Status unknownNCT01424865Updated May 8, 2015

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

An observational study in Breast Cancer, sponsored by NSABP Foundation Inc. Status unknown. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-08.

Sponsored by NSABP Foundation Inc · Observational

The sponsor has not verified this record recently (last verified May 2015), so the status shown — last known as Active, not recruiting — may be out of date.

Study type: Observational
Model: Case-control
Time perspective: Retrospective
Enrollment: 1,874
Ages: 18 Years and older
Sex: Female

Study 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.

Read the 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).

Conditions studied

Breast Cancer

Browse trials for

Breast Neoplasms 12,544

Keywords

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

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 1,874 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

NSABP Foundation Inc is the lead sponsor of 64 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Primary cancer tissue from participants in protocol NSABP B-31.

Eligibility 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

Study design

Observational model: Case-control
Time perspective: Retrospective
Enrollment: 1,874 participants (estimated)

Interventions

Geneticfluorescence in situ hybridization
Otherimmunohistochemistry staining method
Otherimmunologic technique
Otherlaboratory biomarker analysis

What researchers measure

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

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01424865
Lead sponsor: NSABP Foundation Inc
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Aug 29, 2011
Start date: Nov 2011
Primary completion: Dec 2015 (estimated)
Last update: May 8, 2015

Study contacts

Daniel F. Hayes, MD

principal investigator · University of Michigan Rogel Cancer Center

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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