Characterizing breast cancer subtypes using patient-derived organoids
Breast Cancer Subtype Characterization Through Patient's Derived Organoids". (BCinsightPDO)
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 |
|---|---|
| Enrollment | 306 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Roma) |
| Trial ID | NCT06315868 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 70 diagnosed with primary breast cancer eligible for surgical resection.
Not a fit: Patients diagnosed with breast cancer during pregnancy or those who have received neoadjuvant chemotherapy may not benefit from this study.
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 performed: Other studies have shown promise in using patient-derived organoids for personalized cancer treatment, indicating a potential for success in this approach.
Eligibility criteria
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 this trial is running
Roma
- IRCCS Fondazione Policlinico A. Gemelli — Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Alba Di Leone, Doc
- Email: alba.dileone@policlinicogemelli.it
- Phone: 0039 3474980503
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.