A Randomized Phase II Trial of Two Doses of Raloxifene in Pre-Menopausal Women at High Risk For Developing Invasive Breast Cancer
23 Years
47 Years
Female
Breast Cancer
Trial Information
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.
Participants are followed for 1 year.
PROJECTED ACCRUAL: A total of 41 participants will be accrued for this study within 3 years.
Inclusion Criteria
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:
- Family with more than 2 breast cancer cases and one or more cases of
ovarian cancer diagnosed at any age
- Family with more than 3 breast cancer cases diagnosed before age 50
- Sister pairs with 2 breast cancers, 2 ovarian cancers, or 1 breast and 1
ovarian cancer diagnosed before age 50
- Premenopausal
- Menstrual cycle of 26-35 days
- No change in menstrual pattern within the past 6 months (no irregularities)
- FSH level less than 20 mIU/mL
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 23 to 47
Sex
- Female
Menopausal status
- Premenopausal
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- No history of bleeding disorder
Hepatic
- No history of cirrhosis of the liver
- SGOT/SGPT no greater than 3 times upper limit of normal (ULN)
Renal
- Creatinine no greater than 1.7 mg/dL
Cardiovascular
- No history of pulmonary embolism or deep venous thrombosis
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile participants must use effective non-hormonal contraception (e.g. barrier
methods, spermicides, or surgical methods) during and for 3 months after study
- No history of infertility with a suspected ovarian etiology or recurrent ovarian
cysts
- No allergy to raloxifene
- No dysfunctional uterine bleeding
- No menorrhagia
- No cervical dysplasia or significant uterine pathology requiring concurrent surgery
- No medical or psychiatric disorder that would preclude study participation
- Normal CA 125 levels
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- At least 6 months since prior steroid therapy (e.g., tamoxifen, estrogen, DHEA,
anabolic steroids, or oral contraceptives)
Radiotherapy
- See Disease Characteristics
Surgery
- See Disease Characteristics
- No prior hysterectomy
Type of Study:
Interventional
Study Design:
Primary Purpose: Prevention
Principal Investigator
Jennifer Eng-Wong, MD
Investigator Role:
Study Chair
Investigator Affiliation:
National Cancer Institute (NCI)
Authority:
United States: Federal Government
Study ID:
CDR0000066428
NCT ID:
NCT00019500
Start Date:
December 1998
Completion Date:
June 2005
Related Keywords:
- Breast Cancer
- breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Medicine Branch | Bethesda, Maryland 20892 |
