect on cytologic and biomarker patterns as a function of BRCA1/2 genetic status or menopausal status.
To evaluate the side effects of Arzoxifene on a healthy high risk population which include pre-, post-, and per-menopausal women.
To compare 6 months administration of Arzoxifene to 12 months administration of Arzoxifene.
ELIGIBILITY CRITERIA:
A woman must meet the following criteria to be eligible for the Arzoxifene study:
Has at least one unaffected breast.
Is part of a hereditary breast/ovarian cancer family.
Is not currently on or have not in the last year been on Tamoxifen, Raloxifene, or Coumadin.
Has not had chemotherapy in the last 12 months.
Has not had radiation in the last 2-3 months.
Has not had a change in hormone status (oophorectomy or started on hormone replacement therapy) in the last 6 months.
Has not had blood clots in the last 10 years, (unless is was due to trauma or pregnancy).
Does not have saline or silicone implants.
If you are interested in learning more about this study, please contact us at 1-800-648-8133 Ext. 2312.
