Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
120 participants
OBSERVATIONAL
1998-08-31
2007-05-31
Brief Summary
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PURPOSE: This laboratory study is looking at biomarkers in Native American women with breast cancer.
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Detailed Description
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* Evaluate a selected panel of molecular markers in tissue specimens from Native American women with breast cancer.
* Determine which molecular markers provide independent prognostic information with respect to traditional prognostic factors in these patients.
* Compare and contrast the prevalence of positivity in Native American women with breast cancer with an age- and stage-matched cohort of Caucasian women with breast cancer enrolled on clinical trial NCCTG-77-30-51 or the Mayo Breast Cancer Registry.
OUTLINE: Immunohistochemistry is performed on tumor samples to analyze the following molecular markers: estrogen receptor, progesterone receptor, c-erbB2, p53, Ki-67, Bcl-2, Bax, cyclin D-1, and insulin-like growth factor-1R.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Group I
Immunohistochemistry is performed on tumor samples to analyze the following molecular markers: estrogen receptor, progesterone receptor, c-erbB2, p53, Ki-67, Bcl-2, Bax, cyclin D-1, and insulin-like growth factor-1R. PROJECTED ACCRUAL: A total of 300 tissue samples (150 from Native American women and 150 from Caucasian women) will be accrued for this study.
immunohistochemistry staining method
laboratory biomarker analysis
Interventions
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immunohistochemistry staining method
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of primary adenocarcinoma of the breast in Native American women
* Prior surgical treatment for breast cancer within the Aberdeen or Phoenix areas of the Indian Health Service or the Alaska area of the Native Health Service between 1990-2000
* Paraffin-embedded tissue available
* Paraffin-embedded tissue available from Caucasian women with breast cancer enrolled on NCCTG-77-30-51 or the Mayo Breast Cancer Registry
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Female
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Judith S. Kaur, MD
Role: STUDY_CHAIR
Mayo Clinic
Other Identifiers
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NCCTG-979551
Identifier Type: -
Identifier Source: secondary_id
CDR0000078596
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2013-00323
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCCTG-97-95-51
Identifier Type: -
Identifier Source: org_study_id
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