Organoids From Breast Cancer Patients Treated With Neoadjuvant Therapy (PDO-Neo01)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Invasive Breast Cancer
• Intervention / Treatment: Procedure: Blood and tumor tissue collection

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).

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Fabio Corsi; Phone Number: +390382592272; Email: fabio.corsi@icsmaugeri.it
• Study Contact Backup: Name: Marta Truffi; Phone Number: +390382592219; Email: marta.truffi@icsmaugeri.it

Study Locations

• Italy
  • PV
    • Pavia, PV, Italy, 27100
      • Recruiting
      • Istituti Clinici Scientifici Maugeri
      • Contact: Fabio Corsi; Phone Number: +390382592272; Email: fabio.corsi@icsmaugeri.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All patients consecutively referred to the Breast Unit of the IRCCS ICS Maugeri in Pavia and the Oncology Department of Sacco Hospital in Milan, who have breast neoplasm with an indication for neoadjuvant chemotherapy, will be included in the study.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establishment of Patient-Derived Organoids of Breast Cancer	Number and proportion of patients from which patient-derived organoid lines will be successfully established from collected tumor tissue samples.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive model of treatment response	Characterization of tumor-derived EVs in PDO conditioned medium (through biophysical, biochemical, spectroscopic, proteomic, genomic analyses) and evaluation of the difference of their features in patients achieving pCR compared to patients who do not achieve pCR	36 months

Collaborators and Investigators

• Sponsor: Istituti Clinici Scientifici Maugeri SpA
• Collaborators: ASST Fatebenefratelli Sacco; Università degli Studi di Brescia; Buzzi Children's Hospital; The National Research Council, Italy

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 28, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 28, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Triple Negative Breast Cancer; Liquid Biopsy; Patient-Derived Organoids; Neadjuvant Chemotherapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Skin and Connective Tissue Diseases; Triple Negative Breast Neoplasms; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: 36713