Breast Cancer Clinical Trial
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
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.
OBJECTIVES:
- 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.
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