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The Effect of Enalapril on Doxorubicin Exposure in Adjuvant Breast Cancer Treatment

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

The Effect of Enalapril on Doxorubicin Exposure in Adjuvant Breast Cancer Treatment

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.

Inclusion Criteria:

- Tissue diagnosis of a breast carcinoma

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

- 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

- Taking an ace-inhibitor or angiotensin receptor blocker

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Increase or decrease in doxorubicin hydrochloride exposure

Outcome Description:

Doxorubicin plasma concentration (DPC) will be the primary pharmacokinetic (PK) measure of the exposure. Each patient will have PK performed twice - once with enalapril and once without enalapril. An increase of more than 115 ng/ml in DPC will be considered important.

Outcome Time Frame:

Before and After Receiving Enalapril

Safety Issue:


Principal Investigator

Anne H. Blaes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

April 2009

Completion Date:

December 2012

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • Breast Neoplasms



Fairview Southdale Hospital Edina, Minnesota  55435
University of Minnesota Children's Hospital - Fairview Minneapolis, Minnesota  55455