a study on Breast Cancer
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.
Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior adjuvant tamoxifen therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed for up to 4 years.
PROJECTED ACCRUAL: A total of 690 patients (345 per treatment arm) will be accrued for this study within 3 years.
Breast Cancer stage IV breast cancer recurrent breast cancer Fulvestrant Anastrozole Estradiol
For females ages 18 years and up
Progesterone-receptor positive* NOTE: *Positivity defined as estrogen binding of
10 fmol/mg cytosol protein by ligand binding assay or positive by immunohistochemistry
Under 55 years of age with a prior hysterectomy without oophorectomy and with estradiol and follicle-stimulating hormone levels consistent with menopause
No bleeding diathesis (e.g., disseminated intravascular coagulation or clotting factor deficiency)
INR ≤ 1.6
PRIOR CONCURRENT THERAPY:
No prior immunotherapy for recurrent or metastatic disease
No concurrent chemotherapy for malignancy
No concurrent hormone replacement therapy
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