Biomarkers in Predicting Response to Tamoxifen and Letrozole in Postmenopausal Women With Primary Breast Cancer Treated on Clinical Trial CAN-NCIC-MA17

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00897065

Collaborator

National Cancer Institute (NCI) (NIH)

957

Enrollment

Location

Study Details

Study Description

Brief Summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients respond to treatment.

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Genetic: microarray analysis Genetic: polymerase chain reaction Genetic: protein expression analysis Other: diagnostic laboratory biomarker analysis Other: fluorescent antibody technique Other: immunohistochemistry staining method Other: immunologic technique

Detailed Description

OBJECTIVES:

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

957 participants

Official Title:

Quantitative Protein and Gene Expression Biomarkers of Tamoxifen and Letrozole Recurrence in the NCIC CTG MA.17 Cohort

Study Start Date :

Jun 1, 2006

Outcome Measures

Primary Outcome Measures

Prognostic utility of the MGH 2-gene and the GHI 21-gene expression signatures []
Ability of the MGH 2-gene and the GHI 21-gene expression signatures to predict responsiveness to letrozole []
Prognostic utility of quantitative immunofluorescence vs standard immunohistochemistry of estrogen receptor, progesterone receptor, HER-2, tumor aromatase, cyclooxygenase-2, GATA-3, and NAT-1 []
Ability of quantitative immunofluorescence and standard immunohistochemistry of these proteins to predict responsiveness to letrozole []
Novel gene expression profiles that may predict outcome and responsiveness to letrozole []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

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