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. 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
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NSABP Foundation Inc

Brief Summary:

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

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).

Study Type : Observational
Estimated Enrollment : 1874 participants
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
Study Start Date : November 2011
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab
U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01424865

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

Responsible Party: NSABP Foundation Inc Identifier: NCT01424865     History of Changes
Other Study ID Numbers: NSABP B-31 ICSCA
First Posted: August 29, 2011    Key Record Dates
Last Update Posted: May 8, 2015
Last Verified: May 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