S9313A Protein Expression in Predicting Response to Treatment Using Tumor Tissue Samples From Women With Stage I, Stage II, or Stage IIIA Breast Cancer Treated on Clinical Trial SWOG-9313
|ClinicalTrials.gov Identifier: NCT00896727|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : October 7, 2016
RATIONALE: Studying the proteins expressed in tumor tissue samples in the laboratory from patients with cancer may help doctors learn more about biomarkers related to cancer. It may also help doctors predict how patients respond to treatment.
PURPOSE: This laboratory study is looking at protein expression in predicting response to treatment using tumor tissue samples from women with stage I, stage II, or stage IIIA breast cancer treated on clinical trial SWOG-9313.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Genetic: gene expression analysis Genetic: protein expression analysis Other: fluorescent antibody technique Other: laboratory biomarker analysis|
- Assess in-situ protein expression of estrogen receptor (ER), progesterone receptor (PR), HER-2, and p53 by automated quantitative analysis (AQUA™) and multiplexed analysis at 2 markers per slide using tumor tissue from women with stage I, stage II, or stage IIIA breast cancer treated on clinical trial SWOG-9313.
- Assess the main effects of ER, PR, HER-2, and p53, as well as interactions to generate classes formed by clustering of biomarkers, on a large breast cancer tissue microarray to predict disease-free and overall survival of patients who received high-dose cyclophosphamide and doxorubicin hydrochloride on clinical trial SWOG-9313.
OUTLINE: This is a multicenter study. Patients are stratified according to receptor status and menopausal status.
Tumor tissue samples are analyzed by quantitative protein expression analysis (AQUA™, a fluorescent antibody technique) for estrogen receptor, progesterone receptor, p53 and HER-2. AQUA™ is used to assess markers individually and as ratios with the use of clustering algorithms to define reproducible classifications of tissue from patients treated on SWOG-9313 as a function of molecular classification.
Results of the AQUA™ testing are compared to immunohistochemistry and fluorescent in situ hybridization (FISH) results obtained on SWOG-9313.
|Study Type :||Observational|
|Actual Enrollment :||2100 participants|
|Official Title:||Prediction of Therapeutic Response Using AQUA™ Quantitative Protein Expression Analysis of ER, PgR, and HER2 of Breast Cancer Tissue Microarrays From SWOG Protocol 9313|
|Study Start Date :||July 2006|
|Primary Completion Date :||December 2006|
|Study Completion Date :||December 2006|
- In-situ protein expression of estrogen receptor (ER), progesterone receptor (PR), HER-2, and p53 as measured by automated quantitative analysis (AQUA™) [ Time Frame: Retrospectively at baseline ]at baseline
- Main effects of ER, PR, HER-2, and p53, as well as interactions to generate classes formed by clustering of biomarkers, on a large breast cancer tissue microarray to predict disease-free and overall survival [ Time Frame: Retrospectively at baseline ]at baseline
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896727
|United States, Connecticut|
|Yale Cancer Center|
|New Haven, Connecticut, United States, 06520-8028|
|Principal Investigator:||David Rimm, MD||Yale University|