Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Heart and Blood Diseases

Substance Related Disorders

Wounds and Injuries

Rare Diseases

Recurrence

Breast Neoplasms

Cardiotoxicity

Breast Neoplasms, Male

Breast Diseases

Skin Diseases

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Breast Cancer, Male

Antineoplastic Agents

All Drugs and Chemicals

Antihypertensive Agents

Channel Blockers

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Cardiotonic Agents

Bone Density Conservation Agents

Anti-Infective Agents

Trastuzumab

Carvedilol

Lisinopril

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Adrenergic Agents

Adrenergic Antagonists

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Calcium Channel Blockers

Calcium, Dietary

Hormones

Adrenergic alpha-1 Receptor Antagonists

Adrenergic alpha-Antagonists

Enzyme Inhibitors

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HIV Protease Inhibitors

Protease Inhibitors

Patients receive oral lisinopril once daily.

Patients receive oral Coreg CR® once daily.

Patients receive oral placebo once daily.

Coreg CR®

lisinopril

placebo

Maya Guglin, MD, PhD

Pamela N. Munster, MD

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.

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.

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

Phase II Placebo-controlled Trial of Lisinopril and Coreg CR® to Reduce Cardiotoxicity in Patients With Breast Cancer Receiving (Neo)Adjuvant Chemotherapy With Trastuzumab (Herceptin®)

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 Left Ventricular Ejection Fraction (LVEF) drop to \<50%

Measure indicates the number of patients who had an interruption of trastuzumab for any reason

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

National Cancer Institute (NCI)

University of South Florida

Adverse Events were collected from patient at each study visit.

Patients receive oral lisinopril once daily.

lisinopril: Given orally

Arm I Lisinopril

Patients receive oral Coreg CR® once daily.

Coreg CR®: Given orally

Arm II Coreg CR®

Patients receive oral placebo once daily.

placebo: Given orally

Arm III Placebo

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Did not have information for 4 participants

Body Mass Index (BMI)

Number of participants who experienced cardiotoxicity

Number of Participants With Trastuzumab-Induced Cardiotoxicity After 52 Weeks of Treatment

Number of Participants With LVEF Decrease to <50%

Number of patients who had an interruption of trastuzumab for any reason

Number of Patients With Trastuzumab Course Interruption

Mean change from baseline to 52-week endpoint

Spots Global Cancer Trial Database for coreg cr®

Every month we try and update this database with for coreg cr® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for coreg cr®

Every month we try and update this database with for coreg cr® cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for coreg cr® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.