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OpenTrials
Completed

NCT Number: NCT01084876

Demonstrate Efficacy and Safety of Metastatic Breast Cancer

The purpose of the study is to demonstrate equivalence

Completed

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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 3

Primary location

Samsung Medical Center

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

CT-P6

Drug

Administered every 3 weeks

Herceptin

Drug

Administered every 3 weeks

Other names: Trastuzumab

paclitaxel

Drug

Administered every 3 weeks

Primary outcomes

  1. Objective Response Rate

    Time frame: 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 outcomes

  1. Time to Progression

    Time frame: Through study completion, approximately 40 months

    Time from randomization to determined progressive disease, as assessed by RECIST version 1.1.

  2. Time to Response

    Time frame: Through study completion, approximately 40 months

    Time from randomization to observed tumor response (Complete Response or Partial Response), as assessed by RECIST 1.1

  3. Progression Free Survival

    Time frame: Through study completion, approximately 40 months

    Time from randomization to radiological progression or death from any cause, as assessed by RECIST 1.1

  4. Overall Survival

    Time frame: Through study completion, approximately 40 months

    The number of days between the date of randomization and the date of death from any cause.

  5. Safety Endpoints; Cardiotoxicity

    Time frame: Through study completion, approximately 40 months

    Mean change from baseline to endpoint assessment in left ventricular ejection fraction (LVEF) (%)

  6. Safety Endpoints; Immunogenicity

    Time frame: 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)

  7. Pharmacokinetic Endpoints; Ctroughss

    Time frame: predose and at 1.5 hours (end of infusion) of each cycle

    Trough concentration at steady state

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study title

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

Acronym: Compare

Important dates

Study start
2010
Primary completion
2012
Study completion
2015
First posted
Mar 11, 2010
Registry last updated
Feb 11, 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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