NCT05323955: Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib

Breast Cancer Type: HER2+
Hormone Mutations: ER+, PR+
Other Mutations: 
Breast Cancer Tissue: 
Recruitment Status: Not yet recruiting
Phase 2
Drug Category: Therapeutic Antibody, Tyrosine-Kinase Inhibitor

Key Eligibility Criteria:

Gender: All
Age: 18 Years and older (Adult, Older Adult)
Location of Metastases: Brain
Additional Notes: Patient must have systemic disease that is stable or no evidence of extracranial disease; Patients must be currently receiving: (1) first-line trastuzumab/pertuzumab OR (2) second-line Kadcyla/T-DM1 in the metastatic setting OR (3) adjuvant Herceptin/trastuzumab-based therapy or Kadcyla/T-DM1 with isolated intracranial recurrence; Patient must have had adequate local therapy to existing brain lesions greater than or equal to 5mm including surgical resection and/or stereotactic radiosurgery
Exclusions: Patients previously treated with Tykerb/lapatinib, Nerlynx/neratinib, Tukysa/tucatinib or other investigational HER2 tyrosine kinase inhibitor (TKI) (patients treated with adjuvant neratinib allowed if relapse is greater than 12 months after last dose); Patients with 3 or more intracranial (within brain) progressions

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