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
Istituti Clinici Scientifici Maugeri SpA
240 participants
Sep 23, 2025
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
Inclusion Criteria7
- 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 Criteria3
- 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.
Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT07260188