Letrozole in Treating Postmenopausal Women With Stage I, II or III Breast Cancer That Can Be Removed by Surgery
|ClinicalTrials.gov Identifier: NCT00651976|
Recruitment Status : Suspended
First Posted : April 3, 2008
Last Update Posted : July 19, 2017
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Drug: letrozole Other: Blood Collection Procedure: biopsy/lumpectomy/mastectomy|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pre-Surgical Trial of Letrozole in Post-Menopausal Patients With Operable Hormone-Sensitive Breast Cancer (Spore)|
|Study Start Date :||March 2008|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||September 2019|
Take by mouth at a dose of 2.5 mg on days 7-21Other: Blood Collection
Blood used for gene expression analysis and reverse transcriptase-polymerase chain reactionProcedure: biopsy/lumpectomy/mastectomy
Tissue collection,Surgery to remove tumor, Tumor tissues used for laboratory biomarker analysis
- Ki67 index measured in hormone receptor-positive breast cancers compared to those that are hormone receptor-negative [ Time Frame: day 7 to day 21 ]Ki67 index is measured by counting the percentage of cells staining for Ki67 in a section of breast tissue. The number of stained cells will be compared in tissue that is hormone receptor-positive tissue to tissue that is hormone receptor negative.
- In situ apoptotic effect of letrozole [ Time Frame: day 7 to day 21 ]Measured by level of capase-3 in post-treatment breast tissue.
- Identification of a recurrence risk biomarker profile using RNA microarray [ Time Frame: day 7 to day 21 ]RNA will be extracted from pre- and post-treatment breast tissue and will be compared with the Ki67 index
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00651976
|United States, Georgia|
|Atlanta, Georgia, United States|
|United States, Oklahoma|
|Surgical Associates, Inc.|
|Tulsa, Oklahoma, United States, 74136|
|United States, Pennsylvania|
|Allegheny Cancer Center|
|Pittsburgh, Pennsylvania, United States, 15212|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center at Franklin|
|Nashville, Tennessee, United States, 37064|
|Vanderbilt-Ingram Cancer Center, One Hundred Oaks|
|Nashville, Tennessee, United States, 37204|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Principal Investigator:||Ingrid Meszoely, MD||Vanderbilt-Ingram Cancer Center|