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
- 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).
ALDH1 expression (percentage of stem cells within the tumor) and association with outcomes regardless of HER2 staining
Daniel F. Hayes, MD
University of Michigan Cancer Center
United States: Federal Government