Clinical trial Recruiting at 1 site Observational Ages 18 to 70

Characterizing breast cancer subtypes using patient-derived organoids

Official title: Breast Cancer Subtype Characterization Through Patient's Derived Organoids". (BCinsightPDO)

Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06315868 · Data updated 2026-11-12

This study is testing if lab-grown mini-tumors from breast cancer patients can help doctors figure out which chemotherapy works best for people with triple-negative breast cancer or those whose cancer has come back.

Quick facts

Study typeObservational
Ages18 Years to 70 Years
SexAll
Enrollment306 (estimated)
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Roma)
StatusRecruiting
StartedJune 15, 2023
Main results expectedJune 15, 2026
Study endsJune 15, 2027
Registry record updatedMarch 18, 2024
Trial IDNCT06315868 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are women aged 18 to 70 diagnosed with primary breast cancer eligible for surgical resection.

Probably not a fit

Patients diagnosed with breast cancer during pregnancy or those who have received neoadjuvant chemotherapy 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 study focuses on developing tools to predict chemotherapy sensitivity in breast cancer patients, particularly those with triple-negative breast cancer or those experiencing relapse. By utilizing patient-derived organoids (PDO), which are 3D cultures that maintain the characteristics of primary tumors, the study aims to evaluate patient-specific responses to treatments. PDOs allow for pharmacological testing and genetic manipulation in a setting that closely mimics the human body, providing a platform for personalized therapy development. The goal is to create a stable collection of PDOs that represent the diversity of breast cancer subtypes, aiding in the understanding of chemoresistance and treatment efficacy.

Why it matters

Potential benefit: If successful, this approach could lead to more personalized and effective treatment options for breast cancer patients.

How similar studies have gone: Other studies have shown promise in using patient-derived organoids for personalized cancer treatment, indicating a potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* women diagnosed with primary BC, eligible for surgical resection of the tumor according to national and international guidelines.

age between 18 and 70 years; newly diagnosed breast neoplasms, tumor size of at least 1.5 cm diameter.

Exclusion Criteria:

breast cancer diagnosed during pregnancy, neoadiuvant chemotherapy

Where it's running

  • IRCCS Fondazione Policlinico A. Gemelli
    Roma, 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.