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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT00876486
First received: April 3, 2009
Last updated: April 27, 2017
Last verified: April 2017
  Purpose
Phase III trial to evaluate the efficacy and safety of Genexol®-PM compared to Genexol® in subjects with recurrent or metastatic breast cancer.

Condition Intervention Phase
Breast Cancer Drug: Genexol-PM® Drug: Genexol® Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Samyang Biopharmaceuticals Corporation:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • Safety and toxicity [ Time Frame: Throughout study ]
    To compare the safety and toxicity of Genexol®-PM with those of Genexol®


Enrollment: 213
Actual Study Start Date: December 2008
Study Completion Date: November 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Genexol®-PM
This is a open-labeled, randomized, parallel, phase III Trial. Up to 106 elgible patients will be enrolled in each treatment arm(Total 212 subjects will recruited) according to the trial design. Patients will be randomly allocated to arm A (Genexol-PM) or arm B (Paclitaxel).
Drug: Genexol-PM®
Genexol-PM® 260mg/m2, intravenous infusion over 3 hours, every 3 weeks
Active Comparator: Genexol®
This is a open-labeled, randomized, parallel, phase III Trial. Up to 106 elgible patients will be enrolled in each treatment arm(Total 212 subjects will recruited) according to the trial design. Patients will be randomly allocated to arm A (Genexol-PM) or arm B (Paclitaxel).
Drug: Genexol®
Genexol® 175mg/m2, intravenous infusion over 3 hours, every 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

  1. Subjects who aged 18 years or older.
  2. Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial.
  3. Subjects who have histologically or cytologically confirmed breast cancer with evidence of recurrence or metastasis.
  4. 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.
  5. Subjects who have measurable disease in accordance with the RECIST criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876486

Locations
Korea, Republic of
National Cancer Center
Goyang-si, Gyeonggi-do, Korea, Republic of
Sponsors and Collaborators
Samyang Biopharmaceuticals Corporation
  More Information

Responsible Party: Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT00876486     History of Changes
Other Study ID Numbers: GPMBC301
Study First Received: April 3, 2009
Last Updated: April 27, 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 23, 2017