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Clinical Trials/NCT00949013
NCT00949013
Completed
Not Applicable

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

SWOG Cancer Research Network0 sites1,600 target enrollmentJanuary 2009
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
SWOG Cancer Research Network
Enrollment
1600
Primary Endpoint
Correlation of ALDH1 with disease-free survival and overall survival
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

Detailed Description

OBJECTIVES: Primary * 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. Secondary * 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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
April 2009
Last Updated
11 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Correlation of ALDH1 with disease-free survival and overall survival

Time Frame: Retrospectively

Secondary Outcomes

  • Correlation of ALDH1 with other biomarkers (TOPOII, HER2, ER, PgR)(Retrospectively)

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