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OpenTrials
Completed

NCT Number: NCT00876486

Evaluate the Efficacy and Safety of Genexol®-PM Compared to Genexol® in Recurrent or Metastatic Breast Cancer

Phase III trial to evaluate the efficacy and safety of Genexol®-PM compared to Genexol® in subjects with recurrent or metastatic breast cancer.

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Key information

Conditions

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

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Subjects should meet all of the following criteria to participate in the trial.

  • Subjects who aged 18 years or older.
  • Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial.
  • Subjects who have histologically or cytologically confirmed breast cancer with evidence of recurrence or metastasis.
  • If subjects have received Taxanes as neo-adjuvant or adjuvant therapy, the subjects should have relapsed with breast cancer after 12 months of completing neo-adjuvant or adjuvant therapy with Taxanes.
  • Subjects who have measurable disease in accordance with the RECIST criteria

Treatment and study plan

Genexol-PM®

Drug

Genexol-PM® 260mg/m2, intravenous infusion over 3 hours, every 3 weeks

Genexol®

Drug

Genexol® 175mg/m2, intravenous infusion over 3 hours, every 3 weeks

Primary outcomes

  1. Objective Response Rate

    Time frame: 6 months

    Evaluate the efficacy of Genexol®-PM versus Genexol® in subjects with recurrent or metastatic breast cancer based on Objective Response Rate.

Secondary outcomes

  1. Overall Survival, Progress Free Survival, Time to Tumor Progression, Duration of Overall Response

    Time frame: Event driven

    To evaluate the efficacy of Genexol®-PM relative to Genexol® as measured by Overall Survival, Progress Free Survival, Time to Tumor Progression, Duration of Overall Response.

  2. Safety and toxicity

    Time frame: Throughout study

    To compare the safety and toxicity of Genexol®-PM with those of Genexol®

Sponsors and collaborators

Lead sponsor

Samyang Biopharmaceuticals Corporation

Industry

Registry information

Official study title

A Open-label, Randomized, Parallel, Phase III Trial to Evaluate the Efficacy and Safety of Genexol®-PM Compared to Genexol®(Conventional Paclitaxel With Cremorphor EL) in Subjects With Recurrent or Metastatic Breast Cancer

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Apr 6, 2009
Registry last updated
May 1, 2017

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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