A Randomized Trial Of Raloxifene Plus Zoladex For Prevention Of Breast Cancer
30 Years
45 Years
Female
Breast Cancer
Trial Information
A Randomized Trial Of Raloxifene Plus Zoladex For Prevention Of Breast Cancer
OBJECTIVES:
- Compare the feasibility of raloxifene and goserelin versus no medical intervention in
women at high genetic risk for developing breast cancer.
- Compare the incidence of adverse effects in patients treated with these regimens.
- Compare the effect of these regimens on bone density, biochemical markers of bone
turnover, and lipid profiles in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive goserelin subcutaneously once every month and oral raloxifene
daily for 6-12 months.
- Arm II: Patients are screened for breast cancer every 6 months. In both arms, patients
undergo annual mammograms.
Quality of life is assessed at baseline and at 1, 3, 6, and 12 months.
Patients are followed for 5 years.
PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this
study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- High genetic risk of developing breast cancer defined as one or more of the
following:
- BRCA1 or BRCA2 germ-line mutation
- First-degree relative of known BRCA1 or BRCA2 mutation carrier
- Family with 4 or more relatives diagnosed with female or male breast cancer or
ovarian cancer before the age of 60
- Two first-degree relatives diagnosed with breast cancer before the age of 40
- p53 germ-line mutation (classical Li-Fraumeni syndrome (LFS) only)
- First-degree relative of a carrier in a family with classical LFS
- Risk equivalent to any of the above confirmed by clinical geneticist
- No evidence of breast cancer by mammography
- Suspicious lesions must be confirmed as non-malignant
- No prior breast cancer
- No prior prophylactic mastectomy
- No plan for alternative prevention measures within the next 12 months
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 30 to 45
Sex:
- Female
Menopausal status:
- Premenopausal (follicle-stimulating hormone in premenopausal range if not
menstruating)
Performance status:
- Not specified
Life expectancy:
- More than 10 years (excluding breast cancer risk)
Hematopoietic:
- Not specified
Hepatic:
- Adequate liver function
Renal:
- Adequate renal function
Cardiovascular:
- No prior deep vein thrombosis
Pulmonary:
- No prior pulmonary embolism
Other:
- Not pregnant
- Fertile patients must use effective nonhormonal contraception
- No psychological disorder that would preclude study compliance
- No prior malignancy within the past 5 years except curatively treated nonmelanoma
skin cancer or cervical cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- No concurrent hormonal therapy (e.g., oral contraception or hormone replacement
therapy)
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
Other:
- At least 30 days or 5 half-lives since prior investigational drugs
- No concurrent anticoagulants
Type of Study:
Interventional
Study Design:
Primary Purpose: Prevention
Principal Investigator
Anthony Howell, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Christie Hospital NHS Foundation Trust
Authority:
United States: Federal Government
Study ID:
NCRI-IBIS-RAZOR
NCT ID:
NCT00031850
Start Date:
March 2000
Completion Date:
May 2007
Related Keywords:
- Breast Cancer
- breast cancer
- Breast Neoplasms
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