Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
This is a phase l/II study. The purpose of this study is to test the safety of the study drug
neratinib in combination with a standard chemotherapy drug called capecitabine at different
doses to find out what effects, if any, it has on people. Capecitabine (Xeloda®) is approved
by the Food and Drug Administration (FDA) for advanced breast cancer treatment. Neratinib is
an investigational drug, meaning the FDA has not approved the use of this drug for advanced
breast cancer. The combination of capecitabine and neratinib has been studied before in
another study where capecitabine was administered using the standard dosing schedule. In this
study, the investigators want to find out if a different dosing schedule of capecitabine
combined with neratinib is safer. This different dosing schedule is experimental, meaning the
administration schedule of capecitabine and neratinib is not FDA approved for treatment for
HER2 positive advanced breast cancer.