Study of Tissue Samples From Women Treated With Paclitaxel for Breast Cancer on Clinical Trial CALGB-9344 or CALGB-9741
RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer.
PURPOSE: This research study is looking at tissue samples from women treated with paclitaxel for breast cancer on clinical trial CALGB 9344 or CALGB 9741.
Genetic: gene expression analysis
Genetic: polymerase chain reaction
Other: laboratory biomarker analysis
|Study Design:||Observational Model: Case-Only
Time Perspective: Retrospective
|Official Title:||Intrinsic Breast Cancer Subtypes and Benefit of Paclitaxel in CALGB 9344 and Dose Dense Therapy in CALGB 9741|
- Disease-free survival (DFS) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
- 5- and 10-year DFS rates [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Tumor tissue samples
|Study Start Date:||April 2009|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Tissue blocks from CALGB-9344 and CALGB-9741 are utilized to purify RNA to be tested in the PAM50 assay (a 50-gene quantitative PCR assay, that provides an intrinsic breast cancer subtype diagnosis) and generate risk of relapse (ROR) scores. For more information, see Details section.
|Genetic: gene expression analysis Genetic: polymerase chain reaction Other: laboratory biomarker analysis|
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00991263
|Study Chair:||Matthew J. Ellis, MD, PhD, FRCP||Washington University Siteman Cancer Center|