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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

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NSABP Foundation Inc Identifier:
First received: August 26, 2011
Last updated: May 6, 2015
Last verified: May 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 Intervention
Breast Cancer
Genetic: fluorescence in situ hybridization
Other: immunohistochemistry staining method
Other: immunologic technique
Other: laboratory biomarker analysis

Study Type: Observational
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

Resource links provided by NLM:

Further study details as provided by NSABP Foundation Inc:

Primary Outcome Measures:
  • ALDH1 expression (percentage of stem cells within the tumor) and association with outcomes regardless of HER2 staining [ Time Frame: approximately 4 years ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1874
Study Start Date: November 2011
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Detailed Description:



  • 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).


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary cancer tissue from participants in protocol NSABP B-31.


  • 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


  • Not specified


  • See Disease Characteristics
  Contacts and Locations
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Please refer to this study by its identifier: NCT01424865

Sponsors and Collaborators
NSABP Foundation Inc
National Cancer Institute (NCI)
Principal Investigator: Daniel F. Hayes, MD University of Michigan Cancer Center
  More Information

Responsible Party: NSABP Foundation Inc Identifier: NCT01424865     History of Changes
Other Study ID Numbers: NSABP B-31 ICSCA
Study First Received: August 26, 2011
Last Updated: May 6, 2015

Keywords provided by NSABP Foundation Inc:
HER2-positive breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents processed this record on March 27, 2017