Letrozole in Preventing Breast Cancer in Postmenopausal Women Who Are at Increased Risk for Breast Cancer Due to High Breast Density

• Status: Completed
• Trial end date: 2009-02-10
• Target enrollment: 0
• Participant gender: Female

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 who are at increased risk for breast cancer due to high breast density.

PURPOSE: This randomized phase II trial is studying how well letrozole works in preventing breast cancer in postmenopausal women who are at increased risk for breast cancer due to high breast density.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Treatments: Letrozole

Criteria

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