Biomarkers in Native American Women With Breast Cancer

Breast Cancer Clinical Trial

Official title:

Molecular Markers in Native American Women With Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00898976
• Other study ID #: NCCTG-97-95-51
• Secondary ID: NCCTG-979551CDR0
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: July 12, 2016
• Start date: August 1998
• Est. completion date: May 2007

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

RATIONALE: Studying samples of tumor tissue in the laboratory from Native American women with breast cancer may help doctors identify and learn more about biomarkers related to breast cancer in these patients. It may also help doctors learn more about the prognosis of these patients.

PURPOSE: This laboratory study is looking at biomarkers in Native American women with breast cancer.

Description:

OBJECTIVES:

• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• immunohistochemistry staining method

• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of a selected panel of molecular markers in tissue specimens from Native American women with breast cancer		Up to 5 years	No
Primary	Determination of which molecular markers provide independent prognostic information with respect to traditional prognostic factors		Up to 5 years	No
Primary	Comparison of 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		Up to 5 years	No