NCT05535413

UTD1 Combined With Capecitabine in Metastatic HER2-negative Breast Cancer Patients With Brain Metastases

A Single-arm, Multicenter, Open-labeled Clinical Study of UTD1 Combined With Capecitabine in Metastatic HER2-negative Breast Cancer Patients With Brain Metastases

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Hunan Cancer Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, multicenter, open-labeled clinical study of UTD1 combined with Capecitabine in metastatic HER2-negative breast cancaner patients with brain metastases. This study aims to evaluate the efficacy and safety of UDT1 combined with capecitabine in metastatic HER2-negative breast cancer patients with brain metastases.

Conditions

• Metastatic HER2 Negative Breast Carcinoma
• Brain Metastases
• Capecitabine
• UDT1

Interventions

Type	Name	Description
DRUG	UTD1 combined with capecitabine	UTD1: 30mg/m2/day, once a day, continuously from day 1 to day 5, 21 days as a treatment cycle. Capecitabine: 2000mg / m2 / day, continuously from day 1 to day 14, orally twice a day, 21 days as a treatment cycle.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-10-31
• Completion: 2025-07-01
• First posted: 2022-09-10
• Last updated: 2025-04-25

Locations

1 site across 1 country: China