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Clinical Trials in Italy / NCT07260188
Recruiting Observational

Organoids From Breast Cancer Patients Treated With Neoadjuvant Therapy

NCT07260188 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituti Clinici Scientifici Maugeri SpA
Phase
Observational
Started
2025-09-23
Last updated
2025-12-03

Condition(s) studied

Invasive Breast Cancer

Investigational drug(s) / intervention(s)

Blood and tumor tissue collection

Blood 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.

Study 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
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Istituti Clinici Scientifici Maugeri Pavia PV Recruiting

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Other trials for the same condition

Patient-Derived Breast Cancer Organoids for Therapeutic Extracellular Vesicle Isolation (PDO-Mercurial01) Active, not recruiting
Neoadjuvant Treatment of HER2 Positive Early High-risk and Locally Advanced Breast Cancer Active, not recruiting
fREEDOM: REsonance for Early Detection Of Breast Cancer Metastases Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07260188 on ClinicalTrials.gov ↗ ← All trials in Italy