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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01424865|
Recruitment Status : Unknown
Verified May 2015 by NSABP Foundation Inc.
Recruitment status was: Active, not recruiting
First Posted : August 29, 2011
Last Update Posted : May 8, 2015
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Genetic: fluorescence in situ hybridization Other: immunohistochemistry staining method Other: immunologic technique Other: laboratory biomarker analysis|
- 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).
|Study Type :||Observational|
|Estimated Enrollment :||1874 participants|
|Observational Model:||Case Control|
|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|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||December 2015|
- ALDH1 expression (percentage of stem cells within the tumor) and association with outcomes regardless of HER2 staining [ Time Frame: approximately 4 years ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01424865
|Principal Investigator:||Daniel F. Hayes, MD||University of Michigan Cancer Center|