*Stratified by prior treatment status (de novo or prior adjuvant/neoadjuvant therapy) and geographic region.
All therapies administered every 3 weeks.
PERJETA dosing: 840 mg loading dose over 60 minutes; 420 mg over 30-60 minutes for subsequent infusions. Herceptin dosing: 8 mg/kg loading dose over 90 minutes; 6 mg/kg over 30-90 minutes for subsequent infusions. Docetaxel dosing: 75 mg/m² over 60 minutes for ≥6 cycles. Dose could be decreased by 25% due to toxicity or increased to 100 mg/m² in those patients who could tolerate this dose; <6 cycles were allowed for unacceptable toxicity.1,2
HER2 overexpression was defined as IHC 3+ or FISH amplification ratio ≥2.0. IHC 3+ is defined as uniform, intense membrane staining in >10% of tumor cells. Patients with a ≥12-month disease-free interval following adjuvant or neoadjuvant therapy, or one prior hormonal treatment for MBC were eligible for enrollment.
IHC=immunohistochemistry; FISH=fluorescence in situ hybridization.