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| ID | Type | Description | Link |
|---|---|---|---|
| S8814A-ICSC | Other Identifier | SWOG | |
| GHI-01-024 | Other Identifier | Genomic Health | |
| U10CA032102 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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 patients will respond to treatment.
PURPOSE: This laboratory study is looking at biomarkers in predicting outcome in postmenopausal women with hormone receptor-positive, node-positive breast cancer treated with tamoxifen with or without cyclophosphamide, doxorubicin, and fluorouracil.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Fixed paraffin-embedded breast tumor tissue samples (obtained from the SWOG Central Tumor Repository at the University of Colorado) are analyzed by the Oncotype DX panel containing the following 21 genes: BAG1, Bc12, CCNB1, CD68, SCUBE2, CTSL2, Esrt1, GRB7, GSTM1, HER2, Ki-67, MYBL2, PR, STK15, STMY3, SURV, B-actin, GAPDH, GUS, RPLPO, and TFRC. The Oncotype DX Recurrence Score is calculated for each patient. Analyses are performed to determine the relationship between the Recurrence Score and gene expression and prognosis/prediction of therapy (tamoxifen citrate alone or cyclophosphamide, doxorubicin hydrochloride, and fluorouracil with concurrent or sequential tamoxifen citrate) benefit as well as to determine the relationship between clinical and demographic covariates and disease-free and overall survival.
Samples are also analyzed by reverse-transcriptase-polymerase chain reaction for exploratory analysis of up to 800 additional genes that may be prognostic and/or predict the likelihood of therapy benefit.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comparative genomic hybridization | Genetic | |||
| microarray analysis | Genetic | |||
| reverse transcriptase-polymerase chain reaction | Genetic | |||
| diagnostic laboratory biomarker analysis | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | ||
| Overall survival |
| Measure | Description | Time Frame |
|---|---|---|
| Distant disease-free recurrence |
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DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Previously enrolled in SWOG-8814, a treatment clinical trial, and in SWOG-9445, a companion tissue banking study
Tumor block or unstained sections available from initial diagnosis in the SWOG archive
Sufficient RNA (≥ 300 ng) for RT-PCR analysis with the Oncotype DX 21 gene assay
Average normalized cycle threshold for the 5 reference genes ≤ 35
Follow-up data from the SWOG-8814 clinical trial obtained from the patient
Hormone receptor status:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Patients consenting to banking in S8814
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| Name | Affiliation | Role |
|---|---|---|
| Kathy S. Albain, MD | Loyola University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D055028 | Comparative Genomic Hybridization |
| D046228 | Microarray Analysis |
| D020133 | Reverse Transcriptase Polymerase Chain Reaction |
| ID | Term |
|---|---|
| D020732 | Cytogenetic Analysis |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D025202 | Molecular Diagnostic Techniques |
| D009693 | Nucleic Acid Hybridization |
| D046208 | Microchip Analytical Procedures |
| D016133 | Polymerase Chain Reaction |
| D021141 | Nucleic Acid Amplification Techniques |
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