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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00876486

Enrollment

213

Registered

2009-04-06

Start date

2008-12-31

Completion date

2013-11-30

Last updated

2017-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

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

Interventions

DRUGGenexol-PM®

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

DRUGGenexol®

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Objective Response Rate	6 months	Evaluate the efficacy of Genexol®-PM versus Genexol® in subjects with recurrent or metastatic breast cancer based on Objective Response Rate.

Secondary

Measure	Time frame	Description
Overall Survival, Progress Free Survival, Time to Tumor Progression, Duration of Overall Response	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	Throughout study	To compare the safety and toxicity of Genexol®-PM with those of Genexol®

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026