NCT07260188

Organoids From Breast Cancer Patients Treated With Neoadjuvant Therapy

Prospective Multicenter Study on the Collection of Tumor Biopsies and the Generation of Organoids Derived From Breast Cancer Patients Scheduled for Neoadjuvant Chemotherapy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 240 (estimated)
• Sponsor: Istituti Clinici Scientifici Maugeri SpA · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: —

Summary

The aim of this study is to establish patient-derived organoid (PDO) and tumor tissue cultures from breast cancer patients, in order to create personalized, accurate, and reliable preclinical models capable of providing information on the diverse biomolecular portraits of breast cancer. These models may also be used to predict the achievement of pathological complete response after neoadjuvant chemotherapy (NAC) treatment, study the biological, molecular, genetic, and microenvironmental characteristics of each tumor, and isolate tumor-derived extracellular vesicles from the PDOs and tissues and analyze them as potential biomarkers of response to NAC.

Detailed description

This study will recruit patients diagnosed with breast cancer who are candidates for neoadjuvant chemotherapy and subsequent surgery. Tumor tissue samples will be collected before and after treatment to establish patient-derived organoid cultures, which serve as personalized models of each patient's real tumor. Biomarkers released by the organoids (in particular those transported by extracellular vescicles) will be analyzed to identify predictors of therapeutic response. These biomarkers will be correlated with their expression in tumor tissue and subsequently validated in blood samples, collected pre, during and post treatment, as a non-invasive liquid biopsy approach. All data obtained will be analyzed by comparing patients who achieve a pathological complete response (pCR) with those who present residual disease after therapy (non-pCR).

Conditions

• Invasive Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Blood and tumor tissue collection	This prospective multicenter and observational study aims to recruit breast cancer patients scheduled for neoadjuvant chemotherapy (NAC). After obtaining informed consent, detailed clinical and anamnestic data will be collected, including tumor type and size, TNM stage, and biomolecular profile. During the clip placement procedure, which is performed before NAC to locate the lesion site, two tissue biopsies will be collected, processed, and used for PDO and tissue culture. The pre-NAC biopsy will utilize the clip needle, avoiding any additional discomfort. In cases of incomplete clinical response to NAC, a sample of residual neoplasia will also be collected from the surgical specimen after the operation, following the sampling for appropriate histopathological analyses. For each patient participating in the study, a blood sample is also planned to be collected at the following timepoints: T0, before the start of NAC; T1, mid-therapy; and T2, at the end of therapy before surgery.

Timeline

• Start date: 2025-09-23
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2025-12-03
• Last updated: 2025-12-03

Locations

1 site across 1 country: Italy