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

• Status: Completed
• Trial end date: 2015-02-18
• Target enrollment: 0
• Participant gender: Female

Summary

This randomized, parallel cohort, two stage, double-blind, placebo-controlled study evaluated the oral PI3K inhibitor BKM120 in combination with trastuzumab and paclitaxel in HER2-positive, PIK3CA wild-type and PIK3CA mutant primary breast cancer prior to surgery (neo-adjuvant setting).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Collaborators: Breast International Group; German Breast Group; German Breast Group (GBG); SOLTI Breast Cancer Research Group
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel; Trastuzumab

Criteria

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