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NALA, 2020 NCT01808573

neratinib plus capecitabine (n=307) vs. lapatinib plus capecitabine (n=314)

randomized controlled trial

Studied treatment

neratinib plus capecitabine
neratinib: 240 mg PO once daily continuously in 21-day cycles with no break between cycles / capecitabine: 1,500 mg/m2 PO daily in 2 evenly spaced doses [750 mg/m2 twice a day] on days 1-14 of 21-day cycles ///// Prophylactic antidiarrheal medication was mandated for the duration of cycle 1 in this group

Control treatment

lapatinib plus capecitabine
lapatinib: 1,250 mg PO once daily continuously / capecitabine: 2,000 mg/m2 PO daily in 2 evenly spaced doses [1,000 mg/m2 twice a day] on days 1-14 of 21-day cycles

Patients

la/mBC - HER2 positive - 2nd Line (L2)

Method

open-label

203 sites in 28 countries in Europe, North and South America, Asia, and Australia

P3 / Coprimary end points were analyzed using an overall type I error rate of 0.01 for PFS and 0.04 for OS. No interim analysis. (trial was considered positive if either PFS or OS were statistically significant at the split alpha level)

Remark

Neratinib plus capecitabine significantly improved PFS but not significantly for OS, compared to lapatinib plus capecitabine.

NALA (brain metastases), 2020 NCT01808573

neratinib plus capecitabine (n=51) vs. lapatinib plus capecitabine (n=50)

randomized controlled trial

Studied treatment

neratinib plus capecitabine
neratinib: 240 mg PO once daily continuously in 21-day cycles with no break between cycles / capecitabine: 1,500 mg/m2 PO daily in 2 evenly spaced doses [750 mg/m2 twice a day] on days 1-14 of 21-day cycles ///// Prophylactic antidiarrheal medication was mandated for the duration of cycle 1 in this group

Control treatment

lapatinib plus capecitabine
lapatinib: 1,250 mg PO once daily continuously / capecitabine: 2,000 mg/m2 PO daily in 2 evenly spaced doses [1,000 mg/m2 twice a day] on days 1-14 of 21-day cycles

Patients

la/mBC - HER2 positive - 2nd Line (L2)

Method

open-label

203 sites in 28 countries in Europe, North and South America, Asia, and Australia

P3 / Coprimary end points were analyzed using an overall type I error rate of 0.01 for PFS and 0.04 for OS. No interim analysis. (trial was considered positive if either PFS or OS were statistically significant at the split alpha level).Descriptive analysis for this study population (patients with brain metastasis)

Remark

Descriptive analysis for this population (patients with brain metastasis)