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

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)