Statement: A 55 year old postmenopausal patient with sarcoidosis would be excluded from the primary trial due to her age.
Primary_evidence: DISEASE CHARACTERISTICS:   Confirmed diagnosis of prior operable, noninflammatory breast cancer meeting the following criteria:   Steroid hormone receptor-positive tumors (estrogen receptor and/or progesterone receptor), determined by immunohistochemistry, after primary surgery and before commencement of prior endocrine therapy   Prior local treatment including surgery with or without radiotherapy for primary breast cancer with no known clinical residual loco-regional disease   Following primary surgery, eligible patients must have had evidence of lymph node involvement either in the axillary or internal mammary nodes, but not supraclavicular nodes   Clinically disease-free   Must have completed 4-6 years of prior adjuvant selective estrogen receptor modulators (SERMs), aromatase inhibitors (AIs), or a sequential combination of both   When calculating 4-6 years, neoadjuvant endocrine therapy should not be included   No evidence of recurrent disease or distant metastatic disease   No prior bilateral breast cancer   PATIENT CHARACTERISTICS:   Female   Must be postmenopausal by any of the following criteria:   Patients of any age who have had a bilateral oophorectomy (including radiation castration AND amenorrheic for > 3 months)   Patients 56 years old or older with any evidence of ovarian function must have biochemical evidence of definite postmenopausal status (defined as estradiol, luteinizing hormone [LH], and follicle-stimulating hormone [FSH] in the postmenopausal range)   Patients 55 years old or younger must have biochemical evidence of definite postmenopausal status (defined as estradiol, LH, and FSH in the postmenopausal range)   Patients who have received prior luteinizing-hormone releasing-hormone (LHRH) analogues within the last year are eligible if they have definite evidence of postmenopausal status as defined above   Clinically adequate hepatic function   No bone fracture due to osteoporosis at any time during the 4-6 years of prior therapy   No prior or current malignancy except adequately treated basal cell or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, or contra- or ipsilateral in situ breast carcinoma   No other nonmalignant systemic diseases (cardiovascular, renal, lung, etc.) that would prevent prolonged follow-up   No psychiatric, addictive, or any other disorder that compromises compliance with protocol requirements   PRIOR CONCURRENT THERAPY:   See Disease Characteristics   More than 12 months since prior and no other concurrent endocrine SERM/AI therapy   Any type of prior adjuvant therapy allowed including, but not limited to, any of the following:   Neoadjuvant chemotherapy   Neoadjuvant endocrine therapy   Adjuvant chemotherapy   Trastuzumab (Herceptin®)   Ovarian ablation   Gonadotropin releasing hormone analogues   Lapatinib ditosylate   No concurrent hormone-replacement therapy, bisphosphonates (except for treatment of bone loss), or any other investigational agent