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

Inclusion Criteria

• •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