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S9313B Study of Tumor Tissue Samples From Women With Early-Stage Breast Cancer Enrolled on Clinical Trial SWOG-9313

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00949013
Recruitment Status : Completed
First Posted : July 30, 2009
Last Update Posted : May 26, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

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.

Condition or disease Intervention/treatment
Breast Cancer Other: immunohistochemistry staining method Other: laboratory biomarker analysis

Detailed Description:



  • 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
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Correlation of ALDH1 with disease-free survival and overall survival [ Time Frame: Retrospectively ]

Secondary Outcome Measures :
  1. Correlation of ALDH1 with other biomarkers (TOPOII, HER2, ER, PgR) [ Time Frame: Retrospectively ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients enrolled to S9313 consenting to banking


  • Tumor samples collected from women diagnosed with early-stage breast cancer on clinical trial SWOG-9313 available


  • Not specified


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00949013

Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Daniel F. Hayes, MD University of Michigan Cancer Center

Responsible Party: Southwest Oncology Group Identifier: NCT00949013     History of Changes
Other Study ID Numbers: CDR0000632885
S9313B-ICSC ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: July 30, 2009    Key Record Dates
Last Update Posted: May 26, 2014
Last Verified: May 2014

Keywords provided by Southwest Oncology Group:
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases