S9313B Study of Tumor Tissue Samples From Women With Early-Stage Breast Cancer Enrolled on Clinical Trial SWOG-9313
|ClinicalTrials.gov Identifier: NCT00949013|
Recruitment Status : Completed
First Posted : July 30, 2009
Last Update Posted : May 26, 2014
RATIONALE: Studying samples of tumor 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. It may also help doctors predict how patients enrolled on clinical trial SWOG-9313 will respond to doxorubicin and cyclophosphamide.
PURPOSE: This laboratory study is looking at tumor tissue samples from women with early-stage breast cancer enrolled on clinical trial SWOG-9313.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Other: immunohistochemistry staining method Other: laboratory biomarker analysis|
- To determine if ALDH1 positivity, as determined by IHC staining, identifies a poor prognostic subgroup of women with early-stage breast cancer who have been uniformly treated with adjuvant doxorubicin and cyclophosphamide on clinical trial SWOG-9313.
- To determine associations of ALDH1 expression with other known factors that have been determined on clinical trial SWOG-9313, such as estrogen receptor (ER) status, HER2 status, TOPOII, cyclin E, and p27.
- To determine if ALDH1 positivity, as determined by IHC staining, identifies a poor prognostic subgroup within ER and HER2 subgroups in patients treated on clinical trial SWOG-9313.
OUTLINE: This is a multicenter study.
Tumor tissue samples from clinical trial SWOG-9313 are analyzed for ALDH1 expression by IHC.
|Study Type :||Observational|
|Actual Enrollment :||1600 participants|
|Official Title:||Evaluation of the Expression of the Cancer Stem Cell Marker ALDH1 as a Predictor of Adjuvant Chemotherapy Response in Breast Cancers of High Risk Women in SWOG-9313|
|Study Start Date :||January 2009|
|Primary Completion Date :||April 2009|
|Study Completion Date :||April 2009|
- Correlation of ALDH1 with disease-free survival and overall survival [ Time Frame: Retrospectively ]
- Correlation of ALDH1 with other biomarkers (TOPOII, HER2, ER, PgR) [ Time Frame: Retrospectively ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00949013
|Study Chair:||Daniel F. Hayes, MD||University of Michigan Cancer Center|