Breast Cancer Clinical Trial
Official title:
A Phase 1/2 Study Of HKI-272 In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer
The purpose of this study is to identify the highest tolerable dose of neratinib (HKI-272) in
combination with vinorelbine and to assess the safety of the combination of the two drugs as
well as to obtain preliminary information on whether the combination of the two drugs has any
effect on solid tumors.
The study will be conducted in two parts. In the first part, testing will be done on up to 12
subjects to determine the highest tolerable dose of HKI-272 and vinorelbine in patients with
advanced solid tumors. In the second part of the study, approximately 60 additional subjects
with metastatic ErbB-2-positive breast cancer, with no prior exposure to lapatinib, are
planned to be added to better define the tolerability and preliminary activity of HKI-272 in
combination with vinorelbine. Up to 20 additional subjects with ErbB-2-positive breast cancer
with prior lapatinib exposure are also planned to be enrolled in part 2 for exploratory
analyses.
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