Status:
COMPLETED
Letrozole in Preventing Breast Cancer in Postmenopausal Women Who Are at Increased Risk for Breast Cancer Due to High Breast Density
Lead Sponsor:
NCIC Clinical Trials Group
Conditions:
Breast Cancer
Eligibility:
FEMALE
Up to 120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of letrozole may stop cancer from forming or coming back in postmenopausal women wh...
Detailed Description
OBJECTIVES: Primary * Determine the proportion of postmenopausal women who are at increased risk for the development or recurrence of breast cancer, based on high breast density (≥ grade 4), who ach...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- At increased risk for the development or recurrence of breast cancer, as defined by 1 of the following:
- Baseline mammogram indicating mammographic density occupying ≥ 25% (grade 4/6, 5/6, or 6/6) of the breast tissue
- No suspicion of breast cancer, unless subsequently ruled out
- Prior ductal carcinoma in situ (DCIS)
- Untreated disease OR \> 6 months since completion of adjuvant endocrine therapy
- Receptor status of lesion is not required
- Prior invasive breast cancer
- Breast cancer must have been surgically removed at time of original diagnosis with no evidence of metastases
- No clinical evidence of breast cancer
- Acceptable quality dual-energy x-ray absorptiometry (DEXA) of the L2-L4 postero-anterior (PA) spine and hip performed within past 6 months
- Bone mass density T-score of either PA spine or hip must be ≥ 2.0 SD below the mean peak bone mass in young normal woman
- Stable chronic leukemia allowed
- Hormone receptor status:
- Hormone receptor-negative, -positive, or -equivocal tumor
- PATIENT CHARACTERISTICS:
- Age
- Postmenopausal
- Sex
- Female
- Menopausal status
- Postmenopausal, as defined by 1 of the following:
- Over 55 years of age with spontaneous cessation of menses for ≥ 1 year
- 55 years of age and under with spontaneous cessation of menses for ≤ 1 year, but amenorrheic (e.g., spontaneous or secondary to hysterectomy) AND follicle-stimulating hormone level \> 34.4 IU/L
- Bilateral oophorectomy
- Performance status
- Not specified
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Not specified
- Renal
- Not specified
- Cardiovascular
- No recent unstable myocardial infarction
- No prior stroke
- No high blood pressure
- No other uncontrolled cardiovascular disease
- Other
- Other prior malignancies without metastatic disease allowed
- Willing and able to complete quality of life questionnaires in either English or French
- No uncontrolled metabolic or endocrine disease
- No malabsorption syndrome
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent immunotherapy
- Chemotherapy
- No concurrent chemotherapy
- Endocrine therapy
- See Disease Characteristics
- At least 3 months since prior and no concurrent hormone replacement therapy or raloxifene
- At least 6 months since prior tamoxifen
- No concurrent steroid therapy
- No concurrent selective estrogen-receptor modulators
- No other concurrent endocrine or hormonal therapy
- Radiotherapy
- Not specified
- Surgery
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
December 5 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2009
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00238316
Start Date
December 5 2000
End Date
February 10 2009
Last Update
April 2 2020
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
2
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115-6084
3
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
4
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7