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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.
Active, not recruiting
Ages:18 and older
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)
Sponsor: Southwest Oncology Group
Phase: Phase 3
Trial ID: NCT00075764
Not Accepting Healthy Volunteers