Study of Faslodex +/- Concomitant Arimidex v Exemestane Following Progression on Non-steroidal Aromatase Inhibitors

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed adenocarcinoma of the breast
• * Locally advanced or metastatic disease
• Metastatic disease must be measurable or evaluable
• * Patients with bone only metastases are eligible provided there is an evaluable site of bone metastasis that can be followed by x-ray, MRI, or CT scan
• Relapsed or progressed during prior treatment with single-agent nonsteroidal aromatase inhibitor (NSAI)\*, meeting either of the following criteria:
• * NSAI given as adjuvant therapy that lasted ≥ 12 months
• * Achieved an objective complete response, partial response, or stable disease that lasted ≥ 6 months after prior first-line therapy with NSAI for locally advanced or metastatic disease
• * Chemotherapy as part of the first-line therapy given before initiation of NSAI allowed NOTE: \*Patients are required to continue to take NSAI until beginning of study treatment.
• No rapidly progressive visceral disease (i.e., lymphangitis carcinomatosa or diffuse hepatic involvement)
• Hormone receptor status:
• * Estrogen receptor (ER) and/or progesterone receptor positive tumor
• * No ER-unknown disease
• PATIENT CHARACTERISTICS:
• Sex
• Female
• Menopausal status
• Postmenopausal, as defined by 1 of the following criteria:
• * Age 60 and over
• * Age 45 to 59 AND ≥ 12 months since last menstrual period with no prior hysterectomy
• * Any age with prior bilateral oophorectomy
• Performance status
• WHO 0-2
• Life expectancy
• More than 3 months
• Hematopoietic
• Neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• * No thrombocytopenia
• Hemoglobin ≥ 10 g/dL
• Hepatic
• AST and ALT ≤ 2.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 5 times ULN (unless due to bone metastases)
• No liver disease
• Renal
• Creatinine \< 1.97 mg/dL
• Other
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• PRIOR CONCURRENT THERAPY:
• Chemotherapy
• See Disease Characteristics
• Prior neoadjuvant or adjuvant chemotherapy allowed
• Endocrine therapy
• See Disease Characteristics
• Prior tamoxifen as neoadjuvant or adjuvant therapy allowed
• No systemic corticosteroids that lasted \> 15 days within the past 4 weeks
• Other
• More than 4 weeks since prior investigational drugs
• Concurrent bisphosphonates for bone metastases allowed provided bisphosphonate therapy has been established for ≥ 6 months
• * Concurrent initiation of bisphosphonate allowed provided patient has soft tissue or visceral metastases as the measurable or evaluable target lesion
• No concurrent anticoagulant therapy
• No concurrent unlicensed noncancer investigational agents