Status:
COMPLETED
GW572016 In Patients With Advanced Or Metastatic Breast Cancer
Lead Sponsor:
GlaxoSmithKline
Conditions:
Neoplasms, Breast
Eligibility:
FEMALE
20-40 years
Phase:
PHASE1
Brief Summary
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 overexpre...
Eligibility Criteria
Inclusion
- 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
- Patients with certain heart problems.
Key Trial Info
Start Date :
June 30 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2006
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00462956
Start Date
June 30 2004
End Date
December 20 2006
Last Update
August 31 2018
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Ehime, Japan, 791-0280
2
GSK Investigational Site
Fukuoka, Japan, 802-0077
3
GSK Investigational Site
Kanagawa, Japan, 241-0815
4
GSK Investigational Site
Saitama, Japan, 350-1298