Demonstrate Efficacy and Safety of Metastatic Breast Cancer (Compare)

A Double-blind, Randomised, Parallel Group, Phase III Study to Demonstrate Equivalent Efficacy and Comparable Safety of CT-P6 and Herceptin, Both in Combination With Paclitaxel, in Patients With Metastatic Breast Cancer

The purpose of the study is to demonstrate equivalence

Study Overview

• Status: Completed
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Drug: CT-P6; Drug: Herceptin; Drug: Paclitaxel

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 475
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Herceptin & 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.	Drug: Herceptin; Administered every 3 weeks; Other Names: Trastuzumab; Drug: Paclitaxel; Administered every 3 weeks
Experimental: CT-P6 & 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.	Drug: CT-P6; Administered every 3 weeks; Drug: Paclitaxel; Administered every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate	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.	6 months (up to 24 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Progression	Time from randomization to determined progressive disease, as assessed by RECIST version 1.1.	Through study completion, approximately 40 months
Time to Response	Time from randomization to observed tumor response (Complete Response or Partial Response), as assessed by RECIST 1.1	Through study completion, approximately 40 months
Progression Free Survival	Time from randomization to radiological progression or death from any cause, as assessed by RECIST 1.1	Through study completion, approximately 40 months
Overall Survival	The number of days between the date of randomization and the date of death from any cause.	Through study completion, approximately 40 months
Safety Endpoints; Cardiotoxicity	Mean change from baseline to endpoint assessment in left ventricular ejection fraction (LVEF) (%)	Through study completion, approximately 40 months
Safety Endpoints; Immunogenicity	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)	During treatment, median of 13 cycles (every cycle is 3 weeks)
Pharmacokinetic Endpoints; Ctroughss	Trough concentration at steady state	predose and at 1.5 hours (end of infusion) of each cycle

Collaborators and Investigators

• Sponsor: Celltrion
• Investigators: Principal Investigator: Investigational Site, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2010
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: March 9, 2010
• First Submitted That Met QC Criteria: March 9, 2010
• First Posted (Estimated): March 11, 2010

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Herceptin; metastatic breast cancer; Her 2-positive; CT-P6
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Trastuzumab; Paclitaxel
• Other Study ID Numbers: CT-P6/3.1