Clinical trial · Observational
Organoids From Breast Cancer Patients Treated With Neoadjuvant Therapy
Prospective Multicenter Study on the Collection of Tumor Biopsies and the Generation of Organoids Derived From Breast Cancer Patients Scheduled for Neoadjuvant Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood and tumor tissue collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Establishment of Patient-Derived Organoids of Breast Cancer
- timeFrame
- 36 months
- description
- Number and proportion of patients from which patient-derived organoid lines will be successfully established from collected tumor tissue samples.
Secondary outcomes (1)
- measure
- Predictive model of treatment response
- timeFrame
- 36 months
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available