Clinical Trial

Tucatinib, Trastuzumab and Capecitabine With Brain and/or Spinal Radiotherapy (XRT) in Patients With HER2+, HER2 Mutated and/or HER2-amplified Metastatic Breast Cancer and Leptomeningeal Disease: A Multi-centre Phase II, Single Arm Feasibility Study

Recruiting Phase 2
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Summary
The proposed study will evaluate the safety and efficacy of XRT followed by systemic therapy among patients with HER2+, HER2 mutated and/or HER2-amplified metastatic breast cancer and LMD
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2023-08-24; most recent amendment 2026-02-19.
Status change: Not Yet Recruiting → Recruiting 2024-01-05
Trial Details
NCT Number NCT06016387
Lead Sponsor Sunnybrook Health Sciences Centre
Collaborators: Biocon Biologics, Pfizer
Conditions HER2-positive Breast Cancer, LMD
Enrollment 30 participants
Start Date 2023-11-25
Primary Completion 2026-12-31 (estimated)
Study Completion 2028-10-05 (estimated)
Updated on ClinicalTrials.gov 2026-02-23