Phase I/II Clinical Study of GW572016 (Lapatinib Ditosylate Monohydrate) in Combination With Trastuzumab in Patients With Breast Cancer Previously Treated With Trastuzumab
- 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.
- Patients with certain heart problems.
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Optimal doses and toleration of the two drugs administered together Tumor progression measured by radiological imaging 4-8 weekly
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:
GSK Clinical Trials
Japan: Ministry of Health, Labor and Welfare
- Neoplasms, Breast
- Stage IV breast cancer
- breast cancer
- Breast Neoplasms