Lisinopril or Coreg CR® in Reducing Side Effects in Women With Breast Cancer Receiving Trastuzumab

Phase 2

Completed

Conditions: Breast Cancer
Cardiac Toxicity

Interventions: Drug: lisinopril
Drug: Coreg CR®
Other: placebo

Registration Number: NCT01009918

Lead Sponsor: University of South Florida

Brief Summary: RATIONALE: Lisinopril or Coreg CR®, may help reduce side effects caused by trastuzumab. It is not yet known whether lisinopril or Coreg CR® are more effective than a placebo in reducing side effects caused by trastuzumab.

PURPOSE: This phase II trial is studying lisinopril and Coreg CR® to see how well they work compared with a placebo in reducing side effects in patients with HER2-positive breast cancer receiving trastuzumab.

Detailed Description: OBJECTIVES:

Primary

* The primary objective of this study is to determine if administration of lisinopril or Coreg CR®, compared to placebo, will reduce the incidence of trastuzumab-induced cardiotoxicity, as measured by LVEF, in patients receiving adjuvant, or neoadjuvant,therapy for HER2 positive breast cancer.

Secondary

* To determine whether subjects randomized to active agent have fewer interruptions in trastuzumab therapy due to cardiomyopathy.

* To determine whether the treatment effect is consistent in anthracycline and nonanthracycline patient cohorts

* To compare changes in HRQL among the treatment groups during the study intervention

* To evaluate the long term effects on the prevention of cardiomyopathy and impact on HRQL for either or both study agents

* To compare the predictive value of troponin I and BNP in the identification of trastuzumab-induced cardiotoxicity

OUTLINE: This is a multicenter study. Patients are stratified according to chemotherapy comprising an anthracycline (yes vs no). Patients are randomized to 1 of 3 treatment arms.

* Arm I: Patients receive oral lisinopril once daily.

* Arm II: Patients receive oral Coreg CR® once daily.

* Arm III: Patients receive oral placebo once daily.

In all arms, study treatment begins with the first dose of trastuzumab and continues for up to 52 weeks or until the end of trastuzumab therapy.

Quality of life is assessed using the EORTC QLQ-C30 questionnaire at baseline, at 52 weeks (or at the end of trastuzumab therapy), and at 18 and 24 months (or 6 and 12 months after the completion of trastuzumab).

After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 468

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I lisinopril	lisinopril	Patients receive oral lisinopril once daily.
Arm II Coreg CR®	Coreg CR®	Patients receive oral Coreg CR® once daily.
Arm III placebo	placebo	Patients receive oral placebo once daily.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Trastuzumab-Induced Cardiotoxicity After 52 Weeks of Treatment	2 years	Reduction in incidence of trastuzumab-induced cardiotoxicity after 52 weeks of treatment as measured by preservation of Left Ventricular Ejection Fraction (LVEF). Number of Patients who experienced a cardiotoxicity.
Number of Participants With LVEF Decrease to <50%	2 years	Number of Participants with Left Ventricular Ejection Fraction (LVEF) drop to \<50%

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Trastuzumab Course Interruption	2 years	Measure indicates the number of patients who had an interruption of trastuzumab for any reason
Quality-of-life Changes Between Baseline and 52-weeks	52 weeks	Quality-of-life changes as assessed by North European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30), which measures the quality of life of cancer patients. Higher score indicates higher quality of life. Score range is 0-100. The questionnaire was administered at baseline and at 52 weeks.
Number of Participants With Cardiotoxicity-free Survival at 750 Days From Baseline	2 years	Number of Participants with cardiotoxicity-free survival at 750 days from baseline

Trial Locations

Locations (174): Todd Cancer Institute at Long Beach Memorial Medical Center
🇺🇸
Long Beach, California, United States
Olive View - UCLA Medical Center Foundation
🇺🇸
Sylmar, California, United States
Aurora Presbyterian Hospital
🇺🇸
Aurora, Colorado, United States
Boulder Community Hospital
🇺🇸
Boulder, Colorado, United States
Penrose Cancer Center at Penrose Hospital
🇺🇸
Colorado Springs, Colorado, United States
St. Anthony Central Hospital
🇺🇸
Denver, Colorado, United States
Porter Adventist Hospital
🇺🇸
Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center
🇺🇸
Denver, Colorado, United States
St. Joseph Hospital
🇺🇸
Denver, Colorado, United States
Rose Medical Center
🇺🇸
Denver, Colorado, United States
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Todd Cancer Institute at Long Beach Memorial Medical Center
🇺🇸Long Beach, California, United States