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
| Registry | NCT01424865 |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 1874 (Estimated) |
| Sponsor | NSABP Foundation Inc (Network); collaborators: National Cancer Institute (NCI) |
| Conditions | Breast Cancer |
| Interventions | fluorescence in situ hybridization, immunohistochemistry staining method, immunologic technique, laboratory biomarker analysis (Genetic, other) |
| Dates | start 2011-11-01, primary completion 2015-12-01 (estimated), first posted 2011-08-29, last updated 2015-05-08 |
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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.
OBJECTIVES:
Primary
* 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.
Secondary
* 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).
Sex: Female, ages: 18 Years to any
DISEASE CHARACTERISTICS: * Tissue samples from patients with node-positive breast cancer whose tumors overexpress HER2 * Primary tumor samples that are negative for HER2 using classically accepted cutoffs determined in the metastatic setting * Treated with adjuvant therapy comprising doxorubicin hydrochloride, cyclophosphamide, and paclitaxel with or without trastuzumab in the NSABP-B-31 trial PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics