Evaluation of Neratinib for Treatment and Prevention of Subsequent CNS Event(s) in Patients With Brain Metastasis of Advanced HER2 Positive Breast Cancer

"As per investigator's choice, eligible subjects in all cohort will receive:~* Neratinib, administered continuously at a dose of 240 mg orally once a day in combination with:~ * Capecitabine, administered continuously at a dose of 750 mg/m2, orally, twice a day (=daily dose of 1500 mg/m2) from D1 toD14 (21 days cycle) (preferred option) or~ * Vinorelbine, I.V. 25 mg/m2 on D1 and D8 (21 days cycle) or~ * Paclitaxel, I.V. 80 mg/m2 on D1, D8, and D15 (21 days cycle) Important note: The possibility to combine trastuzumab, loading dose 8 mg/kg IV followed by 6 mg/kg Q3W IV or SC 600 mg Q3W, to one of these above treatments is left at investigator's discretion OR~* Neratinib, administered continuously at a dose of 160 mg, orally, once a day in combination with:~ * T-DM1, I.V. 3.6mg/m2 on D1 (21 days cycle) (preferred option)"