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

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.

Trial Details

NCT ID
NCT06385990
Phase
PHASE2
Sponsor
Hunan Cancer Hospital
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • UTD1
Locations (sample)
  • Changsha, Hunan, China|28.19874,112.97087

Key Eligibility Criteria

  • Signed informed consent;
  • 18 Years and older;
  • Breast cancer confirmed by pathological histology, ER-negative (\<1% positive), PR-negative (\<1% positive), and HER2-negative (IHC: HER2 (0), HER2…
  • Patients must receive full course of neoadjuvant chemotherapy before surgery and did not achieve pathological complete response (i. e., pathologica…

For full eligibility, visit ClinicalTrials.gov.

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