Clinical trial Recruiting at 1 site Observational Ages 18 and up Men only

Creating organoid cultures from male breast tumors

Official title: Feasibility Study for the Generation of Organoids From Male Breast Tumors

Run by Regina Elena Cancer Institute · NCT06786663 · Data updated 2026-11-12

This study is trying to grow mini versions of male breast tumors from patients to see how well they match the original tumors and how they respond to treatments.

More Breast Neoplasms, Male trials

Quick facts

Study typeObservational
Ages18 Years and up
SexMen only
Enrollment7 (estimated)
SponsorRegina Elena Cancer Institute
Academic / other
Locations1 site (Rome)
StatusRecruiting
StartedApril 19, 2024
Main results expectedApril 19, 2027
Study endsApril 19, 2027
Registry record updatedJanuary 22, 2025
Trial IDNCT06786663 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include men over 18 years with histologically confirmed breast cancer who are scheduled for surgical intervention.

Probably not a fit

Patients without adequate biological material for analysis or those not undergoing surgery may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to establish organoid cultures derived from male breast cancer patients who have undergone surgery. The project will generate at least five organoid cultures to assess their success rate and verify their correspondence with the original tumor tissue. Comprehensive molecular investigations, including DNA mutational analysis, RNA sequencing, and proteomic studies, will be conducted to understand the underlying mechanisms of the tumor. Additionally, in vitro viability tests will evaluate the organoids' response to the same treatments given to the patients.

Why it matters

Potential benefit: If successful, this study could lead to personalized therapeutic strategies for male breast cancer patients.

How similar studies have gone: While organoid technology is gaining traction, this specific focus on male breast cancer is relatively novel and has not been extensively tested in prior studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Men aged \>18 years
* Patients with histologically confirmed breast cancer with or without synchronous metastases, who will undergo the relevant surgical intervention
* Adequate biological material to be able to carry out the analyses described above
* Signing of the relevant informed consent form

Exclusion Criteria:

not present

Where it's running

  • IRCCS National Cancer Institute "Regina Elena"
    Rome, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.