Status and phase
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About
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant, anastrozole, or exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. It is not yet known whether giving fulvestrant together with anastrozole is more effective than giving fulvestrant together with a placebo or exemestane alone in treating breast cancer.
PURPOSE: This randomized phase III trial is studying fulvestrant and anastrozole to see how well they work compared to fulvestrant and a placebo or exemestane alone in treating postmenopausal women with locally advanced or metastatic breast cancer.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, partially double-blind and placebo-controlled, multicenter study. Patients are stratified according to the setting in which prior nonsteroidal aromatase-inhibitor therapy was given (adjuvant therapy vs first-line therapy) and participating center. Patients are randomized to 1 of 3 treatment arms.
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 750 patients (250 per treatment arm) will be accrued for this study.
Enrollment
Sex
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the breast
Metastatic disease must be measurable or evaluable
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
No rapidly progressive visceral disease (i.e., lymphangitis carcinomatosa or diffuse hepatic involvement)
Hormone receptor status:
PATIENT CHARACTERISTICS:
Sex
Menopausal status
Postmenopausal, as defined by 1 of the following criteria:
Performance status
Life expectancy
Hematopoietic
Neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 10 g/dL
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Endocrine therapy
Other
More than 4 weeks since prior investigational drugs
Concurrent bisphosphonates for bone metastases allowed provided bisphosphonate therapy has been established for ≥ 6 months
No concurrent anticoagulant therapy
No concurrent unlicensed noncancer investigational agents
Primary purpose
Allocation
Interventional model
Masking
698 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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