Neratinib

In the phase III NALA trial (NCT01808573), neratinib and capecitabine were compared with lapatinib and capecitabine in 621 patients with HER2-positive metastatic breast cancer who received two or more HER2-directed regimens in the metastatic setting. PFS and OS were co-primary end points. Secondary end points were time to intervention for metastatic central nervous system (CNS) disease and duration of response. Patients with stable or asymptomatic CNS disease were included.[83][Level of evidence B1]

In the phase III NALA trial (NCT01808573), neratinib and capecitabine were compared with lapatinib and capecitabine in 621 patients with HER2-positive metastatic breast cancer who received two or more HER2-directed regimens in the metastatic setting. PFS and OS were co-primary end points. Secondary end points were time to intervention for metastatic central nervous system (CNS) disease and duration of response. Patients with stable or asymptomatic CNS disease were included.[83][Level of evidence B1]

Patients who received neratinib and capecitabine had significantly improved PFS (HR, 0.76; 95% CI, 0.63–0.93). OS between the two arms was not different.

In the phase III NALA trial (NCT01808573), neratinib and capecitabine were compared with lapatinib and capecitabine in 621 patients with HER2-positive metastatic breast cancer who received two or more HER2-directed regimens in the metastatic setting. PFS and OS were co-primary end points. Secondary end points were time to intervention for metastatic central nervous system (CNS) disease and duration of response. Patients with stable or asymptomatic CNS disease were included.[83][Level of evidence B1]

The cumulative incidence of intervention for CNS disease was 22.8% (95% CI, 15.5%–30.9%) for patients who received neratinib versus 29.2% (95% CI, 22.5%–36.1%) for patients who received lapatinib.

In the phase III NALA trial (NCT01808573), neratinib and capecitabine were compared with lapatinib and capecitabine in 621 patients with HER2-positive metastatic breast cancer who received two or more HER2-directed regimens in the metastatic setting. PFS and OS were co-primary end points. Secondary end points were time to intervention for metastatic central nervous system (CNS) disease and duration of response. Patients with stable or asymptomatic CNS disease were included.[83][Level of evidence B1]

Duration of response was 8.5 months for patients who received neratinib versus 5.6 months for patients who received lapatinib.

In the phase III NALA trial (NCT01808573), neratinib and capecitabine were compared with lapatinib and capecitabine in 621 patients with HER2-positive metastatic breast cancer who received two or more HER2-directed regimens in the metastatic setting. PFS and OS were co-primary end points. Secondary end points were time to intervention for metastatic central nervous system (CNS) disease and duration of response. Patients with stable or asymptomatic CNS disease were included.[83][Level of evidence B1]

Diarrhea, nausea, palmar-plantar erythrodysesthesia, and vomiting were the most common adverse events, with grade 3 diarrhea occurring in 24.4% of patients who received neratinib. Antidiarrheal medications were required in the neratinib arm and used by 98.3% of those patients.

In the phase III NALA trial (NCT01808573), neratinib and capecitabine were compared with lapatinib and capecitabine in 621 patients with HER2-positive metastatic breast cancer who received two or more HER2-directed regimens in the metastatic setting. PFS and OS were co-primary end points. Secondary end points were time to intervention for metastatic central nervous system (CNS) disease and duration of response. Patients with stable or asymptomatic CNS disease were included.[83][Level of evidence B1]

Quality-of-life scores were similar between the two groups.