NCT05800275

Capecitabine, Tucatinib, and Intrathecal Trastuzumab for Breast Cancer Patients With Leptomeningeal Disease

Multicentric Single Arm Phase II Study Evaluating the Efficacy of Association of Tucatinib, Capecitabine and Intra-CSF Trastuzumab in HER2 Amplified Breast Cancer Patients With Leptomeningeal Metastases

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the efficacy of tucatinib and capecitabine in combination with intrathecal trastuzumab on overall survival rate at 12 months in HER2-positive metastatic breast cancer (MBC) patients with proven leptomeningeal evolution and requiring intrathecal therapy.

Conditions

• Leptomeningeal Metastasis
• Leptomeningeal Disease
• HER2-positive Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Tucatinib Oral Tablet	300 mg, twice daily
DRUG	Capecitabine tablets	1000 mg/m², twice daily on days 1-14 of each 21-day cycle
DRUG	Trastuzumab Injection	Intrathecal by lumbar puncture or Ommaya Reservoir, 150 mg weekly

Timeline

• Start date: 2023-12-18
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2023-04-05
• Last updated: 2025-11-18

Locations

11 sites across 1 country: France