A Randomized Phase II Trial of Two Doses of Raloxifene in Pre-Menopausal Women at High Risk For Developing Invasive Breast Cancer
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:
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.
DISEASE CHARACTERISTICS:
At risk for developing invasive breast cancer by virtue of 1 of the following criteria:
Gail model risk equal to that of an average 60 year old woman as determined using the Gail risk assessment model
Lobular neoplasia
Atypical ductal hyperplasia with a positive family history of breast cancer
Ductal carcinoma in situ previously treated with mastectomy or lumpectomy and radiation
BRCA1 or BRCA2 mutation-positive genotyping
Family history consistent with hereditary cancer syndrome of increased breast cancer risk defined as 1 of the following:
Premenopausal
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery