NCT06678048

Arsenous Acid for Refractory Triple-Negative Breast Cancer

A Single-Arm, Two Stage, Phase II Study of Arsenous Acid Combined With Palliative Chemotherapy for Refractory Triple-Negative Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the progression-free survival (PFS) and safety of arsenous acid in combination with palliative chemotherapy for refractory triple-negative breast cancer following multiple lines of treatment.

Detailed description

The study is a Single-arm, two-stage, Phase II clinical trial. The main purposes of this study are to assess the efficacy and safety of arsenous acid in combination with palliative chemotherapy for refractory triple-negative breast cancer following multiple lines of treatment. Palliative chemotherapy regimen includes Eribulin, Gemcitabine, Utidelone and Vinorelbine, by the treatment of physician's choice (TPC). This study is designed based on Bayesian probability and divided into two stages. All patients will undergo tumor efficacy assessment every two cycles of treatment.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Arsenous Acid plus Chemotherapy	Arsenous Acid , Eribulin, Gemcitabine, Utidelone, Vinorelbine

Timeline

• Start date: 2024-10-23
• Primary completion: 2026-04-22
• Completion: 2026-10-23
• First posted: 2024-11-07
• Last updated: 2025-06-06

Locations

1 site across 1 country: China