NCT06543992

Efficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Methotrexate in Breast Cancer With Leptomeningeal Metastasis

Efficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Methotrexate Via the Ommaya Reservoir in Breast Cancer With Leptomeningeal Metastasis: a Phase II Multicenter Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the efficacy and safety of Intrathecal Administration of Thiotepa in Combination with Methotrexate via the Ommaya Reservoir in Breast Cancer with Leptomeningeal Metastasis

Detailed description

This was a II, single-arm, prospective, multicenter study designed to estimate the efficacy and safety of intrathecal administration of thiotepa in combination with methotrexate via the Ommaya Reservoir in breast cancer with leptomeningeal metastasis. The primary end point was iORR \[complete response (CR) + partial response (PR)\] according to RANO-LM. Scoring based on radiographic assessment in leptomeningeal metastases . A composite score (total score) is calculated and compared with the baseline total score. A 25% worsening in the current score relative to baseline defines radiographic progressive disease. A 50% improvement in the current score defines a radiographic partial response. Resolution of all baseline radiographic abnormalities defines a complete response. All other situations define stable disease. The secondary end points were changes in iPFS, iDoR, ORR, PFS, OS, DoR and exploratory analysis of the relationship between molecular markers and therapeutic efficacy. This study is planned to include 22 patients with leptomeningeal metastasis from breast cancer who meet the entry criteria.

Conditions

• Leptomeningeal Metastasis of Breast Cancer

Interventions

Type	Name	Description
DRUG	Intrathecal Administration of Thiotepa in Combination with Methotrexate via the Ommaya Reservoir	Patients received intrathecal 15mg MTX combination with 10mg thiotepa twice a week for 2 weeks (4 injections) followed by monthly injections of 15mg MTX combination with 10mg thiotepa until an event that meets the criteria for termination occurs.

Timeline

• Start date: 2024-07-13
• Primary completion: 2026-12-13
• Completion: 2026-12-13
• First posted: 2024-08-09
• Last updated: 2024-08-09

Locations

1 site across 1 country: China