GW572016 In Patients With Advanced Or Metastatic Breast Cancer - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00462956

Purpose

This study is designed to evaluate the efficacy and safety of GW572016 in patients with refractory breast cancer and consists of two cohorts of patients. Patients in Cohort A must have ErbB2 overexpressing tumors while patients in Cohort B must have non-ErbB2 overexpressing tumors. Patients eligible for this study must have advanced metastatic breast cancer who have previously received treatment with anthracycline and taxane.

Condition	Intervention	Phase
Metastatic Breast Cancer	Drug: GW572106 oral tablets	Phase I

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Lapatinib Lapatinib Ditosylate Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Clinical Study of GW572016 in Patients With Advanced or Metastatic Breast Cancer

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

To evaluate tumor response rate in both cohort A (ErbB2 overexpressors) and in cohort B (ErbB2 non-overexpressor) population when treated with GW572016

Secondary Outcome Measures:

Clinical benefit Time to tumor response Length of response Time to progression of cancer 4 and 6 month progression free survival Overall survival as well as specific biomarkers in tumor tissue

Estimated Enrollment:	100
Study Start Date:	June 2004

Eligibility

Ages Eligible for Study:	20 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed advanced (IIIb or Stage IV) breast cancer who have progressed on prior anthracycline and taxanes containing regimens + trastuzumab for cohort A patients.
Patients must have adequate blood, liver, and kidney function and either be fully active or restricted only in performing strenuous activity.
Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.

Exclusion Criteria:

Patients with certain heart problems.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462956

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	EGF100642
Study First Received:	April 17, 2007
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00462956
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by GlaxoSmithKline:

metastatic breast cancer
Stage IV breast cancer
trastuzumab (Herceptin)

lapatinib
ErbB1
ErbB2

Study placed in the following topic categories:

Skin Diseases
Trastuzumab
Breast Neoplasms
Lapatinib
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009