Cancer Stem Cell Biomarkers as a Predictor of Response to Trastuzumab in Samples From Patients With Breast Cancer Previously Treated in the NSABP-B-31 Trial
RATIONALE: Studying samples of 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.
PURPOSE: This research trial studies biomarkers as a predictor of response to trastuzumab in samples from patients with breast cancer previously treated in the NSABP-B-31 trial.
Genetic: fluorescence in situ hybridization
Other: immunohistochemistry staining method
Other: immunologic technique
Other: laboratory biomarker analysis
|Study Design:||Observational Model: Case Control
Time Perspective: Retrospective
|Official Title:||Evaluation of the Co-Expression of the Cancer Stem Cell Marker ALDH1 and of HER2 as a Predictor of Adjuvant Trastuzumab Response in Breast Cancers of Women in NSABP B31|
- ALDH1 expression (percentage of stem cells within the tumor) and association with outcomes regardless of HER2 staining [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
- HER2 expression in cells with stem cell-like properties as a determinant of aggressiveness and response to trastuzumab in the adjuvant setting [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
|Study Start Date:||November 2011|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
- To determine if stem cellness identifies a poor prognostic subgroup of women with early-stage breast cancer who have been uniformly treated with either adjuvant doxorubicin hydrochloride & cyclophosphamide followed by paclitaxel (the "control arm" of B31), or the same chemotherapy plus trastuzumab.
- To conduct exploratory analyses to assess, to the extent possible, if co-localization of stem cellness, as determined by ALDH1 positivity, and HER2 identifies a group of patients previously considered to have HER2-negative cancers (using classical definitions) who benefit from adjuvant trastuzumab.
OUTLINE: Archived breast cancer stem cells samples and terminally differentiated cells from tissue samples are analyzed for HER2 and ALDH1 expression by dual-staining quantitative immunofluorescence using Automated Quantitative Analysis (AQUA) , IHC, and fluorescence in situ hybridization (FISH).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424865
|Principal Investigator:||Daniel F. Hayes, MD||University of Michigan Cancer Center|