Fig. 2.

Study profile. Primary efficacy analysis based on a data cut-off date (24 August 2016) when all patients had either completed Week 33 tumour assessments or discontinued study treatment earlier. Secondary analyses based on a data cut-off date (11 January 2017) when all patients had either completed Week 53 tumour assessments or discontinued study treatment earlier. ^aNumber does not include patients who completed treatment with paclitaxel per protocol. ^bPatients who completed all follow-up as required by the protocol. ^cStatus at time of data cut-off, using data up to 378 days post-randomisation. ^dReasons for exclusion from the per protocol population were comparable between the groups. The most frequent reason for exclusion was “no measurable disease at baseline per central reviewer” (31 [8.8%] patients in the PF-05280014 group vs. 25 [7.0%] patients in the trastuzumab-EU group), followed by “missing, not evaluable or equivocal HER2 status by central laboratory” (27 [7.7%] vs. 25 [7.0%] patients). HER2 human epidermal growth factor receptor 2, ITT intent-to-treat, PK pharmacokinetics, trastuzumab-EU reference trastuzumab sourced from the European Union