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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00876486
• Other study ID #: GPMBC301
• Status: Completed
• Phase: Phase 3
• First received: April 3, 2009
• Last updated: April 27, 2017
• Start date: December 2008
• Est. completion date: November 2013

Study information

• Verified date: April 2017
• Source: Samyang Biopharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: November 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Genexol-PM®
Genexol-PM® 260mg/m2, intravenous infusion over 3 hours, every 3 weeks
• Genexol®
Genexol® 175mg/m2, intravenous infusion over 3 hours, every 3 weeks

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang-si, Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Samyang Biopharmaceuticals Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	Evaluate the efficacy of Genexol®-PM versus Genexol® in subjects with recurrent or metastatic breast cancer based on Objective Response Rate.	6 months
Secondary	Overall Survival, Progress Free Survival, Time to Tumor Progression, Duration of Overall Response	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.	Event driven
Secondary	Safety and toxicity	To compare the safety and toxicity of Genexol®-PM with those of Genexol®	Throughout study