drugset / Trial / NCT06519370
FDA018-ADC vs Investigator's Choice Chemotherapy to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase III, randomized, open-label, 2-arm, multicentre, international study assessing the efficacy and safety of FDA018-ADC compared with Investigator's Choice Chemotherapy(ICC) in participants with locally recurrent inoperable or metastatic Triple-negative Breast Cancer(TNBC) who are resistant to, or recurring during or after taxane therapy.
Timeline
- Start
- 2024-08-09
- Primary completion
- 2026-08-18
- Completion
- 2027-06-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Comparator | Capecitabine | Small molecule | 1250 mg/m2 | Oral |
| Comparator | Eribulin | Small molecule | 1.4 mg/m2 | Intravenous |
| Subject | FDA018-ADC | Unknown | 10 mg/kg | Intravenous |
| Comparator | Gemcitabine | Small molecule | 800 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 1200 mg/m2 | Intravenous |
| Comparator | Vinorelbine | Small molecule | 25 mg/m2 | Intravenous |