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

NCT00876486 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2017-05-01

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Genexol-PM®

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

DRUG

Genexol®

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

Sponsors & Collaborators

  • Samyang Biopharmaceuticals Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2013-02-28
Completion
2013-11-30

Countries

  • South Korea

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00876486 on ClinicalTrials.gov