A Randomized Phase II Trial of Two Doses of Raloxifene in Pre-Menopausal Women at High Risk For Developing Invasive Breast Cancer
- Determine the safety and tolerability of raloxifene in premenopausal women at high risk
of developing invasive breast cancer.
- Determine the effect of raloxifene on blood steroid hormone levels (luteinizing
hormone, estradiol, progesterone) and carotenoid levels during the menstrual cycle in
- Determine the effect of raloxifene on the endometrium and ovaries in these
- Determine the effect of raloxifene on biochemical markers of bone metabolism, lipid
profiles, and fibrinogen in these participants.
- Determine the effect of raloxifene on health-related quality of life of these
- Determine the effect of raloxifene on bone mineral density in the spine and hip of
OUTLINE: This is an open-label study.
Participants are medically evaluated, followed by an observation period of 1 to 2 menstrual
cycles. After the observation period, participants receive oral raloxifene once daily for 2
Quality of life is assessed 1 week prior to study drug administration and at 6, 12, 24 and
36 months after study drug administration.
Participants are followed for 1 year.
PROJECTED ACCRUAL: A total of 41 participants will be accrued for this study within 3 years.
Primary Purpose: Prevention
Jennifer Eng-Wong, MD
National Cancer Institute (NCI)
United States: Federal Government
|Medicine Branch||Bethesda, Maryland 20892|