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
NCT ID: NCT01424865
Last Updated: 2015-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1874 participants
OBSERVATIONAL
2011-11-30
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Interventions
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fluorescence in situ hybridization
immunohistochemistry staining method
immunologic technique
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
NSABP Foundation Inc
NETWORK
Responsible Party
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Principal Investigators
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Daniel F. Hayes, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Rogel Cancer Center
Other Identifiers
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NSABP-B31-ICSC-A
Identifier Type: -
Identifier Source: secondary_id
NSABP B-31 ICSCA
Identifier Type: -
Identifier Source: org_study_id
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