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

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 ID
NCT06016387
Phase
PHASE2
Sponsor
Sunnybrook Health Sciences Centre
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Tucatinib 150 MG
  • Trastuzumab
  • Capecitabine
  • Brain & Spinal Radiation
Locations (sample)
  • Ottawa, Ontario, Canada|45.41117,-75.69812
  • Toronto, Ontario, Canada|43.70643,-79.39864

Key Eligibility Criteria

  • Men or women with HER2+, HER2 mutated and/or HER2-amplified metastatic breast cancer. HER2+ status will be defined in accordance with ASCO-CAP 2018…
  • Evidence of LMD\* in the brain and/or spine (either positive cerebral spinal fluid cytology and/or magnetic resonance imaging evidence of LMD). Mea…
  • Age 18+ at time of consent;
  • More than 14 days or 5 half-lives from the last dose of any experimental agent is required, whichever is greater;

For full eligibility, visit ClinicalTrials.gov.

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