Letrozole in Preventing Breast Cancer in Postmenopausal Women
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Letrozole; Placebo
Intervention MeSH terms: Letrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 49.0
Sex: Female
Minimum age: 35 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: breast cancer; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer; breast cancer in situ; ductal breast carcinoma in situ

Summary:

      RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
      development or recurrence of cancer. Letrozole may be effective in preventing the development
      or recurrence of breast cancer in postmenopausal women who are at increased risk of
      developing breast cancer because of elevated estradiol levels.

      PURPOSE: This randomized phase II trial is studying how well letrozole works in preventing
      breast cancer in postmenopausal women with elevated estradiol levels.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  At increased risk for the development or recurrence of breast cancer, defined as an
             estradiol level ≥ 9 pg/mL

          -  No evidence of suspicious or malignant disease, based on the following examinations:

               -  Clinical bilateral breast examination within the past 6 months

               -  Bilateral* mammogram within 3 months before randomization OR within 30 days after
                  randomization

               -  Pelvic exam normal within the past 5 years

               -  General physical exam within the past 6 months NOTE: *Unilateral mammogram of the
                  uninvolved breast for patients with prior invasive breast cancer or ductal
                  carcinoma in situ (DCIS)

          -  Bone density scan within 2 standard deviations from normal within the past 30 days

               -  Bone density scan ≥ 2 standard deviations below normal allowed if approved by the
                  study physician

          -  At least 1 breast that has not been previously treated with radiotherapy or surgery
             (for patients with prior invasive breast cancer or DCIS)

          -  Hormone receptor status:

               -  Not specified

        PATIENT CHARACTERISTICS:

        Age

          -  35 and over

        Sex

          -  Female

        Menopausal status

          -  Postmenopausal, defined by any of the following criteria:

               -  At least 12 months without spontaneous menstrual bleeding

               -  Prior hysterectomy and bilateral salpingo-oophorectomy

               -  ≥ 55 years of age with a prior hysterectomy with or without oophorectomy

               -  < 55 years of age with a prior hysterectomy without oophorectomy OR the status of
                  the ovaries is unknown AND follicle-stimulating hormone (FSH) level is in the
                  postmenopausal range

        Performance status

          -  Normal activity must not be restricted for a significant portion of the day

        Life expectancy

          -  At least 10 years

        Hematopoietic

          -  Complete blood count with differential normal

               -  Prior benign neutropenia allowed provided the granulocyte count is ≥ 1,500/mm^3

        Hepatic

          -  Bilirubin normal

          -  Alkaline phosphatase normal

          -  SGOT and SGPT normal

        Renal

          -  Creatinine normal

        Cardiovascular

          -  No uncontrolled cardiovascular disease

        Other

          -  Not pregnant

          -  No other malignancy within the past 5 years except basal cell or squamous cell skin
             cancer or carcinoma in situ of the cervix

          -  No osteoporosis

          -  No hyperlipidemia

          -  No mental health status resulting in cognitive or emotional impairment that would
             preclude study participation

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  Not specified

        Endocrine therapy

          -  More than 30 days since prior AND no concurrent use of any of the following hormonal
             agents:

               -  Estrogen or progesterone replacement therapy

               -  Oral contraceptives

               -  Raloxifene or other plasma estrogen receptor modulators (SERMs)

               -  Androgens (e.g., danazol)

               -  Luteinizing hormone-releasing hormone (LHRH) analogs (e.g., goserelin or
                  leuprolide)

               -  Prolactin inhibitors (e.g., bromocriptine)

               -  Antiandrogens (e.g., cyproterone)

          -  More than 60 days since prior AND no concurrent tamoxifen

          -  No prior aromatase inhibitors (for patients with prior invasive breast cancer or DCIS)

          -  No concurrent phytoestrogenic dietary supplements (e.g., soy, ginseng, or other
             natural products)

               -  Dietary soy allowed

        Radiotherapy

          -  See Disease Characteristics

        Surgery

          -  See Disease Characteristics

          -  No prior bilateral mastectomy

        Other

          -  More than 60 days since prior treatment for invasive breast cancer or DCIS

          -  More than 30 days since prior bisphosphonates or calcitonin

          -  No prior or concurrent participation on a treatment study for invasive breast cancer
             or DCIS

          -  No concurrent participation in any other cancer prevention study or osteoporosis
             prevention study involving pharmacologic agents

          -  No concurrent calcitonin

          -  No concurrent bisphosphonate therapy

          -  Concurrent cholecalciferol (vitamin D) and calcium to augment bone mineral density
             allowed