S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed breast cancer meeting 1 of the following criteria:
• * Metastatic disease (M1)
• * Multiple sites of new disease that is clinically obvious metastatic disease (e.g., multiple sites of new osseous disease)
• Measurable or nonmeasurable disease
• No known brain or CNS metastases
• Hormone receptor status:
• * Estrogen-receptor positive\* AND/OR
• * Progesterone-receptor positive\* NOTE: \*Positivity defined as estrogen binding of \> 10 fmol/mg cytosol protein by ligand binding assay or positive by immunohistochemistry
• PATIENT CHARACTERISTICS:
• Age
• Not specified
• Sex
• Female
• Menopausal status
• Postmenopausal, as defined by 1 of the following:
• * Prior bilateral oophorectomy
• * More than 12 months since last menstrual period with no prior hysterectomy
• * At least 55 years of age with prior hysterectomy
• * Under 55 years of age with a prior hysterectomy without oophorectomy and with estradiol and follicle-stimulating hormone levels consistent with menopause
• Performance status
• Zubrod 0-2
• Life expectancy
• Not specified
• Hematopoietic
• No bleeding diathesis (e.g., disseminated intravascular coagulation or clotting factor deficiency)
• Hepatic
• INR ≤ 1.6
• Renal
• Not specified
• Other
• HIV negative
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• No prior immunotherapy for recurrent or metastatic disease
• Chemotherapy
• No prior chemotherapy for recurrent or metastatic disease
• More than 12 months since prior adjuvant or neoadjuvant chemotherapy
• No concurrent chemotherapy for malignancy
• Endocrine therapy
• Prior adjuvant hormonal therapy allowed
• At least 12 months since prior adjuvant luteinizing hormone-releasing hormone (LHRH) analogues
• * Menstrual periods must not have resumed since LHRH therapy
• More than 12 months since prior adjuvant or neoadjuvant aromatase inhibitors (e.g., anastrozole, letrozole, or exemestane)
• More than 12 months since prior fulvestrant
• No prior hormonal therapy for recurrent or metastatic disease
• No other concurrent hormonal therapy for malignancy
• No concurrent hormone replacement therapy
• Radiotherapy
• Not specified
• Surgery
• Not specified
• Other
• No long-term anticoagulant therapy (except antiplatelet therapy)