Breast Cancer Clinical Trial
Official title:
Pre-Surgical Trial of Letrozole in Post-Menopausal Patients With Operable Hormone-Sensitive Breast Cancer (Spore)
RATIONALE: Hormone therapy using letrozole may fight breast cancer by lowering the amount of
estrogen the body makes. Giving letrozole before surgery allows us to monitor the effects of
letrozole on the tumor on a molecular level and determine markers of response to treatment.
PURPOSE: This study will show us how well letrozole works in treating postmenopausal women
with stage I, II or III breast cancer that can be removed by surgery.
OBJECTIVES:
Primary To determine that in breast tumors that continue to exhibit high proliferation (i.e.,
Ki67) upon hormone deprivation (with letrozole), their gene expression and/or a mutational or
proteomic signatures will harbor molecules or 'pathways' that are biomarkers of resistance to
endocrine therapy or a cause of it.
The ultimate goal of these aims is to identify clinically-targetable pathways which can be
exploited to enhance responses and survival in patients with ER+ breast cancer.
OUTLINE: Patients receive oral letrozole once daily for 7-21 days in the absence of disease
progression or unacceptable toxicity. Within 24 hours after the last dose of letrozole,
patients undergo total mastectomy or segmental resection with lymph node evaluation.
Pre-treatment diagnostic breast tissue is obtained. Patients undergo treatment and then
undergo standard of care mastectomy or lumpectomy. Pre and post treatment tumor tissue
samples are analyzed for Ki67, P-ER, ER, progesterone receptor (PR), and caspase 3 by
immunohistochemistry; and RNA microarray.
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