NCT00651976

Letrozole in Treating Postmenopausal Women With Stage I, II or III Breast Cancer That Can Be Removed by Surgery

Pre-Surgical Trial of Letrozole in Post-Menopausal Patients With Operable Hormone-Sensitive Breast Cancer (Spore)

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	letrozole	Take by mouth at a dose of 2.5 mg on days 7-21
OTHER	Blood Collection	Blood used for gene expression analysis and reverse transcriptase-polymerase chain reaction
PROCEDURE	biopsy/lumpectomy/mastectomy	Tissue collection,Surgery to remove tumor, Tumor tissues used for laboratory biomarker analysis

Timeline

• Start date: 2008-03-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2008-04-03
• Last updated: 2018-10-15

Locations

5 sites across 1 country: United States