Evaluate Safety, Efficacy and Pharmacokinetics (Compare)

A Double-Blind, Randomized, Parallel Phase I/IIb Study to Evaluate Initial Safety and Efficacy, Comparative Pharmacokinetics, and Immunogenicity for CT-P6 and Herceptin in Metastatic Breast Cancer

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

Study Overview

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

Detailed Description

Patients will receive CT-P6 or Herceptin.

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Phase 2; Phase 1

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 a Her 2 over-expression
• Have Eastern Cooperative Oncology Group (ECOG) 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
Experimental: CT-P6 & Paclitaxel; 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.	Drug: CT-P6; CT-P6: administered every 3 weeks; Drug: Paclitaxel; Paclitaxel: administered every 3 weeks
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 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.	Drug: Paclitaxel; Paclitaxel: administered every 3 weeks; Drug: Herceptin; Herceptin: administered every 3 weeks; Other Names: Trastuzumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration Time Curve at Steady State (AUCss)	Area under the concentration time curve at steady state (AUCss), defined as area under the concentration-time curve between Cycle 8 to Cycle 9. The primary endpoint was reached at 6 months (8 treatment cycle; Main Study Treatment Period).	3, 6, 12, 24, 72, 168, 336, 504 hours predose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trough Concentration at Steady State (CtroughSS)	Trough concentration at steady state (CtroughSS), defined as trough concentration at steady state. The secondary endpoint was reached at 6 months (8 treatment cycle; Main Study Treatment Period).	3, 6, 12, 24, 72, 168, 336, 504 hours predose
Cardiotoxicity	Cardiac Ejection Fraction Assessment, defined as Mean change from baseline to endpoint assessment in left ventricular ejection fraction (LVEF, Unit: %) from the independent tumor review committee (ITRC).	Up to approximately 1 year
Immunogenicity	Immunogenicity, defined as proportion of patients with antibodies to study drug (positive for antidrug antibody [ADA] result after the first study infusion).	every 4 cycles (each cycle is 3 weeks), Up to approximately 5.5 years
Overall Response Rate (ORR; Complete Response [CR] Plus Partial Response [PR]) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1	Overall response rate (ORR) based on best overall response (BOR) during the Main Study Treatment Period and up to 1-year treatment from the independent tumor review committee (ITRC) and Investigator. ORR (complete response [CR] plus partial response [PR]), as assessed by Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 To be assigned a best ORR of PR or CR, changes in tumour assessments must be confirmed no less than 4 weeks after the criteria for response were met.	every 6 weeks (up to cycle 4) or 12 weeks (after cycle 4) (every cycle is 3 weeks), up to 6 months in Main treatment period and up to 1 year
Serum Human Epidermal Growth Factor Receptor-2 (HER-2) Shed Antigen Value	Serum Human epidermal growth factor receptor-2 (HER-2) shed antigen values at baseline (Cycle 1, Day 1) and the last assessments.	day 1 of each cycle (every cycle is 3 weeks), Up to approximately 5.5 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: March 5, 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 23, 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-P6/1.1