Trial Information
Phase I/II Clinical Study of GW572016 (Lapatinib Ditosylate Monohydrate) in Combination With Trastuzumab in Patients With Breast Cancer Previously Treated With Trastuzumab
Inclusion Criteria
Inclusion criteria:
- Patients with confirmed breast cancer who have received prior trastuzumab.
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Optimal doses and toleration of the two drugs administered together Tumor progression measured by radiological imaging 4-8 weekly
Outcome Description:
To confirm the safety and tolerability of the recommended dose of lapatinib in combination with trastuzumab which was determined in a preceding overseas study, and to determine the recommended dose in Japan.
Outcome Time Frame:
6 Months
Safety Issue:
No
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
EGF105635
NCT ID:
NCT00371488
Start Date:
April 2006
Completion Date:
December 2007
Related Keywords:
- Neoplasms, Breast
- ErbB2
- Stage IV breast cancer
- ErbB1
- breast cancer
- lapatinib
- Herceptin
- trastuzumab
- Breast Neoplasms
- Neoplasms