First-Line Pertuzumab (P), Trastuzumab (H), And Taxane Therapy For Her2-Positive Locally Recurrent/Metastatic Breast Cancer (Lr/Mbc): Interim Safety Results (N=704) From Peruse

548^ Background: Combining P with 1st-line H + docetaxel (DOC) in pts with HER2-positive mBC significantly improved progression-free survival (PFS) and overall survival (OS) in the randomized phase III CLEOPATRA trial. PERUSE is assessing the safety of 1st-line P + H + investigator’s chosen taxane in routine oncology practice. Methods: In the ongoing multicenter single-arm phase IIIb PERUSE study, pts with HER2-positive LR/mBC, ECOG PS ≤2 and no prior systemic therapy for LR/mBC (except endocrine therapy) receive P (840→420 mg q3w), H (8→6 mg/kg q3w) and a taxane (DOC, paclitaxel [PAC] or nab-PAC) until disease progression (PD) or unacceptable toxicity. Pts will be followed until 45 mo after last pt enrollment. The primary endpoint is safety, including grade (G) ≥3 AEs. Secondary endpoints include PFS, OS, objective response rate and QoL. We report a prespecified interim analysis reviewed by the Independent Data Monitoring Committee. Results: As of 13 Sep 2013, 704 of the planned 1500 pts had completed ≥6...