ExteNET was a pivotal phase 3, global, multicenter, randomized, double-blind, placebo-controlled study2,3
NERLYNX is the first and only HER2-directed small molecule approved in HER2+ early breast cancer2,3,20
Event-based OS analysis was reached at 8 years1,‡
- Study population: 2840 women with early-stage HER2+ breast cancer and locally confirmed HER2 status; all patients had prior trastuzumab-based therapy§
- Primary endpoint: invasive disease-free survival (iDFS)*
- Secondary endpoints: overall survival, DFS–DCIS, distant DFS, time to distant recurrence, CNS metastases, safety
- Stratification: nodes (0, 1-3 or 4+), ER/PR status, concurrent vs sequential trastuzumab-based therapy
*Invasive disease-free survival defined as the time between the date of randomization to the first occurrence of invasive recurrence (local/ regional, ipsilateral, or contralateral breast cancer), distant recurrence, or death from any cause, with 2 years and 28 days of follow-up.3
†Results of ExteNET are supported by descriptive analyses after 5 years of follow-up, with 74.5% (2117/2840) of patients reconsented.2
‡A definitive analysis of OS was planned when 248 deaths had occurred in the ITT population; median follow-up of 8.0 years.1
§Select exclusion criteria: clinically significant cardiac, GI, or psychiatric comorbidities; inability to swallow pills.2
CNS: central nervous system; DFS-DCIS: disease-free survival including ductal carcinoma in situ; DFS: disease-free survival; ER: estrogen receptor; HER: human epidermal growth factor receptor; ITT: intent-to-treat; OS: overall survival; PR: progesterone receptor.