drugset / Trial / NCT06385990

Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy

NCT06385990

Phase 2 Recruiting 53 enrolled Hunan Cancer Hospital
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

EvaluationDrugModalityDoseRoute
Subject Epothilone D Small molecule 30 mg/m2
Background Capecitabine Small molecule 1000 mg/m2 Oral