drugset / Trial / NCT06102824
Organoid-based Functional Precision Therapy for Advanced Breast Cancer
Phase 2
Recruiting
252 enrolled
Guangdong Provincial People's Hospital
First Affiliated Hospital, Sun Yat-Sen University · collabShantou Central Hospital · collabSun Yat-sen University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a phase II, multicenter, open-label, randomized controlled trial to compare the efficacy of organoid-guided treatment (OGT) to treatment of physician's choice (TPC) in previously treated, HER2-negative locally advanced or metastatic breast cancer. The study will seek to provide evidence for utilizing patient-derived organoid (PDO) model to personalize treatment strategies and inform clinical care for advanced breast cancer. Subjects randomized to the OGT group will undergo PDO generation and receive treatment dictated by subsequent PDO drug sensitivity screening. Subjects randomized to the TPC group will receive empirical therapy as selected by the treating physician.
Timeline
- Start
- 2024-10-01
- Primary completion
- 2027-06-30
- Completion
- 2028-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Comparator | Capecitabine | Small molecule | 1250 mg/m2 | Oral |
| Comparator | Carboplatin | Small molecule | — | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 40 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Comparator | Epothilone D | Small molecule | 30 mg/m2 | Intravenous |
| Comparator | Eribulin | Small molecule | 1.4 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 800 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 1200 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 125 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 260 mg/m2 | Intravenous |
| Comparator | Sacituzumab Govitecan | Monoclonal antibody | 10 mg/kg | Intravenous |
| Comparator | Trastuzumab deruxtecan | Monoclonal antibody | 5.4 mg/kg | Intravenous |
| Comparator | Vinorelbine | Small molecule | 20 mg/m2 | Intravenous |
| Comparator | Vinorelbine | Small molecule | 35 mg/m2 | Intravenous |