S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: anastrozole; fulvestrant
Intervention description: Given orally; Given intramuscularly
Intervention MeSH terms: Fulvestrant; Anastrozole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 695.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage IV breast cancer; recurrent breast cancer

Summary:

      RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using
      drugs such as anastrozole and fulvestrant may fight breast cancer by blocking the use of
      estrogen. It is not yet known whether anastrozole is more effective with or without
      fulvestrant in treating breast cancer.

      PURPOSE: This randomized phase III trial is studying giving anastrozole together with
      fulvestrant to see how well it works compared to anastrozole alone as first-line therapy in
      treating postmenopausal women with metastatic breast cancer.
    

Eligibility criteria:

        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)