Breast NeoplasmsNCT01251900
BRCA Mutations in Latinas
An observational study of Breast Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: BRCA1 and BRCA2 gene mutations have been linked to a higher risk of developing breast cancer and other cancers, and may be associated with types of breast cancer that are more difficult to treat and more likely to recur. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Neoplasms
- How many people
- 266 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2011to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: primary clinical
Who may be able to join
- 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.
Who cannot join
- Males and subjects under the age of 18.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southwest Cancer Center, Lubbock; Texas Tech University
Lubbock, Texas, 79415
About this study
Official title: BRCA1 and BRCA2 Mutations and Triple Negative Disease in Hispanic/Latino Breast Cancer Subjects
Background:
- BRCA1 and BRCA2 gene mutations have been linked to a higher risk of developing breast cancer and other cancers, and may be associated with types of breast cancer that are more difficult to treat and more likely to recur. New cancer treatments are being developed specifically to treat individuals who have these gene mutations. However, more information is needed about the prevalence of these mutations in minority populations, including Hispanic/Latino populations. To study these populations, researchers are interested in collecting genetic material (DNA) and medical history information from Hispanic/Latino women who have been diagnosed with breast cancer.
Read more
Objectives:
- To collect saliva samples and medical and family history information from Hispanic/Latino women with breast cancer.
Eligibility:
- Hispanic/Latino women at least 18 years of age who have been diagnosed with breast cancer.
Design:
- Participants will complete a questionnaire with information about place of birth, languages spoken by parents and grandparents, and information about their breast cancer diagnosis.
- Participants will provide a saliva sample (2 to 3 tablespoons) for analysis.
- No treatment will be provided as part of this protocol.
Read the detailed description
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
- Conditions
- Breast Neoplasms
- Keywords
- Triple Negative Disease, BRCA1, BRCA2, Hispanic/Latino, Breast Cancer, Natural History
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Hispanic women, over the age of 18, with breast cancer will be eligible. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of saliva from 2000 probands
Measured: Every six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study start7 Jul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Michael C Dean, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251900
- Sponsor's protocol ID
- 999911035
- Other IDs
- 11-C-N035
- Status last verified
- 25 Sep 2025
- First submitted
- 1 Dec 2010
- Last updated
- 4 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dean M, Boland J, Yeager M, Im KM, Garland L, Rodriguez-Herrera M, Perez M, Mitchell J, Roberson D, Jones K, Lee HJ, Eggebeen R, Sawitzke J, Bass S, Zhang X, Robles V, Hollis C, Barajas C, Rath E, Arentz C, Figueroa JA, Nguyen DD, Nahleh Z. Addressing health disparities in Hispanic breast cancer: accurate and inexpensive sequencing of BRCA1 and BRCA2. Gigascience. 2015 Nov 4;4:50. doi: 10.1186/s13742-015-0088-z. eCollection 2015.
PubMed 26543556
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRCA1 and BRCA2 Mutations and Triple Negative Disease in Hispanic/Latino Breast Cancer Subjects
- ClinicalTrials.gov ID
- NCT01251900
- Acronym / sponsor ID
- 999911035
- Conditions
- Breast Neoplasms
- Keywords
- Triple Negative Disease, BRCA1, BRCA2, Hispanic/Latino, Breast Cancer, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 7 Jul 2011 (actual)
- First posted
- 2 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- BRCA1 and BRCA2 gene mutations have been linked to a higher risk of developing breast cancer and other cancers, and may be associated with types of breast cancer that are more difficult to treat and more likely to recur. New cancer treatments are being developed specifically to treat individuals who have these gene mutations. However, more information is needed about the prevalence of these mutations in minority populations, including Hispanic/Latino populations. To study these populations, researchers are interested in collecting genetic material (DNA) and medical history information from Hispanic/Latino women who have been diagnosed with breast cancer.
Objectives:
- To collect saliva samples and medical and family history information from Hispanic/Latino women with breast cancer.
Eligibility:
- Hispanic/Latino women at least 18 years of age who have been diagnosed with breast cancer.
Design:
- Participants will complete a questionnaire with information about place of birth, languages spoken by parents and grandparents, and information about their breast cancer diagnosis.
- Participants will provide a saliva sample (2 to 3 tablespoons) for analysis.
- No treatment will be provided as part of this protocol.
Detailed description
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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Hispanic women, over the age of 18, with breast cancer will be eligible. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary clinical
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Males and subjects under the age of 18.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Collection of saliva from 2000 probands
Time frame: Every six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Background: PubMed 26543556Dean M, Boland J, Yeager M, Im KM, Garland L, Rodriguez-Herrera M, Perez M, Mitchell J, Roberson D, Jones K, Lee HJ, Eggebeen R, Sawitzke J, Bass S, Zhang X, Robles V, Hollis C, Barajas C, Rath E, Arentz C, Figueroa JA, Nguyen DD, Nahleh Z. Addressing health disparities in Hispanic breast cancer: accurate and inexpensive sequencing of BRCA1 and BRCA2. Gigascience. 2015 Nov 4;4:50. doi: 10.1186/s13742-015-0088-z. eCollection 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael C Dean, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of saliva from 2000 probands (time frame: Every six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01251900, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.