NCT05323955
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
https://ClinicalTrials.gov/show/NCT05323955