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Comparing UTD2 Combined With Capecitabine to Capecitabine as Adjuvant Therapy for Non-pCR TNBC Patients

NCT07021261 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2025-06-13

No results posted yet for this study

Summary

Evaluate the IDFS rate, overall survival (OS) rate, and safety profile of UTD2 combined with capecitabine versus capecitabine monotherapy as adjuvant therapy for triple-negative early breast cancer patients who did not achieve pathological complete response (pCR) after neoadjuvant therapy.

Conditions

Interventions

DRUG

Utidelone plus capecitabine

UTD2 50 mg/m²/day orally on Days 1-5, repeated every 21 days for 2 years; Capecitabine 1000 mg/m² twice daily on Days 1-14, repeated every 21 days for 8 cycles.

DRUG

Capecitabine

Capecitabine 1000 mg/m² twice daily on Days 1-14, repeated every 21 days for 8 cycles.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-16
Primary Completion
2030-06-16
Completion
2032-06-16

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07021261 on ClinicalTrials.gov