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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

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary endpoint revised
    • Eligibility criteria expanded, about 44 words
    • Study description expanded, about 156 words
    • Study title expanded, about 17 words
    v8
  2. Primary completion date: Oct 5, 2025 to Dec 31, 2026
    • Eligibility criteria shortened, about 5 words
    v7
  3. Eligibility criteria expanded, about 154 words
    • Site contacts updated at 1 of 2 sites
    • Collaborators revised (2)
    v6
  4. Re-verified, no change to tracked fieldsv5
  5. Study sites: 1 to 2v4
Show 2 earlier versionsHide 2 earlier versions
  1. Collaborators revised (2)v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 5, 2023 to Nov 25, 2023
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06016387
Lead Sponsor Sunnybrook Health Sciences Centre
Collaborators: Biocon Biologics, Pfizer
Conditions
(from sponsor)		 HER2-positive Breast Cancer, LMD
Related terms Breast Neoplasms, Meningeal Neoplasms
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov