Ten fifty b phase ii11/19/2023 ![]() Seventy-six percent were patients with hormone receptor (HR) positive metastatic breast cancer (MBC) and 24% were patients with HR negative MBC. ![]() Seventy-six percent of patients were white, 16% Asian, and 8% African-American. Response rate, progression free survival, and overall survival were also evaluated.Ģ5 patients were enrolled with median age of 66 (range 60-79). The association between tolerability, defined as dose reduction and number of completed courses, and log 2 Cancer and Aging Research Group (CARG) toxicity risk score was assessed using a Student's t-test and linear regression, respectively. Patients aged 60 or older with histologically proven metastatic breast cancer and HER2 amplification (defined by ASCO/CAP guideline) or HER2/HER3 activating mutation were enrolled to receive neratinib at 240 mg daily in 28-day cycles. This phase II trial evaluates the safety and tolerability of neratinib in adults ≥60. The major toxicity of neratinib is diarrhea, which affects up to 90% of patients. Neratinib is a novel HER1, HER2, HER4 tyrosine kinase inhibitor that has recently been granted FDA approval for treatment of breast cancer. The tolerability and efficacy of targeted therapy in older adults with cancer has not been adequately studied.
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