Raloxifene in Preventing Breast Cancer in Premenopausal Women
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.
|Breast Cancer||Drug: raloxifene Procedure: evaluation of cancer risk factors||Phase 2|
|Study Design:||Primary Purpose: Prevention|
|Official Title:||A Randomized Phase II Trial of Two Doses of Raloxifene in Pre-Menopausal Women at High Risk For Developing Invasive Breast Cancer|
|Study Start Date:||December 1998|
|Study Completion Date:||June 2005|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00019500
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Jennifer Eng-Wong, MD||National Cancer Institute (NCI)|