drugset / Trial / NCT06385990
Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy
NaSingle-groupOpen-labelTreatment
Summary
This trial is a multicenter, single-arm clinical trial to evaluate the efficacy and safety of UTD1 in combination with capecitabine for the adjuvant treatment of TNBC patients who did not achieve pathologic complete remission after neoadjuvant therapy. TNBC patients who did not achieve pathological complete remission or positive lymph node after neoadjuvant chemotherapy received adjuvant treatment with study drug. Solution: UTD1 30mg / m², once a day on days 1-5; capecitabine: 1000mg / m², days 1-14, oral, twice / day; 21 days a treatment cycle of 6-8 cycles.
Timeline
- Start
- 2024-03-29
- Primary completion
- 2025-03-29
- Completion
- 2027-03-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Epothilone D | Small molecule | 30 mg/m2 | — |
| Background | Capecitabine | Small molecule | 1000 mg/m2 | Oral |