Raloxifene and Goserelin in Preventing Breast Cancer in Women With a Family History of Breast Cancer
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: goserelin (Drug); raloxifene (Drug)
Phase: N/A
Status: Completed
Sponsored by: Institute of Cancer Research, United Kingdom Official(s) and/or principal investigator(s):
Anthony Howell, MD, Study Chair, Affiliation: Christie Hospital
Summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
development or recurrence of cancer. The use of raloxifene and goserelin may be effective in
preventing breast cancer.
PURPOSE: Randomized pilot study to study the effectiveness of combining raloxifene and
goserelin in preventing breast cancer in women who have a family history of breast cancer.
Clinical Details
Official title: A Randomized Trial Of Raloxifene Plus Zoladex For Prevention Of Breast Cancer
Study design: Prevention
Detailed description:
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.
Eligibility
Minimum age: 30 Years.
Maximum age: 45 Years.
Gender(s): Female.
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
Locations and Contacts
Christie Hospital NHS Trust, Manchester, England M20 4BX, United Kingdom
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: March 2000
Last updated: May 23, 2008
|
