Male Breast CancerMATADOR2NCT07558343
Male breAsT cAncer preDisposition Factor: Creation of a Control Cohort 2
A study testing Questionnaire completion and Genetic analysis (WES) in people with Male Breast Cancer, run by Institut Claudius Regaud at 1 site in France.
Trial summary
This is an interventional, prospective, single-center study designed to collect and describe genetic, environmental and psychosocial control data from male participants. The participants did not have any prior history of cancer at the time of the oncogenetic consultation and do not have the family mutation researched… Read more about this study
- Who is it for?
- Ages 66 years and older, men only
- Conditions the study is for
- Male Breast Cancer
- What is being tested?
- Questionnaire completion and Genetic analysis (WES)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2026to 15 Oct 2027
- Phase
- Interventional
- 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 66 years and older
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- 1. A male volunteer participant with no personal history of cancer, registered in the IUCT-O oncogenetics database as a relative of a patient carrying a pathogenic or likely pathogenic variant in one of the cancer predisposition genes routinely analyzed at the oncogenetics laboratory
- 2. Age ≥ 66 years
- 3. Participant with no known family relationship to a patient of the MATADOR1 cohort
- 4. Participant who has undergone an oncogenetic consultation at the IUCT-O
- 5. Participant who does not carry the familial mutation in any of the cancer predisposition genes previously tested
- 6. Participant for which an archived blood sample is available for the research in the oncogenetics laboratory
- 7. Participant having signed an informed consent form before inclusion in the study and before any study specific procedure
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. Contact the study team or a site near you to ask about taking part.
France1 site
Institut Universitaire du Cancer Toulouse - Oncopole, Laboratoire d'oncogénétique
Toulouse, 31059
Ayman AL SAATI, PharmD, PhD, 0033 5 31 15 52 20, alsaati.ayman@iuct-oncopole.fr
About this study
This is an interventional, prospective, single-center study designed to collect and describe genetic, environmental and psychosocial control data from male participants. The participants did not have any prior history of cancer at the time of the oncogenetic consultation and do not have the family mutation researched during the oncogenetic consultation (targeted genetic testing). The participants are referenced in the IUCT-O medical records as family members of patients suffering from male breast cancer.
The study will be conducted on a population of 120 participants.
- Conditions
- Male Breast Cancer
- Being tested
- Questionnaire completion, Genetic analysis (WES)
- Keywords
- breast cancer, predisposition factor
- Medical subject headings
- Breast Neoplasms, Male, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire completionOther
In order to meet the study's objective, after written informed consent was obtained, participants will be asked to complete a questionnaire characterizing their environmental and psychosocial context. The questionnaire is to be filled out by the participants at home. It is estimated that the questionnaire will take around 30 minutes to complete.
Demographics data will also be collected from the medical records of included participants.
Genetic analysis (WES)Other
In order to meet the study's objective, after completion of the questionnaire, a genetic analysis (Whole Exome Sequencing) will be conducted on an archived blood sample collected during the initial oncogenetics consultation. The patient had given consent to this sample in order for the oncogenetics laboratory to perform the targeted genetic analysis (presence of family mutation). No additional blood sample will be collected for the purpose of this study.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | The participants enrolled in this study (MATADOR2) will serve as control group for the patients enrolled in the previous study (MATADOR = MATADOR1) in order to identify:
1. the environmental and psychosocial predisposition factors
2. the genetic predisposition factors Receives: Other: Questionnaire completion; Other: Genetic analysis (WES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The environmental and psychosocial data in the questionnaire will be described by the usual descriptive statistics.
A 75-question questionnaire (created for the purposes of the MATADOR project) will cover such aspects as the participant's living conditions, professional situation, qualifications or level of education, social environment, early life and family environment, general health and recent significant events. For each question of the questionnaire: quantitative variables will be described by the median, minimum, maximum and number of missing data, and qualitative variables by the numbers, percentages and number of missing data.
Measured: 30 days approximately for each participant, 1 year and 1 month in total for all patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Oct 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is intended to serve as a control group for the MATADOR study (=MATADOR1) which was conducted on patients presenting with male breast cancer (MBC). Their environmental and psychosocial background was studied through the completion of a questionnaire. In this study (MATADOR2), the participants were free of cancer at the time of the oncogentic consultation and did not present the family mutation (on the MBC predisposition genes routinely tested in oncogenetic consultation). In this control group, the participants will complete the same questionnaire as the MATADOR1 patients. In addition, the genetic predisposition factors will be analyzed through genetic analysis (Whole Exome Sequencing).
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
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
- NCT07558343
- Sponsor's protocol ID
- 26 SEIN 02
- Acronym
- MATADOR2
- Status last verified
- Aug 2026
- First submitted
- 16 Apr 2026
- Last updated
- 19 Aug 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 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Male breAsT cAncer preDisposition Factor: Creation of a Control Cohort 2
- ClinicalTrials.gov ID
- NCT07558343
- Acronym / sponsor ID
- MATADOR2 / 26 SEIN 02
- Conditions
- Male Breast Cancer
- Keywords
- breast cancer, predisposition factor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 30 Apr 2026 (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 an interventional, prospective, single-center study designed to collect and describe genetic, environmental and psychosocial control data from male participants. The participants did not have any prior history of cancer at the time of the oncogenetic consultation and do not have the family mutation researched during the oncogenetic consultation (targeted genetic testing). The participants are referenced in the IUCT-O medical records as family members of patients suffering from male breast cancer.
The study will be conducted on a population of 120 participants.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is intended to serve as a control group for the MATADOR study (=MATADOR1) which was conducted on patients presenting with male breast cancer (MBC). Their environmental and psychosocial background was studied through the completion of a questionnaire. In this study (MATADOR2), the participants were free of cancer at the time of the oncogentic consultation and did not present the family mutation (on the MBC predisposition genes routinely tested in oncogenetic consultation). In this control group, the participants will complete the same questionnaire as the MATADOR1 patients. In addition, the genetic predisposition factors will be analyzed through genetic analysis (Whole Exome Sequencing).
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Questionnaire completion, Other: Genetic analysis (WES)The participants enrolled in this study (MATADOR2) will serve as control group for the patients enrolled in the previous study (MATADOR = MATADOR1) in order to identify: 1. the environmental and psychosocial predisposition factors 2. the genetic predisposition factors |
Who may qualify
- Ages
- 66 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 1. A male volunteer participant with no personal history of cancer, registered in the IUCT-O oncogenetics database as a relative of a patient carrying a pathogenic or likely pathogenic variant in one of the cancer predisposition genes routinely analyzed at the oncogenetics laboratory
- 2. Age ≥ 66 years
- 3. Participant with no known family relationship to a patient of the MATADOR1 cohort
- 4. Participant who has undergone an oncogenetic consultation at the IUCT-O
- 5. Participant who does not carry the familial mutation in any of the cancer predisposition genes previously tested
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 completionIn order to meet the study's objective, after written informed consent was obtained, participants will be asked to complete a questionnaire characterizing their environmental and psychosocial context. The questionnaire is to be filled out by the participants at home. It is estimated that the questionnaire will take around 30 minutes to complete. Demographics data will also be collected from the medical records of included participants. | Other | Control group |
| Genetic analysis (WES)In order to meet the study's objective, after completion of the questionnaire, a genetic analysis (Whole Exome Sequencing) will be conducted on an archived blood sample collected during the initial oncogenetics consultation. The patient had given consent to this sample in order for the oncogenetics laboratory to perform the targeted genetic analysis (presence of family mutation). No additional blood sample will be collected for the purpose of this study. | Other | Control group |
Primary outcome
The environmental and psychosocial data in the questionnaire will be described by the usual descriptive statistics.
Time frame: 30 days approximately for each participant, 1 year and 1 month in total for all patients
A 75-question questionnaire (created for the purposes of the MATADOR project) will cover such aspects as the participant's living conditions, professional situation, qualifications or level of education, social environment, early life and family environment, general health and recent significant events. For each question of the questionnaire: quantitative variables will be described by the median, minimum, maximum and number of missing data, and qualitative variables by the numbers, percentages and number of missing data.
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 19 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire completion and Genetic analysis (WES) in people with Male 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 7 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: opening soon, as of the sponsor's last update on 19 Aug 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?
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 Ayman AL SAATI, PharmD, PhD (0033 5 31 15 52 42, alsaati.ayman@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The environmental and psychosocial data in the questionnaire will be described by the usual descriptive statistics. (time frame: 30 days approximately for each participant, 1 year and 1 month in total for all patients). 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 19 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.