NeoPHOEBE: Neoadjuvant Trastuzumab + BKM120 in Combination With Weekly Paclitaxel in HER2-positive Primary Breast Cancer

Inclusion Criteria

• Patient had provided a signed study ICF prior to any screening procedure
• Patient was a female ≥ 18 years of age
• Patient has an ECOG performance status of 0-1
• Patient has a unilateral (multifocal or multicentric disease allowed), histologically confirmed, newly diagnosed early breast cancer >2cm by clinical examination and/or >1.5 cm confirmed by ultrasound or by MRI
• Patient has tumor tissue available for central review of ER, HER2 and PI3K status with centrally confirmed HER2-positive disease and known PI3KCA mutation status
• Patient has adequate bone marrow, renal and liver function
• Patient is able to swallow and retain oral medication

Exclusion Criteria

• Patient has received prior systemic treatment for currently diagnosed disease
• Patient has a known contraindications, hypersensitivity or intolerance to trastuzumab, paclitaxel or products containing cremophor
• Patient has bilateral breast cancer or metastatic disease or inflammatory breast cancer
• LVEF below 50% as determined by MUGA scan or ECHO
• Patient has active cardiac disease or a history of cardiac abnormalities as defined in the protocol
• Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120
• Patient is currently receiving warfarin or other coumarin derived anti-coagulants
• Patient is currently receiving chronic treatment with corticosteroids or another immunosuppressive agents (standard premedication for paclitaxel and local applications allowed)
• Patient is currently receiving treatment with drugs known to be strong inhibitors or inducers of CYP3A
• Patient has certain scores on an anxiety and depression mood questionnaires
• Pregnant or nursing (lactating) women or patients not willing to apply apply highly effective contraception as defined in the protocol