Patient-Derived Organoids to Functionally Characterize Chemotherapy Resistance in Breast Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorAtlas University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age under 18 years
Metastatic breast cancer
Prior systemic chemotherapy or targeted therapy for the current diagnosis
Presence of another active malignancy
Trial population
Adult female patients diagnosed with locally advanced breast cancer and scheduled to receive neoadjuvant chemotherapy at a tertiary academic center. All participants will be recruited prospectively and followed during the course of standard clinical treatment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
40 Participants
are grouped into 1 trial groupGroup A: Locally Advanced Breast Cancer Patients Cohort
Trial outcomes
Primary outcomes
1
Correlation Between PDO-Based Chemotherapy Response Metrics and Pathological Complete Response (pCR)
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.
Time frame
At completion of neoadjuvant chemotherapy (approximately 6 months)Secondary outcomes
1
Association Between PDO-Derived Drug Sensitivity Metrics and Clinical Chemotherapy Resistance
Evaluation of chemotherapy resistance phenotypes in patient-derived organoid (PDO) models using quantitative measures such as Half-Maximal Inhibitory Concentration (IC50), cell viability, and apoptotic response, and their relationship with clinical treatment outcomes.
Time frame
At baseline (prior to initiation of neoadjuvant chemotherapy) and at completion of treatment (approximately 6 months)2
Serum Apoptotic Biomarkers and Their Association With Treatment Response
Analysis of serum apoptotic biomarkers, including Caspase-3/7 levels, and their correlation with pathological treatment response and chemotherapy resistance.
Time frame
At baseline, during neoadjuvant chemotherapy, and at completion of treatment (approximately 6 months)3
Evaluation of Drug Repurposing Strategies in PDO Models
Assessment of the effects of selected Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved small molecules on chemotherapy-resistant patient-derived organoid (PDO) models to evaluate their potential to reverse resistance.
Time frame
Within 6 months after sample collection4
Development of Functional Predictive Models for Chemotherapy Response
Integration of PDO-derived functional data and clinical parameters to develop predictive models for treatment response in breast cancer patients.
Time frame
Within 12 months after completion of data collectionSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: