Conditions: Breast Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 452
Healthy volunteers: no

Brief summary:
This randomized, two-arm study evaluated the efficacy and safety of a combination of trastuzumab and capecitabine with or without pertuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. The study population consisted of female patients, whose disease had progressed during or following previous trastuzumab therapy for metastatic disease. All patients in Arm A and Arm B received trastuzumab (8 mg/kg iv as loading dose and then 6 mg/kg iv every 3 weeks thereafter) and capecitabine oral twice daily for 14 days every 3 weeks (1250 mg/m2 twice daily in Arm A and 1000 mg/m2 twice daily in Arm B). In addition, patients in Arm B received pertuzumab (840 mg iv as loading dose and then 420 mg iv thereafter) every 3 weeks. Study treatment continued until disease progression or unacceptable toxicity.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Capecitabine intervention 2: Capecitabine intervention 3: Pertuzumab intervention 4: Trastuzumab
Intervention descriptions: intervention 1: 1000 mg/m2 po twice daily for 14 days every 3 weeks intervention 2: 1250 mg/m2 po twice daily for 14 days every 3 weeks intervention 3: 840 mg iv loading, then 420 mg iv every 3 weeks intervention 4: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks

Protocol document: