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Completed

NCT Number: NCT00949013

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Treatment and study plan

immunohistochemistry staining method

Other

laboratory biomarker analysis

Other

Primary outcomes

  1. Correlation of ALDH1 with disease-free survival and overall survival

    Time frame: Retrospectively

Secondary outcomes

  1. Correlation of ALDH1 with other biomarkers (TOPOII, HER2, ER, PgR)

    Time frame: Retrospectively

Sponsors and collaborators

Lead sponsor

SWOG Cancer Research Network

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 30, 2009
Registry last updated
May 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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