Breast Cancer Clinical Trial
Official title:
The Effect of Enalapril on Doxorubicin Exposure in Adjuvant Breast Cancer Treatment
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Enalapril maleate may help protect heart cells from the side effects of
chemotherapy. It is not yet known whether giving enalapril maleate before or after
doxorubicin hydrochloride is more effective in treating women with breast cancer.
PURPOSE: This randomized clinical trial is studying giving enalapril maleate together with
doxorubicin hydrochloride to see how well it works in treating women with breast cancer.
This study is a drug interaction study designed to study the effects of enalapril on doxorubicin metabolism. Women with breast cancer for whom at least two cycles every 14 day doxorubicin is planned will be considered for enrollment. Study participation will be for 2 treatment cycles of doxorubicin or approximately 4 weeks. Patients will receive a 14 day course of daily enalapril in association with one cycle of doxorubicin and receive no study agent during the other cycle allowing patients to act as their own control. The sequence of enalapril dosing will be assigned by randomization at study enrollment. Blood samples for pharmacokinetics will be drawn before and at 7 time points after each of the two doses of doxorubicin. For each patient, serum doxorubicin and doxorubicinol concentrations both on and off of enalapril will be compared. ;
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