Anastrozole or Tamoxifen in Treating Postmenopausal Women With Ductal Carcinoma in Situ Who Are Undergoing Lumpectomy and Radiation Therapy

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed ductal carcinoma in situ (DCIS) of the breast
• * Mixed DCIS and lobular carcinoma in situ (LCIS) allowed
• Must have undergone lumpectomy
• * Margins must be histologically free of disease
• * Re-excision to obtain tumor-free margins allowed
• * No more than 84 days since prior lumpectomy or re-excision
• More than 1 area of DCIS allowed provided all disease is removed with tumor-free margins
• * Masses or clusters of calcification that are clinically or mammographically suspicious must be biopsied
• No prior invasive breast cancer or DCIS
• * Patients with a history of LCIS are eligible
• No prior or concurrent invasive (including microinvasive) breast cancer
• * DCIS "suspicious" for microinvasion allowed
• No bilateral malignancy
• * No mass or mammographic abnormality suspicious for malignancy in the opposite breast unless not malignant as proven by biopsy
• No Paget's disease of the nipple
• No positive ipsilateral axillary or intramammary nodes
• * No palpable nodes in the ipsilateral or contralateral axilla or palpable supraclavicular or infraclavicular nodes unless not involved with tumor as proven by biopsy
• Hormone receptor status:
• * Estrogen- or progesterone-receptor positive as determined by immunohistochemistry
• * Borderline results are considered positive
• PATIENT CHARACTERISTICS:
• Age
• See Menopausal status
• Sex:
• Female
• Menopausal status:
• Postmenopausal as defined by at least 1 of the following:
• * Prior documented bilateral oophorectomy
• * At least 12 months without spontaneous bleeding
• * Age 55 or over with prior hysterectomy without oophorectomy
• * Age 54 or under with prior hysterectomy without oophorectomy with a documented follicle-stimulating hormone level in the postmenopausal range
• Performance status
• Zubrod 0-2
• Life expectancy
• At least 10 years (excluding diagnosis of breast cancer)
• Hematopoietic
• WBC normal
• Hepatic
• AST normal
• Bilirubin normal
• Alkaline phosphatase normal
• No hepatic disease that would preclude administration of study drugs
• Renal
• Creatinine normal
• No renal disease that would preclude administration of study drugs
• Cardiovascular
• No prior documented cerebral vascular accident or transient ischemic attack
• No prior deep vein thrombosis
• No cardiovascular disease that would preclude administration of study drugs
• No uncontrolled hypertension (i.e., systolic blood pressure at least 180 mm Hg or diastolic blood pressure at least 110 mm Hg based on the average of 2 or more readings at each of 2 or more visits after initial screening)
• No uncontrolled atrial fibrillation
• Pulmonary
• No pulmonary embolus
• Other
• Not pregnant or nursing
• Patients with a history of non-breast malignancies are eligible provided they have been disease-free for ≥ 5 years and are deemed by their physician to be at low risk for recurrence
• No other malignancy within the past 5 years except treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the colon, or melanoma in situ
• No psychiatric or addictive disorders that would preclude informed consent
• No uncontrolled diabetes, defined as hemoglobin A1C greater than 9% (fasting glucose 200 mg/dL)
• No nonmalignant systemic disease that would preclude administration of study drugs
• PRIOR CONCURRENT THERAPY:
• Endocrine therapy
• No prior or concurrent aromatase inhibitors (e.g., exemestane or letrozole) or tamoxifen
• No concurrent raloxifene or other selective estrogen receptor modulators
• No concurrent sex hormone therapy (e.g., estrogen or progesterone replacement therapy, oral contraceptives, androgens, luteinizing hormone releasing hormone analogs, prolactin inhibitors, or antiandrogens)
• * Low-dose estrogen vaginal creams or Estring allowed
• Radiotherapy
• Radiotherapy for this cancer initiated before study is allowed
• Surgery
• See Disease Characteristics
• No prior or concurrent mastectomy for DCIS
• Prior sentinel node biopsy or axillary node dissection allowed provided nodes are pathologically negative
• Other
• No concurrent warfarin
• No other systemic therapy for this cancer initiated before study
• No other concurrent anticancer therapy unless permitted by the protocol investigator
• No concurrent participation in another clinical trial of therapy for DCIS
• * Concurrent participation in protocol NSABP-B-39 allowed