Trials / Completed
CompletedNCT00876486
Evaluate the Efficacy and Safety of Genexol®-PM Compared to Genexol® in Recurrent or Metastatic Breast Cancer
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 213 (actual)
- Sponsor
- Samyang Biopharmaceuticals Corporation · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2008-12-01
- Primary completion
- 2013-02-01
- Completion
- 2013-11-01
- First posted
- 2009-04-06
- Last updated
- 2017-05-01
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT00876486. Inclusion in this directory is not an endorsement.