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Organoids From Breast Cancer Patients Treated With Neoadjuvant Therapy

ConditionInvasive Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorIstituti Clinici Scientifici Maugeri SpA

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Female subjects;

Confirmed diagnosis of breast heteroplasia

Age 1>= 8 years;

Indication for neoadjuvant chemotherapy;

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood and tumor tissue collection

    Procedure/Surgery

    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.

Treatment groups

No treatment groups listed

Trial outcomes

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.

Time frame
36 months

Secondary outcomes

1

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

Time frame
36 months

Other outcomes

Sponsors and contacts

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Istituti Clinici Scientifici Maugeri SpA

Lead sponsor

ASST Fatebenefratelli Sacco

Collaborator

Università degli Studi di Brescia

Collaborator

Buzzi Children's Hospital

Collaborator

The National Research Council, Italy

Collaborator

Source ClinicalTrials.gov
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