Premenopausal women at increased risk for breast cancer based on a family history of disease will be eligible for this randomized trial to one of three arms: LY353881yHCl, tamoxifen or placebo for 6 months. The objectives of the study are 1) to determine the safety of the class of SERMs in premenopausal women by monitoring the effects on bone mineral density, the ovary, ovarian function, and lipids; 2) biomarkers of breast cancer will be developed by sampling the breasts of the high risk women and determining the biomarkers that are modulated by the agents compared with placebo; 3)serum biomarkers will be evaluated with IGF1 and IGFB3 levels pre and post treatment and ; 4) the feasibility of accrual of premenopausal women with a potential for a genetic predisposition to a chemoprevention study will be evaluated.
| Antonarakis, Emmanuel S; Heath, Elisabeth I; Walczak, Janet R et al. (2009) Phase II, randomized, placebo-controlled trial of neoadjuvant celecoxib in men with clinically localized prostate cancer: evaluation of drug-specific biomarkers. J Clin Oncol 27:4986-93 |
| Heath, Elisabeth I; DeWeese, Theodore L; Partin, Alan W et al. (2002) The design of a randomized, placebo-controlled trial of celecoxib in preprostatectomy men with clinically localized adenocarcinoma of the prostate. Clin Prostate Cancer 1:182-7 |
