This trial is active, not recruiting.

Condition breast cancer
Treatments fluorescence in situ hybridization, immunohistochemistry staining method, immunologic technique, laboratory biomarker analysis
Sponsor NSABP Foundation Inc
Collaborator National Cancer Institute (NCI)
Start date November 2011
End date December 2015
Trial size 1874 participants
Trial identifier NCT01424865, NSABP B-31 ICSCA, NSABP-B31-ICSC-A


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.

United States Pennsylvania
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective retrospective

Primary Outcomes

ALDH1 expression (percentage of stem cells within the tumor) and association with outcomes regardless of HER2 staining
time frame: approximately 4 years

Secondary Outcomes

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

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

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
Principal investigator Daniel F. Hayes, MD
Description 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).
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by NSABP Foundation Inc.
Location data was received from the National Cancer Institute and was last updated in June 2016.