Biomarkers in Predicting Response to Tamoxifen and Letrozole in Postmenopausal Women With Primary Breast Cancer Treated on Clinical Trial CAN-NCIC-MA17
NCT ID: NCT00897065
Last Updated: 2013-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
957 participants
OBSERVATIONAL
2006-06-30
Brief Summary
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PURPOSE: This laboratory study is looking at biomarkers that may predict response to tamoxifen and letrozole in postmenopausal women with primary breast cancer treated on clinical trial CAN-NCIC-MA17.
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Detailed Description
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* Assess the prognostic utility of the MGH 2-gene and the GHI 21-gene expression signatures in postmenopausal women with primary breast cancer treated with tamoxifen followed by either placebo or letrozole on clinical trial CAN-NCIC-MA17.
* Assess the ability of the MGH 2-gene and the GHI 21-gene expression signatures to predict responsiveness to letrozole.
* Compare the prognostic utility of quantitative immunofluorescence vs standard immunohistochemistry of estrogen receptor, progesterone receptor, HER-2, tumor aromatase, cyclooxygenase-2, GATA-3, and NAT-1 in these patients.
* Assess the ability of quantitative immunofluorescence and standard immunohistochemistry of these proteins to predict responsiveness to letrozole in these patients.
* Use gene discovery from formalin-fixed, paraffin-embedded tumor specimens to identify novel gene expression profiles that may predict outcome and responsiveness to letrozole in these patients.
OUTLINE: This is a controlled study.
Formalin-fixed, paraffin-embedded breast tumor tissue samples are analyzed for MGH 2-gene and GHI 21-gene expression signatures using real-time quantitative polymerase chain reaction. Immunohistochemistry and immunofluorescence are used for analysis of estrogen receptor, progesterone receptor, HER-1 and -2, aromatase, GATA-3, NAT-1, and cyclooxygenase-2. Microarray hybridization is used to identify novel gene expression signatures.
PROJECTED ACCRUAL: A total of 957 specimens will be accrued for this study.
Conditions
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Interventions
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microarray analysis
polymerase chain reaction
protein expression analysis
diagnostic laboratory biomarker analysis
fluorescent antibody technique
immunohistochemistry staining method
immunologic technique
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed primary invasive breast carcinoma resected at time of original diagnosis
* Treated on clinical trial CAN-NCIC-MA17
* Hormone receptor status:
* Estrogen or progesterone receptor positive tumor
PATIENT CHARACTERISTICS:
* Female
* Postmenopausal
PRIOR CONCURRENT THERAPY:
* Not specified
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Massachusetts General Hospital
OTHER
Principal Investigators
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Paul E. Goss, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Facility Contacts
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Clinical Trials Office - Massachusetts General Hospital
Role: primary
Other Identifiers
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CDR0000466578
Identifier Type: REGISTRY
Identifier Source: secondary_id
MGH-MA.17ICSC
Identifier Type: -
Identifier Source: org_study_id
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