Breast Cancer Clinical Trial
Official title:
A Phase IB Study of Crizotinib (XALKORI) and Sunitinib (SUTENT) in Metastatic Breast Cancer
This is a Phase 1 Trial. Crizotinib is a medication that is taken by mouth. It has shown that
it can help slow down or stop the growth of tumor cells. The marketing name of the drug is
"Xalkori". It has been approved by the FDA (Food and Drug Administration) to treat other
types of metastatic cancer, but the investigators believe it may be helpful to treat breast
cancer as well.
Sunitinib is the other medication used in the study. It is also taken by mouth in the form of
a capsule. The marketing name of this drug is "Sutent". It too has been approved by the FDA
to treat other types of cancer, but not for breast cancer.
In this study the investigators will be combining both of these two treatments, but at
different doses.
One third of the patients will take Crizotinib 200 mg, twice daily with Sunitinib 25.0 mg
once a day.
One third of the patients will take Crizotinib 250 mg, twice daily with Sunitinib 25.0 mg
once a day, and One third of the patients will take Crizotinib 250 mg, twice daily with
Sunitinib 37.5 mg once a day.
This study will determine the safety and tolerability of the combination of crizotinib and sunitinib in the treatment of Metastatic Breast Cancer and help to establish the maximum tolerated dose for future phase II studies of the combination. ;
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