Clinical trial · Observational
Patient-Derived Organoids to Functionally Characterize Chemotherapy Resistance in Breast Cancer
Functional Characterization of Neoadjuvant Chemotherapy Resistance in Breast Cancer Using Patient-Derived Organoid Models and Development of Drug Repurposing Strategies With Next-Generation Small Molecules
- 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)
This prospective observational study aims to functionally characterize chemotherapy resistance in patients with locally advanced breast cancer undergoing neoadjuvant chemotherapy. Despite standard molecular classification, significant heterogeneity in treatment response exists, and the biological mechanisms underlying chemoresistance remain incompletely understood. In this study, patient-derived organoid (PDO) models will be established from tumor tissues obtained during routine clinical care. These three-dimensional models preserve the biological characteristics of individual tumors and enable ex vivo functional assessment of drug response. Chemotherapy sensitivity and resistance will be evaluated using quantitative parameters including Half-Maximal Inhibitory Concentration (IC50) values, cell viability, and apoptotic response. Functional data obtained from PDO models will be correlated with clinical and pathological treatment outcomes, particularly pathological complete response (pCR), to assess the predictive value of PDO-based assays. In addition, apoptotic biomarkers such as Caspase-3/7 will be measured in serum samples collected during routine clinical evaluation and analyzed in relation to treatment response. Furthermore, selected Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved small molecules will be tested in PDO models to evaluate their potential to reverse chemotherapy resistance, supporting drug repurposing strategies. This study aims to establish a functional, patient-specific platform for assessing chemoresistance and to contribute to the development of personalized therapeutic approaches in breast cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Locally Advanced Breast Cancer (LABC) | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Locally Advanced Breast Cancer Patients Cohort
- description
- Adult female patients diagnosed with locally advanced breast cancer and scheduled to receive standard neoadjuvant chemotherapy. Tumor tissue and blood samples obtained during routine clinical care will be used to generate patient-derived organoid models and to perform biomarker analyses. No experimental intervention will be applied to participants.
Primary outcomes (1)
- measure
- Correlation Between PDO-Based Chemotherapy Response Metrics and Pathological Complete Response (pCR)
- timeFrame
- At completion of neoadjuvant chemotherapy (approximately 6 months)
- description
- Assessment of the association between functional drug response parameters obtained from patient-derived organoid (PDO) models (including Half-Maximal Inhibitory Concentration (IC50) values, cell viability, and apoptotic response) and pathological complete response (pCR) following neoadjuvant chemotherapy.
Secondary outcomes (4)
- measure
- Association Between PDO-Derived Drug Sensitivity Metrics and Clinical Chemotherapy Resistance
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients aged 18 years or older * Histologically confirmed locally advanced breast cancer * Planned to receive neoadjuvant chemotherapy * Availability of tumor tissue obtained during routine diagnostic or therapeutic procedures * Availability of clinical and pathological treatment data * Ability to provide written informed consent Exclusion Criteria: * Age under 18 years * Metastatic breast cancer * Prior systemic chemotherapy or targeted therapy for the current diagnosis * Presence of another active malignancy * Severe comorbid conditions that may interfere with study participation * Insufficient biological sample for organoid generation or analysis * Inability or unwillingness to provide informed consent
References
Publications (0)
Data not yet available