Clinical trial · Observational
Drug Sensitivity of Hydrothorax and Ascite Organoids from Breast Cancer
Drug Sensitivity Based on Hydrothorax and Ascite Organoids Derived from Metastasic Breast Cancer
- 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)
Malignant hydrothorax and ascitic fluid in advanced breast cancer often arise from metastasis to the lungs, pleura, or liver. Patients with this condition experience rapid disease progression and multidrug resistance, facing limited treatment options. Clinical guidelines offer various therapies based on molecular subtypes; however, their effectiveness can be hindered by prior treatments, patient health, and tumor evolution. Current evaluations of treatment efficacy typically take two cycles, delaying the recognition of ineffective therapies and resulting in unnecessary side effects and costs. Organoid models present a promising solution, accurately replicating tumor structure and cellular diversity compared to traditional methods. These patient-derived models facilitate improved drug sensitivity testing, leading to more personalized treatment plans. In this study, 90 patients diagnosed with metastatic breast cancer accompanied by hydrothorax and ascitic fluid will be recruited. Patient-derived organoids will be used to assess the sensitivity of chemotherapy regimens, including Doxorubicin, Carboplatin, Cyclophosphamide, and Paclitaxel, along with targeted therapies such as Herceptin and Pertuzumab.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ascites | — | UNRESOLVED | — |
| Breast Cancer Metastatic | — | UNRESOLVED | — |
| Drug Evaluation | — | UNRESOLVED | — |
| Hydrothorax | — | UNRESOLVED | — |
| Organoids | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| organoid drug test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Correlation between drug sensitivity test results in patient-derived organoid models and clinical outcomes. The drug sensitivity test results obtained from patient-derived organoid models will be compared with the clinical outcomes.
- timeFrame
- 2024.10-2026.10
Secondary outcomes (1)
- measure
- The sensitivity and specificity would be checked between drug sensitivity of organoid models in predicting the efficacy of treatment.
- timeFrame
- 2024.10-2026.10
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed informed consent form and willingness to participate in the clinical study. 2. patients aged between 18 and 70 years old. 3. Confirmed metastatic breast cancer patients with hydrothorax and ascite fluid, which was verified to contain tumor cells by lab. 4. ECOG performance status score of 0-1. 5. No significant abnormalities in liver and kidney function (BIL \<1.5-fold upper limit of normal (ULN);ALT\<2.5×ULN; AST\<2.5×ULN;Crea≤1×ULN). Exclusion Criteria: 1.Patients not suitable for chemotherapy and target therapy
References
Publications (0)
Data not yet available