Organoids From Breast Cancer Patients Treated With Neoadjuvant Therapy
Recruiting · NCT07260188 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- Istituti Clinici Scientifici Maugeri - Pavia, PV, Italy