Phase 1b/2 Study of BKM120 Plus Trastuzumab in Patients With HER2-positive Breast Cancer

Inclusion Criteria: * World Health Organization (WHO) Performance Status of ≤ 2 * Patients with HER2+ breast cancer by local laboratory testing (immunohistochemistry \[IHC\] 3+ staining or fluorescence in situ hybridization \[FISH\] confirmation for IHC 2+ and 1+) * Documented tumor resistance to trastuzumab: * Recurrence while on trastuzumab or within 12 months since the last infusion for patients who received trastuzumab as adjuvant treatment * Progression while on or within 4 weeks since the last infusion of trastuzumab for patients who received trastuzumab for metastatic disease. * Documented evidence of progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) on trastuzumab-based therapy defined as: * Phase Ib: at any time before study entry * Phase II: within 16 weeks before date of first dosing * Received at least 1 but no more than 4 prior anit-HER2 based regimens including at least 1 regimen containing trastuzumab (adjuvant or neo-adjuvant trastuzumab will be considered as one prior regimen). HER2 directed therapies are defined as comprising trastuzumab, lapatinib, and trastuzumab-DM1 (T-DM1) only. • Phase II only: trastuzumab, T-DM1 or lapatinib must be part of the most recent line of therapy * Previous lines of cytotoxic chemotherapy: * Phase Ib: no more than 4 lines of cytotoxic chemotherapy * Phase II: no more than 3 lines of cytotoxic chemotherapy Measurable disease: * Phase Ib: patient has at least one measurable lesion or non-measurable disease as defined per RECIST * Phase II: patient has at least one measureable lesion as defined per RECIST \|\| Specific Inclusion Criteria for patients in BM cohorts: * Patient has evidence of progressing brain metastases and/or new metastatic brain lesion(s) without leptomeningeal disease. * Patient has received prior WBRT and/or SRS at at \>28 and \>/= 14 days, respectively, prior to starting study drug and the patient must have recovered from the side effects of the therapy * WHO performance status of \</=1 * PT INR \</= 1.5 * Any number of prior HER2-directed and cytotoxic regimens, and the most recent line may be any type of anti-neoplastic therapy \|\| Exclusion Criteria: * Patients with untreated brain metastases * Patients with acute or chronic liver, renal disease or pancreatitis * Patients with any peripheral neuropathy ≥ Common Terminology Criteria for Adverse Events (CTCAE) grade 2 * Patients with a history of mood disorders or ≥ CTCAE grade 3 anxiety * Patient with clinical manifest diabetes mellitus or steroid-induced diabetes mellitus \|\| Specific Exclusion Criteria for patients in BM cohorts * Prior treatment with capecitabine * Patient has known dihydropyrimidine dehydrogenase (DPD) deficiency * Patient is currently receiving treatment with EIAED * Other protocol-defined inclusion/exclusion criteria may apply