RecruitingNCT07260188

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


Sponsor

Istituti Clinici Scientifici Maugeri SpA

Enrollment

240 participants

Start Date

Sep 23, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting tumor samples from breast cancer patients who are receiving chemotherapy before surgery (called neoadjuvant chemotherapy) to grow miniature tumor models called organoids — which could help predict how well treatments will work. **You may be eligible if...** - You are female and 18 years or older - You have a confirmed diagnosis of breast cancer - You are scheduled to receive chemotherapy before surgery - You agree to standard oncological follow-up care **You may NOT be eligible if...** - You have already received prior chemotherapy for this diagnosis - You are unable or unwilling to sign the informed consent - You do not meet other study health criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBlood 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.


Locations(1)

Istituti Clinici Scientifici Maugeri

Pavia, PV, Italy

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NCT07260188


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