Demonstrate Efficacy and Safety of Metastatic Breast Cancer (Compare)

Celltrion Healthcare

Status and phase: Completed; Phase 3

Conditions: Metastatic Breast Cancer

Treatments: Drug: Paclitaxel; Drug: CT-P6; Drug: Herceptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01084876

CT-P6/3.1

Details and patient eligibility

About

The purpose of the study is to demonstrate equivalence

Full description

Patients will receive CT-P6 or Herceptin every 3 weeks.

Enrollment: 475 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Are females
• Have Her 2 over-expression
• Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion criteria

• Current clinical or radiographic evidence central nervous system (CNS) metastases
• Current Known infection
• Pregnant or nursing mother

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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475 participants in 2 patient groups

CT-P6 & Paclitaxel

Experimental group

Description:

CT-P6 was administered at a loading dose of 8 mg/kg body weight by intravenous (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 or discontinuation.

Treatment:

Drug: CT-P6

Drug: Paclitaxel

Herceptin & Paclitaxel

Active Comparator group

Description:

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 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 or discontinuation.

Treatment:

Drug: Herceptin

Drug: Paclitaxel