Organoids From Breast Cancer Patients Treated With Neoadjuvant Therapy

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.

NCT Number	NCT07260188
Lead Sponsor	Istituti Clinici Scientifici Maugeri SpA Collaborators: ASST Fatebenefratelli Sacco, Università degli Studi di Brescia, Buzzi Children's Hospital, The National Research Council, Italy
Conditions	Invasive Breast Cancer
Enrollment	240 participants
Start Date	2025-09-23
Primary Completion	2028-07 (estimated)
Study Completion	2028-07 (estimated)
Updated on ClinicalTrials.gov	2025-12-03