NCT07021261

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

A Multicenter, Open-Label, Randomized, Phase III Study Comparing UTD2 Combined With Capecitabine to Capecitabine Monotherapy as Adjuvant Therapy for Triple-Negative Breast Cancer Patients Who Did Not Achieve Pathological Complete Response

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 440 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, randomized, open-label phase III clinical study that aims to evaluate the efficacy and safety of the combination therapy involving the use of oral UTD2 capsule in conjunction with capecitabine, as compared to the efficacy and safety of capecitabine monotherapy. The study is specifically focused on patients diagnosed with triple-negative early breast cancer who, after undergoing neoadjuvant therapy, did not achieve a pathological complete response (pCR). The primary objective of this research is to assess whether the addition of UTD2 to capecitabine can provide a more effective adjuvant treatment option for this particular group of patients.

Conditions

• Breast Cancer
• TNBC

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-16
• Primary completion: 2030-06-16
• Completion: 2032-06-16
• First posted: 2025-06-13
• Last updated: 2025-06-13