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

This study is currently recruiting participants.

Verified by Samyang, April 2009

First Received: April 3, 2009 No Changes Posted

Sponsored by:	Samyang
Information provided by:	Samyang
ClinicalTrials.gov Identifier:	NCT00876486

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 (paclitaxel-loaded polymeric micelle)	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel

Study Type:

Interventional

Further study details as provided by Samyang:

Study Start Date:

December 2008

Eligibility

Criteria

Inclusion Criteria:

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

Subjects who aged 18 years or older.
Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial.
Subjects who have histologically or cytologically confirmed breast cancer with evidence of recurrence or metastasis.
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.
Subjects who have measurable disease in accordance with the RECIST criteria

Contacts and Locations

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

Locations

Korea, Republic of
National Cancer Center	Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of
Contact: Sunwoo Park 82-31-920-1228 ext 1228 sophie486@lycos.co.kr
Principal Investigator: Jungsil Ro, MD,PhD

Sponsors and Collaborators

Samyang

More Information

No publications provided

Study ID Numbers:	GPMBC301
Study First Received:	April 3, 2009
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00876486 History of Changes
Health Authority:	Korea: Food and Drug Administration

Study placed in the following topic categories:

Skin Diseases
Paclitaxel
Breast Neoplasms
Breast Diseases
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009