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About
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether giving chemotherapy before hormone therapy is more effective than giving hormone therapy before chemotherapy in treating breast cancer.
PURPOSE: This randomized phase III trial is studying chemotherapy to see how well it works when given before or after hormone therapy as first-line therapy in treating postmenopausal women with metastatic or locally advanced breast cancer.
Full description
OBJECTIVES:
OUTLINE: This is an open-label, randomized, crossover, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
NOTE: *Patients may receive chemotherapy on a separate clinical chemotherapy trial but must first undergo randomization in this study.
Quality of life and pain are assessed at baseline and then periodically for 5 years.
After completion of study therapy, patients are followed periodically.
PROJECTED ACCRUAL: A total of 1,500 patients will be accrued for this study.
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Measurable or evaluable progressing metastases or local disease
No immediately life-threatening metastatic disease
No known HER2/neu positivity, as defined by either of the following:
No known cerebral or leptomeningeal metastases
Hormone receptor status:
PATIENT CHARACTERISTICS:
Female
Postmenopausal, as defined by any of the following:
ECOG performance status 0-2
No serious hypersensitivity to letrozole or other components of study drug
No other prior or concurrent malignancy except for basal cell carcinoma or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
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Data sourced from clinicaltrials.gov
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