Study of Tissue Samples From Women Treated With Paclitaxel for Breast Cancer on Clinical Trial CALGB-9344 or CALGB-9741
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|ClinicalTrials.gov Identifier: NCT00991263|
Recruitment Status : Completed
First Posted : October 7, 2009
Last Update Posted : August 8, 2017
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Genetic: gene expression analysis Genetic: polymerase chain reaction Other: laboratory biomarker analysis|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||3677 participants|
|Official Title:||Intrinsic Breast Cancer Subtypes and Benefit of Paclitaxel in CALGB 9344 and Dose Dense Therapy in CALGB 9741|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||February 2012|
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|
- Disease-free survival (DFS) [ Time Frame: Up to 10 years ]
- 5- and 10-year DFS rates [ Time Frame: Up to 10 years ]
- Overall survival [ Time Frame: Up to 10 years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00991263
|Study Chair:||Matthew J. Ellis, MD, PhD, FRCP||Washington University Siteman Cancer Center|