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OpenTrials
Completed

NCT Number: NCT01084863

Evaluate Safety, Efficacy and Pharmacokinetics

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

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Samsung Medical Center

Seoul, South Korea

About this study

Patients will receive CT-P6 or Herceptin.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT-P6

Drug

CT-P6: administered every 3 weeks

Herceptin

Drug

Herceptin: administered every 3 weeks

Other names: Trastuzumab

paclitaxel

Drug

Paclitaxel: administered every 3 weeks

Primary outcomes

  1. Area Under the Concentration Time Curve at Steady State (AUCss)

    Time frame: 3, 6, 12, 24, 72, 168, 336, 504 hours predose

    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).

Secondary outcomes

  1. Trough Concentration at Steady State (CtroughSS)

    Time frame: 3, 6, 12, 24, 72, 168, 336, 504 hours predose

    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).

  2. Cardiotoxicity

    Time frame: Up to approximately 1 year

    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).

  3. Immunogenicity

    Time frame: every 4 cycles (each cycle is 3 weeks), Up to approximately 5.5 years

    Immunogenicity, defined as proportion of patients with antibodies to study drug (positive for antidrug antibody [ADA] result after the first study infusion).

  4. Overall Response Rate (ORR; Complete Response [CR] Plus Partial Response [PR]) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

    Time frame: 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

    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.

  5. Serum Human Epidermal Growth Factor Receptor-2 (HER-2) Shed Antigen Value

    Time frame: day 1 of each cycle (every cycle is 3 weeks), Up to approximately 5.5 years

    Serum Human epidermal growth factor receptor-2 (HER-2) shed antigen values at baseline (Cycle 1, Day 1) and the last assessments.

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study title

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

Acronym: Compare

Important dates

Study start
2010
Primary completion
2011
Study completion
2023
First posted
Mar 11, 2010
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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