drugset / Trial / NCT05800275

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

NCT05800275

Phase 2 Recruiting 30 enrolled UNICANCER Seagen Inc. · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-12-18
Primary completion
2026-12
Completion
2027-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Trastuzumab Monoclonal antibody 150 mg Intrathecal
Subject Tucatinib Small molecule 300 mg Oral