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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01424865

Enrollment

1874

Registered

2011-08-29

Start date

2011-11-30

Completion date

Unknown

Last updated

2015-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

HER2-positive breast cancer, stage II breast cancer, stage IIIA breast cancer

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.

Detailed 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).

Interventions

GENETICfluorescence in situ hybridization

OTHERimmunohistochemistry staining method

OTHERimmunologic technique

OTHERlaboratory biomarker analysis

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
HER2 expression in cells with stem cell-like properties as a determinant of aggressiveness and response to trastuzumab in the adjuvant setting	approximately 4 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026