Statistically conclusive or suggested result Inconclusive results Uncertain results Safety results

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)

suggested 50 % decrease in DOR

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)--
versus placebo
neratinib vs. placebo 1 none---
versus trastuzumab plus capecitabine
tucatinib plus trastuzumab plus capecitabine vs. trastuzumab plus capecitabine 2 noneinconclusive results for: AE leading to treatment discontinuation (any grade)

statistically conclusive 34 % decrease in deaths (OS) but the degree if certainty is unassessable

statistically conclusive 46 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable

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