A Randomized Phase II Trial of Two Doses of Raloxifene in Pre-Menopausal Women at High Risk For Developing Invasive Breast Cancer

OBJECTIVES:

• 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 these participants.
• Determine the effect of raloxifene on the endometrium and ovaries in these participants.
• 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 participants.
• Determine the effect of raloxifene on bone mineral density in the spine and hip of these participants.

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 years.

Quality of life is assessed 1 week prior to study drug administration and at 6, 12, 24 and 36 months after study drug administration.