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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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Emory University
Atlanta, Georgia, United States
Surgical Associates, Inc.
Tulsa, Oklahoma, United States
Allegheny Cancer Center
Pittsburgh, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center, One Hundred Oaks
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Start Date
March 1, 2008
Primary Completion Date
September 1, 2018
Completion Date
September 1, 2018
Last Updated
October 15, 2018
213
ACTUAL participants
letrozole
DRUG
Blood Collection
OTHER
biopsy/lumpectomy/mastectomy
PROCEDURE
Lead Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
NCT04704661
NCT05372640
Data Source & Attribution
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