Organoids From Breast Cancer Patients Treated With Neoadjuvant Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood and tumor tissue collection.
- Who it may be relevant to
- Registry conditions: Invasive Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Multicenter Study on the Collection of Tumor Biopsies and the Generation of Organoids Derived From Breast Cancer Patients Scheduled for Neoadjuvant Chemotherapy
Overview
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.
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).
Interventions
- Procedure 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 wil
Primary outcome measures
- Establishment of Patient-Derived Organoids of Breast Cancer [Time frame: 36 months]
Secondary outcome measures (1)
- Predictive model of treatment response [Time frame: 36 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Istituti Clinici Scientifici Maugeri — Pavia
Identifiers
NCT: NCT07260188 · 36713