Making organoids from breast tumors before and after neoadjuvant chemotherapy
Prospective Multicenter Study on the Collection of Tumor Biopsies and the Generation of Organoids Derived From Breast Cancer Patients Scheduled for Neoadjuvant Chemotherapy
This project will test whether lab-grown mini-tumors (patient-derived organoids) and blood biomarkers can help predict who will have a complete response to neoadjuvant chemotherapy for invasive breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Pavia, PV) |
| Trial ID | NCT07260188 on ClinicalTrials.gov |
What this trial studies
This observational study enrolls people with invasive breast cancer who are scheduled for neoadjuvant chemotherapy and surgery. Tumor tissue will be collected before and after treatment to create patient-derived organoid (PDO) cultures that model each patient's tumor. Researchers will analyze biomarkers released by the organoids, especially those carried in extracellular vesicles, and compare them with tumor tissue and blood samples collected before, during, and after therapy. Biomarker patterns will be correlated with pathological complete response versus residual disease to identify potential predictors of treatment outcome.
Who should consider this trial
Good fit: Female patients with confirmed invasive breast cancer who are planned to receive neoadjuvant chemotherapy and are willing to provide tumor biopsies and blood samples for research.
Not a fit: Patients who have already received prior chemotherapy, those without a confirmed cyto-histological diagnosis of breast carcinoma, or those with other active solid tumors are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could help predict which patients will achieve a complete response to neoadjuvant chemotherapy and guide more personalized treatment decisions.
How similar studies have performed: Related work using patient-derived organoids and liquid biopsy markers in cancer has produced promising early results but remains experimental and not yet standard clinical practice.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female subjects; * Confirmed diagnosis of breast heteroplasia * Age 1\>= 8 years; * Indication for neoadjuvant chemotherapy; * Patients willing to follow the usual oncological follow-up; * Patients with de novo metastatic disease (M+), receiving primary chemotherapy, if candidates for primary tumor biopsy; * Subjects who agree to participate in the study by signing and dating the Informed Consent form. Exclusion Criteria: * Patients who have already undergone prior chemotherapy treatments; * Patients without a proven cyto-histological diagnosis of breast carcinoma; * Subjects affected by other solid tumors besides the breast lesion.
Where this trial is running
Pavia, PV
- Istituti Clinici Scientifici Maugeri — Pavia, Pv, Italy (Recruiting)
Study contacts
- Study coordinator: Fabio CorsI
- Email: fabio.corsi@icsmaugeri.it
- Phone: +390382592272
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.