Organoids From Breast Cancer Patients Treated With Neoadjuvant Therapy

NCT07260188 | Recruiting

• 1 other identifier: 36713
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Invasive Breast Cancer

Keywords

Triple Negative Breast Cancer; Neadjuvant Chemotherapy; Patient-Derived Organoids; Liquid Biopsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Predictive model of treatment response

  36 months

Interventions

Blood and tumor tissue collection PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Istituti Clinici Scientifici Maugeri

Pavia, PV, 27100, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue, plasma, organoids

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Fabio CorsI

CONTACT

+390382592272; fabio.corsi@icsmaugeri.it

Marta Truffi

CONTACT

+390382592219; marta.truffi@icsmaugeri.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 3, 2025
• Study Start: September 23, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

IT (1)