Breast Cancer Clinical Trial
Official title:
A Randomized Phase II Trial of Two Doses of Raloxifene in Pre-Menopausal Women at High Risk For Developing Invasive Breast Cancer
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
development or recurrence of cancer. The use of raloxifene may be an effective way to
prevent breast cancer in premenopausal women.
PURPOSE: Phase II trial to study the effectiveness of raloxifene in preventing invasive
breast cancer in premenopausal women.
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.
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
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