Conditions: Metastatic Breast Cancer
Keywords: Herceptin Her 2-positive metastatic breast cancer CT-P6
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 143
Healthy volunteers: no

Brief summary:
The purpose of the study is to demonstrate equivalent pharmacokinetics (PK)

Detailed description:
Patients will receive CT-P6 or Herceptin.

Arms:
arm 1: CT-P6 was administered at a loading dose of 8 mg/kg body weight by IV infusion over 90 minutes on Day 1, Cycle 1, then at 6 mg/kg repeated at 3-weekly intervals until disease progression, death, or discontinuation.

Paclitaxel was administered at a dose of 175 mg/m2 body surface area (BSA) as a continuous 3-hour IV infusion on the day following the first dose of study drug (CT-P6). If the first dose of study drug was well tolerated, subsequent doses of paclitaxel were given immediately after the next dose of study drug. Paclitaxel cycles were repeated every 3 weeks until disease progression, death, intolerable toxicity, or discontinuation. arm 2: Herceptin was administered at a loading dose of 8 mg/kg body weight by IV infusion over 90 minutes on Day 1, Cycle 1, then at 6 mg/kg repeated at 3-weekly intervals until disease progression, death, or discontinuation.

Paclitaxel was administered at a dose of 175 mg/m2 body surface area (BSA) as a continuous 3-hour IV infusion on the day following the first dose of study drug (Herceptin). If the first dose of study drug was well tolerated, subsequent doses of paclitaxel were given immediately after the next dose of study drug. Paclitaxel cycles were repeated every 3 weeks until disease progression, death, intolerable toxicity, or discontinuation.

Interventions: intervention 1: CT-P6 intervention 2: Herceptin intervention 3: Paclitaxel
Intervention descriptions: intervention 1: CT-P6: administered every 3 weeks intervention 2: Herceptin: administered every 3 weeks intervention 3: Paclitaxel: administered every 3 weeks

Protocol document: