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 type | Observational |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 306 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | June 15, 2023 |
| Main results expected | June 15, 2026 |
| Study ends | June 15, 2027 |
| Registry record updated | March 18, 2024 |
| Trial ID | NCT06315868 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
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IRCCS Fondazione Policlinico A. Gemelli
Roma, Italy Recruiting
Study contacts
- Study coordinator: Alba Di Leone, Doc
- Email: alba.dileone@policlinicogemelli.it
- Phone: 0039 3474980503
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.