NALA was a pivotal phase 3, global, multicenter, randomized, open-label study of NERLYNX + capecitabine vs lapatinib + capecitabine3,26
- Study population: 621 adults with HER2+ mBC (HER2 status was confirmed centrally); all patients had ≥2 prior lines of HER2-directed therapy for mBC; asymptomatic or stable brain metastases permitted
- Co-primary endpoints: PFS (confirmed centrally) and OS
- Secondary endpoints: PFS (confirmed locally), ORR, DoR, time to intervention for symptomatic CNS metastases, safety, health outcomes
- Stratification: Number of prior HER2 therapies for mBC; hormone receptor status; disease location; geographic location