Trials / Unknown
UnknownNCT01424865
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,874 (estimated)
- Sponsor
- NSABP Foundation Inc · Network
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | fluorescence in situ hybridization | |
| OTHER | immunohistochemistry staining method | |
| OTHER | immunologic technique | |
| OTHER | laboratory biomarker analysis |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2015-12-01
- First posted
- 2011-08-29
- Last updated
- 2015-05-08
Source: ClinicalTrials.gov record NCT01424865. Inclusion in this directory is not an endorsement.