| Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
la/mBC - HER2 positive - 1st Line (L1) breast cancer - HER2-positive la/mBC - HER2 positive la/mBC - HER2 positive - 1st Line (L1) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
la/mBC - HER2 positive - 2nd Line (L2) breast cancer - HER2-positive la/mBC - HER2 positive la/mBC - HER2 positive - 2nd Line (L2) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus lapatinib plus capecitabine | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| neratinib plus capecitabine vs. lapatinib plus capecitabine | 2 | statistically conclusive 26 % decrease in progression or deaths (PFS) | inconclusive results for: deaths (OS); objective responses (ORR); Anaemia AE (grade 3-4); Asthenia AE (grade 3-4); Back pain AE (grade 3-4); Constipation AE (grade 3-4); Decreased appetite AE (grade 3-4); Diarrhoea AE (grade 3-4); Fatigue AE (grade 3-4); Headache AE (grade 3-4); Nausea AE (grade 3-4); Palmar–plantar erythrodysesthesia syndrome AE (grade 3-4); Pyrexia AE (grade 3-4); Rash AE (grade 3-4); Stomatitis AE (grade 3-4); Vomiting AE (grade 3-4); Weight decreased AE (grade 3-4) | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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