NCT06533722

Adaptive Therapy for Post-Second-Line Advanced Breast Cancer

A Phase II Study of the Efficacy and Safety of Adaptive Therapy for Metastatic Refractory Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• 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 explore the efficacy and safety of adaptive therapy in the treatment of post-second-line metastatic breast cancer.

Detailed description

This is a phase II, prospective, single arm clinical trial. The objective of the study is to evaluate the efficacy and safety of adaptive therapy in the treatment of post-second-line advanced breast cancer. The therapy regimen primarily including Gemcitabine, Vinorelbine, or Eribulin, will be selected by the investigator based on current guidelines, available treatments, and an assessment of the patient's clinical status, preferences, and financial situation. This study plans to recruit 10 subjects.

Conditions

• HER2-negative Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine, Vinorelbine, or Eribulin	Gemcitabine Gemcitabine 1000 mg/m\^2 IV on days 1 and 8, cycled every 33 days Vinorelbine 25 mg/m\^2 IV on days 1 and 8, cycled every 33 days Eribulin 1.4 mg/m\^2 IV on days 1 and 8, cycled every 33 days

Timeline

• Start date: 2024-08-04
• Primary completion: 2024-09-20
• Completion: 2025-05-28
• First posted: 2024-08-01
• Last updated: 2025-06-10

Locations

1 site across 1 country: China