Demonstrate Efficacy and Safety of Metastatic Breast Cancer

Phase 3

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: CT-P6; Drug: Herceptin; Drug: Paclitaxel

• Registration Number: NCT01084876
• Lead Sponsor: Celltrion

Brief Summary

The purpose of the study is to demonstrate equivalence

Detailed Description

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

Study Timeline

• Study First Submitted: 2010-03-09
• Study First Submitted QC: 2010-03-09
• Study First Posted: 2010-03-11
• Study Start: 2010-06
• Primary Completion: 2012-07
• Study Completion: 2015-03
• Results First Submitted: 2024-10-29
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-22
• Last Update Submitted: 2025-01-22
• Results First Posted: 2025-02-11
• Last Update Posted: 2025-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 475

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT-P6 & Paclitaxel	CT-P6	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.
CT-P6 & Paclitaxel	Paclitaxel	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.
Herceptin & Paclitaxel	Herceptin	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.
Herceptin & Paclitaxel	Paclitaxel	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.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	6 months (up to 24 weeks)	Best Overall Response (BOR) was derived from the overall response across all time points until after Cycle 8 using Independent Tumor Review Committee (ITRC) data in the FAS. Objective Response Rate (ORR) was defined as the number of patients with a BOR of complete response (CR) or partial response (PR) divided by the number of patients in the corresponding population, as assessed by Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1.

Secondary Outcome Measures

Name	Time	Method
Time to Response	Through study completion, approximately 40 months	Time from randomization to observed tumor response (Complete Response or Partial Response), as assessed by RECIST 1.1
Progression Free Survival	Through study completion, approximately 40 months	Time from randomization to radiological progression or death from any cause, as assessed by RECIST 1.1
Overall Survival	Through study completion, approximately 40 months	The number of days between the date of randomization and the date of death from any cause.
Safety Endpoints; Cardiotoxicity	Through study completion, approximately 40 months	Mean change from baseline to endpoint assessment in left ventricular ejection fraction (LVEF) (%)
Time to Progression	Through study completion, approximately 40 months	Time from randomization to determined progressive disease, as assessed by RECIST version 1.1.
Safety Endpoints; Immunogenicity	During treatment, median of 13 cycles (every cycle is 3 weeks)	Assessed by the proportion of patients with development of antibodies to study drug (positive anti-drug antibody \[ADA\] results after the first study drug infusion)
Pharmacokinetic Endpoints; Ctroughss	predose and at 1.5 hours (end of infusion) of each cycle	Trough concentration at steady state

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of