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BRCA1 and BRCA2 Mutations and Triple Negative Disease in Hispanic/Latino Breast Cancer Subjects


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Neoplasms

Thank you

Trial Information

BRCA1 and BRCA2 Mutations and Triple Negative Disease in Hispanic/Latino Breast Cancer Subjects


BACKGROUND:

- Mutations in the BRCA1 and BRCA2 genes predispose to breast and ovarian cancer, and are
increasingly recognized in prostate and pancreatic cancers.

- Basal/ Triple negative breast cancer is associated with BRCA mutations in some
ethnicities.However the link between BRCA gene mutations and Basil/ triple negative
disease in Hispanic/ Latino women is not known.

- Common recurrent mutations in BRCA1 and BRCA2 exist in Hispanic/ Latino communities.

- New therapies such as PARP inhibitors may be particularly effective in BRCA mutation
carriers.

- Therefore a unique opportunity exists to identify women in this underserved minority
that may be eligible for and benefit from new targeted therapies.

OBJECTIVES:

- The primary objective is to collect saliva samples and histology data from up to 2000
Hispanic/ Latino subjects with breast cancer as a source of DNA, and to analyze the BRCA1
and BRCA2 genes..

ELIGIBILITY:

- All Hispanics females, over the age of 18, with breast cancer will be eligible.

DESIGN:

- Natural history study of 2000 Hispanic/Latino women with breast cancer, 1000 with triple

negative disease, 1000 without.

- Obtain clinical pathology reports and relevant history data on all subjects.

- Analyze recurrent BRCA1 and BRCA2 mutations

Inclusion Criteria


- INCLUSION CRITERIA:

- Patient must be self-identified of Hispanic/Latino origin.

- Patients must have histologically or cytologically confirmed diagnosis of breast
cancer.

- Age greater than or equal to 18 years.

- Ability to understand and the willingness to sign a written informed consent
document.

- Must be willing and able to provide a saliva sample, answer questionnaire data online
or complete a paper questionnaire, and request a copy of their pathology report.

EXCLUSION CRITERIA:

- Males and subjects under the age of 18.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Michael Dean, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

999911035

NCT ID:

NCT01251900

Start Date:

November 2010

Completion Date:

Related Keywords:

  • Breast Neoplasms
  • Triple Negative Disease
  • BRCA1
  • BRCA2
  • Hispanic/Latino
  • Breast Cancer
  • Breast Neoplasms
  • Neoplasms

Name

Location

Texas Tech University Health Sciences Center University Health Sciences Center El Paso, Texas  
Southwest Cancer Treatment and Research Center, Lubbock; Texas Tech University Lubbock, Texas  79415