Breast CancerMATADORNCT06219187
Male breAsT cAncer preDisposition Factor
An observational study of Breast Cancer, run by Institut Claudius Regaud at 1 site in France.
Trial summary
This is a non-interventional, prospective, single-center study designed to collect and describe environmental and psychosocial data from patients with a history of male breast cancer (MBC) referenced in the IUCT-O regional database. The study will be conducted on a population of 110 to 150 patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Questionnaire completion
- How many people
- 93 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2024to 6 Feb 2025
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a history of male breast cancer (MBC) referenced in the IUCT-O's regional MutaFamily-MBC database.
Who may be able to join
- Male patient with a personal history of breast cancer
- Age ≥ 18 years
- Patient who has had an oncogenetic consultation at IUCT-O and is registered in the IUCT-O oncogenetic database
- Patient for whom no pathogenic variant has been detected on the HBOC panel (HBOC-)
- Patient with no objection to participation in the trial (for deceased patients: trusted support person with no objection to participation).
Who cannot join
- 1. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Trial locations and contacts
1 site in 1 country.
About this study
This is a non-interventional, prospective, single-center study designed to collect and describe environmental and psychosocial data from patients with a history of male breast cancer (MBC) referenced in the IUCT-O regional database.
The study will be conducted on a population of 110 to 150 patients.
- Conditions
- Breast Cancer
- Being tested
- Questionnaire completion
- Keywords
- Breast Cancer, PreDisposition factor
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire completionOther
To meet the study's objective, patients will be asked to complete a questionnaire characterizing their environmental and psychosocial context.
The questionnaire is to be completed by the patients themselves, or by their trusted support person as recorded in their medical records (in the particular case of a deceased patient).
It is estimated that the questionnaire will take around 30 minutes to complete.
Data will also be collected from the medical records of included patients:
- Demographics
- Disease data
| Study group | Role | What they receive |
|---|---|---|
| Male breast cancer | Not described Receives: Other: Questionnaire completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The environmental data in the questionnaire will be described by the usual descriptive statistics.
A 75-question questionnaire will cover such aspects as the patient's living conditions, professional situation, qualifications or level of education, social environment, early life and family environment, general health and recent significant events.
Quantitative data will be described by the median, minimum, maximum and number of missing data, and qualitative data by the numbers, percentages and number of missing data for each modality.
Measured: 15 days for each patient
Psychosocial data from the questionnaire will be described using standard descriptive statistics.
A 75-question questionnaire will cover such aspects as the patient's living conditions, professional situation, qualifications or level of education, social environment, early life and family environment, general health and recent significant events.
Quantitative data will be described by the median, minimum, maximum and number of missing data, and qualitative data by the numbers, percentages and number of missing data for each modality.
Measured: 15 days for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start8 Feb 2024
- Primary completion6 Feb 2025
- Study completion6 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219187
- Sponsor's protocol ID
- 23 SEIN 02
- Acronym
- MATADOR
- Status last verified
- Feb 2025
- First submitted
- 12 Jan 2024
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Male breAsT cAncer preDisposition Factor
- ClinicalTrials.gov ID
- NCT06219187
- Acronym / sponsor ID
- MATADOR / 23 SEIN 02
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, PreDisposition factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 6 Feb 2025 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 23 Jan 2024 (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.
This is a non-interventional, prospective, single-center study designed to collect and describe environmental and psychosocial data from patients with a history of male breast cancer (MBC) referenced in the IUCT-O regional database.
The study will be conducted on a population of 110 to 150 patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Male breast cancer | – | Other: Questionnaire completion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a history of male breast cancer (MBC) referenced in the IUCT-O's regional MutaFamily-MBC database.
Key inclusion criteria (5 listed)
- Male patient with a personal history of breast cancer
- Age ≥ 18 years
- Patient who has had an oncogenetic consultation at IUCT-O and is registered in the IUCT-O oncogenetic database
- Patient for whom no pathogenic variant has been detected on the HBOC panel (HBOC-)
- Patient with no objection to participation in the trial (for deceased patients: trusted support person with no objection to participation).
Key exclusion criteria (1 listed)
- 1. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire completionTo meet the study's objective, patients will be asked to complete a questionnaire characterizing their environmental and psychosocial context. The questionnaire is to be completed by the patients themselves, or by their trusted support person as recorded in their medical records (in the particular case of a deceased patient). It is estimated that the questionnaire will take around 30 minutes to complete. Data will also be collected from the medical records of included patients: * Demographics * Disease data | Other | Male breast cancer |
Primary outcome
The environmental data in the questionnaire will be described by the usual descriptive statistics.
Time frame: 15 days for each patient
A 75-question questionnaire will cover such aspects as the patient's living conditions, professional situation, qualifications or level of education, social environment, early life and family environment, general health and recent significant events. Quantitative data will be described by the median, minimum, maximum and number of missing data, and qualitative data by the numbers, percentages and number of missing data for each modality.
Psychosocial data from the questionnaire will be described using standard descriptive statistics.
Time frame: 15 days for each patient
A 75-question questionnaire will cover such aspects as the patient's living conditions, professional situation, qualifications or level of education, social environment, early life and family environment, general health and recent significant events. Quantitative data will be described by the median, minimum, maximum and number of missing data, and qualitative data by the numbers, percentages and number of missing data for each modality.
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 10 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cancer, run by Institut Claudius Regaud at 1 site in France.
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 10 Jun 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 France. 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?
The environmental data in the questionnaire will be described by the usual descriptive statistics. (time frame: 15 days for each patient). The study lists 2 primary outcomes in all. 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 10 Jun 2026.