Enalapril Maleate and Doxorubicin Hydrochloride in Treating Women With Breast Cancer

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masonic Cancer Center, University of Minnesota
• Treatments: Doxorubicin; Enalapril; Enalaprilat; Liposomal doxorubicin; Maleic acid

Criteria

Inclusion Criteria:

• Tissue diagnosis of a breast carcinoma

• The oncologist must have prescribed doxorubicin as part of the planned chemotherapy regimen

• Have acceptable organ function within 14 days of enrollment defined as:

• liver function: total bilirubin, AST and ALT within normal institutional limits

• kidney function: estimated Creatinine Clearance > 60 ml/min calculated creatinine clearance (for females) - formula: (140 - age) x weight x .85 divided by (sCr x 72)

• At least 18 years old

• Patient must have given written informed consent indicating an understanding of the investigational nature of the study

• Agrees not to consume grapefruit juice while on the study

Exclusion Criteria:

• Known allergy to enalapril

• Taking any known P450 cytochrome inducers or inhibitors

• Taking any herbal supplements while on the study or the week prior to receiving doxorubicin

• Taking an ace-inhibitor or angiotensin receptor blocker

• Pregnant or lactating. Enalapril is Pregnancy Categories C (first trimester) and D (second and third trimesters)