Raloxifene in Preventing Breast Cancer in Premenopausal Women
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: raloxifene (Drug); evaluation of cancer risk factors (Procedure)
Phase: Phase 2
Status: Completed
Sponsored by: National Cancer Institute (NCI) Official(s) and/or principal investigator(s):
Jennifer Eng-Wong, MD, Study Chair, Affiliation: National Cancer Institute (NCI)
Summary
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.
Clinical Details
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 design: Prevention
Detailed description:
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.
Eligibility
Minimum age: 23 Years.
Maximum age: 47 Years.
Gender(s): Female.
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
Locations and Contacts
Medicine Branch, Bethesda, Maryland 20892, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: December 1998
Last updated: May 23, 2008
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