Breast NeoplasmsSTAR-BREASTNCT07070128
Screening Tool Artificial Intelligence-based for Predicting the Genetic Risk of BREAST Cancer
An observational study of Breast Neoplasms, run by AstraZeneca at 3 sites in Brazil.
Trial summary
It is a retrospective observational study that will include female patients aged 18 years or older, who were treated between 2017 and 2024, in both public and private institutions, and identified as at high genetic risk by breast specialists and referred to a geneticist. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Neoplasms
- How many people
- 800 participants
- Where
- 3 sitesBrazil
- Study dates
- 20 Aug 2025to 11 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Convenience sampling will be performed, inviting all women treated at both institutions from January 2017 to June 2024 who have been considered by breast surgeons as genetic risk patients and have undergone genetic testing with a geneticist, regardless of whether they have invasive breast carcinoma.
Who may be able to join
- female patients,
- aged 18 years or older,
- identified as high genetic risk by breast surgeons,
- referred to a geneticist, and
- who agree to participate in the study.
Who cannot join
- male patients,
- absence of complete information in the medical records,
- patients unaware of their biological family history, and
- patients who do not agree to participate in the study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
Brazil3 sites, 2 recruiting
- Withdrawn
Research Site
Golania, Goiás, 74605-020
- Recruiting
Research Site
Porto Alegre, Rio Grande do Sul, 90035-001
- Not yet recruiting
Research Site
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Screening Tool Artificial Intelligence-based for Predicting the Genetic Risk of BREAST Cancer (STAR-BREAST)
It is a retrospective observational study that will include female patients aged 18 years or older, who were treated between 2017 and 2024, in both public and private institutions, and identified as at high genetic risk by breast specialists and referred to a geneticist. The artificial intelligence-based tool to be used in this study is developed by the startup WeConecta, which will collect data via WhatsApp about the patients' family cancer history with the aim of predicting the genetic risk of developing breast cancer.
Read the detailed description
This is an observational retrospective study. Patients considered by mastologists to be at genetic risk and who have undergone genetic testing with a geneticist will have their electronic medical records reviewed and, if eligible for the study, will answer questions conducted by the virtual assistant using AI about their family history of cancer.
This study will be conducted in two centers. The first is the Breast Center at Hospital Moinhos de Vento, designated as the coordinating center, located in Porto Alegre, Rio Grande do Sul, Brazil. It is a private center composed of a multidisciplinary team dedicated to breast health care, from routine exams for early detection of malignant tumors, diagnosis, comprehensive treatment at different stages of the disease, to post-treatment follow-up. The second center, designated as a participant, is the Human Genetics Center (CEGH/ICB), located in Goiânia, Brazil. This entity works interdisciplinarily and is linked to the Institute of Biological Sciences at the Federal University of Goiás (UFG), with the aim of developing activities in diagnosis, education, research, and outreach in the field of human genetics.
CEGH/ICB is a public institution that serves women with breast cancer from the Unified Health System (SUS), and its role in the research is to share collected data from the population of interest with the coordinating center.
- Conditions
- Breast Neoplasms
- Keywords
- Breast Cancer, Artificial Intelligence, Genetic Risk
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between AI tool results and genetic test results
Implement the use of an artificial intelligence (AI)-based tool, WeConecta, to predict the genetic risk of hereditary breast cancer in women treated at a private and public institution, including analyses of the sensitivity, specificity, and positive and negative predictive values of the tool in comparison with the results of the genetic test. Hypothesis: The artificial intelligence (AI)-based tool may present a strong level of agreement regarding the indication for genetic counseling in relation to the indication of mastologists, impacting genetic testing.
Measured: Through study completion, an average at one year.
Secondary outcomes (6)
Evaluate the rate of agreement between the AI tool and the breast surgeon
Comparison between the number of participants who were indicated to genetic counseling through the AI tool and according to the opinion of the mastologist
Measured: Through study completion, an average at one year.
Agreement between hereditary breast cancer risk identified by the AI tool and the results of genetic testing.
To assess how many patients were identified by the AI tool as having "hereditary breast cancer risk" and how closely they agreed with the actual number obtained from genetic testing results.
Measured: Through study completion, an average at one year.
Describe the rate of family history profile of women at high risk for breast cancer
Describe the rate of family history profile of women at high risk for breast cancer
Measured: Through study completion, an average at one year.
Examine the rate of high penetrance variants
Examine the rate of high penetrance variants.
Measured: Through study completion, an average at one year.
Describe the rate of profile of patients with confirmed BRCA1 and BRCA2 variants
Describe the rate of profile of patients with confirmed BRCA1 and BRCA2 variants
Measured: Through study completion, an average at one year.
Compare the rate of patient profiles between the two institutions
Compare the rate of patients with pathogenic variants and genetic risk of breast cancer between the two institutions involved in the study.
Measured: Through study completion, an average at one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start20 Aug 2025
- Primary completion11 Aug 2026 (estimated)
- Study completion11 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070128
- Sponsor's protocol ID
- D0817R00113
- Acronym
- STAR-BREAST
- Status last verified
- Jul 2026
- First submitted
- 16 Apr 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Tool Artificial Intelligence-based for Predicting the Genetic Risk of BREAST Cancer (STAR-BREAST)
- ClinicalTrials.gov ID
- NCT07070128
- Acronym / sponsor ID
- STAR-BREAST / D0817R00113
- Conditions
- Breast Neoplasms
- Keywords
- Breast Cancer, Artificial Intelligence, Genetic Risk
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 11 Aug 2026 (estimated)
- Study completion
- 11 Aug 2026 (estimated)
- First posted
- 17 Jul 2025 (actual)
- 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.
It is a retrospective observational study that will include female patients aged 18 years or older, who were treated between 2017 and 2024, in both public and private institutions, and identified as at high genetic risk by breast specialists and referred to a geneticist. The artificial intelligence-based tool to be used in this study is developed by the startup WeConecta, which will collect data via WhatsApp about the patients' family cancer history with the aim of predicting the genetic risk of developing breast cancer.
Detailed description
This is an observational retrospective study. Patients considered by mastologists to be at genetic risk and who have undergone genetic testing with a geneticist will have their electronic medical records reviewed and, if eligible for the study, will answer questions conducted by the virtual assistant using AI about their family history of cancer.
This study will be conducted in two centers. The first is the Breast Center at Hospital Moinhos de Vento, designated as the coordinating center, located in Porto Alegre, Rio Grande do Sul, Brazil. It is a private center composed of a multidisciplinary team dedicated to breast health care, from routine exams for early detection of malignant tumors, diagnosis, comprehensive treatment at different stages of the disease, to post-treatment follow-up. The second center, designated as a participant, is the Human Genetics Center (CEGH/ICB), located in Goiânia, Brazil. This entity works interdisciplinarily and is linked to the Institute of Biological Sciences at the Federal University of Goiás (UFG), with the aim of developing activities in diagnosis, education, research, and outreach in the field of human genetics.
CEGH/ICB is a public institution that serves women with breast cancer from the Unified Health System (SUS), and its role in the research is to share collected data from the population of interest with the coordinating center.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Convenience sampling will be performed, inviting all women treated at both institutions from January 2017 to June 2024 who have been considered by breast surgeons as genetic risk patients and have undergone genetic testing with a geneticist, regardless of whether they have invasive breast carcinoma.
Key inclusion criteria (5 listed)
- female patients,
- aged 18 years or older,
- identified as high genetic risk by breast surgeons,
- referred to a geneticist, and
- who agree to participate in the study.
Key exclusion criteria (4 listed)
- male patients,
- absence of complete information in the medical records,
- patients unaware of their biological family history, and
- patients who do not agree to participate in the study.
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
Agreement between AI tool results and genetic test results
Time frame: Through study completion, an average at one year.
Implement the use of an artificial intelligence (AI)-based tool, WeConecta, to predict the genetic risk of hereditary breast cancer in women treated at a private and public institution, including analyses of the sensitivity, specificity, and positive and negative predictive values of the tool in comparison with the results of the genetic test. Hypothesis: The artificial intelligence (AI)-based tool may present a strong level of agreement regarding the indication for genetic counseling in relation to the indication of mastologists, impacting genetic testing.
6 secondary outcomes
Evaluate the rate of agreement between the AI tool and the breast surgeon
Time frame: Through study completion, an average at one year.
Agreement between hereditary breast cancer risk identified by the AI tool and the results of genetic testing.
Time frame: Through study completion, an average at one year.
Describe the rate of family history profile of women at high risk for breast cancer
Time frame: Through study completion, an average at one year.
Examine the rate of high penetrance variants
Time frame: Through study completion, an average at one year.
Describe the rate of profile of patients with confirmed BRCA1 and BRCA2 variants
Time frame: Through study completion, an average at one year.
Compare the rate of patient profiles between the two institutions
Time frame: Through study completion, an average at one year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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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.
AstraZeneca Clinical Study Information Center contact
3 sites 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 AstraZeneca at 3 sites in Brazil.
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 4 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: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between AI tool results and genetic test results (time frame: Through study completion, an average at one year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2026.