Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

LVEF assessment at baseline, 6 months, and 12 months

Left Ventricular Ejection Fraction

Anthony Yu, MD

The purpose of this study is to test whether patients with breast cancer who are being treated with non-anthracycline trastuzumab therapy can safely be monitored for heart related side effects less often than usual.

A Study of Limited Heart Monitoring During Non-anthracycline Trastuzumab-based Therapy in Breast Cancer Patients

A Safety and Feasibility Study of Limited Cardiac Monitoring During Non-anthracycline Trastuzumab-based Therapy in Patients With HER2-positive Breast Cancer

• Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Participants have HER2-positive breast cancer treated with non-anthracycline trastuzumab-based therapy.

Memorial Sloan Kettering Cancer Center

Heart and Blood Diseases

Heart Failure

Ventricular Dysfunction, Left

Ventricular Dysfunction

Heart Diseases

Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30. Electrocardiogram performed at baseline. Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30. Telephone follow-up by study staff at months 3 and 5.

Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.

Echocardiograms

Electrocardiogram

Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.

Symptom Questionnaire

Telephone follow-up by study staff at months 3 and 5.

Telephone Follow-Up

Anecita Fadol, PHD, MSN

The goal of this clinical trial is to learn if heart function remains normal after stopping heart failure medication in patients who have received chemotherapy.

If you agree to take part in this study, the following baseline tests and procedures will be performed on Day 1:

* Your complete medical history will be recorded.
* You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, and breathing rate).
* You will complete a questionnaire about any symptoms you may be having. The questionnaire should take about 5-10 minutes to complete.
* You will have an echocardiogram (ECHO) and an electrocardiogram (ECG) to check your heart function.
* You will have blood (about 3 tablespoons) drawn for routine tests. If you can become pregnant, part of this blood draw will be used for a pregnancy test. To take part in this study, you must not be pregnant.
* You will be given instructions on how to gradually wean yourself off of your heart failure medication.
* You will be given a machine that you will use to measure your blood pressure at home.

You will be asked to monitor your blood pressure and heart rate at home daily and keep the results in a diary. You should bring your diary to each study visit.

At Month 1:

* You will have a physical exam, including measurement of your vital signs.
* You will complete the questionnaire about any symptoms you may be having.
* You will have blood (about 2 teaspoons) drawn for routine tests.

At Months 2, 4, 6, 12, 18, and 30:

* You will have a physical exam, including measurement of your vital signs.
* You will complete the questionnaire about any symptoms you may be having.
* You will have an ECHO.
* You will have blood (about 2 teaspoons) drawn for routine tests.

At Months 3 and 5, you will have a telephone follow-up with a member of the research team.

Length of Study Participation:

You may continue taking part in the study for up to 6 continuous months with follow-up visits at Months 12, 18, and 30. You will no longer be able to take part if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

This is an investigational study.

Up to 45 participants will be enrolled in this study. All will take part at MD Anderson.

REcovery of Left Ventricular Dysfunction in CAncer Patients (RECAP Trial)

A withdrawal failure is defined as a decrease in the LVEF when cardiac medications are discontinued as determined by echocardiogram to LVEF\<50% or a decrease by 10% from baseline measurement. Maintenance of LVEF is defined as LVEF≥50%. LVEF was assessed at Baseline, Months 2, 4, 6, 12, 18, \& 30.

To identify an increased troponin-I that can predict the possibility of HF medication withdrawal failure.

M.D. Anderson Cancer Center

Weaning of Cardiac Medications Based on Therapeutic Category (i.e. Beta Blockers, ACE-I, ARB, or any combination of these medications.)

Intervention (Weaning)

Down titrated current dose by half each week until medication is off. Weaning order: ACE-I, ARB, and beta blocker.

Maintenance of LVEF ≥50% after weaning of heart failure medications.

Age, Categorical

Age, Continuous

< 30

>/= 30-39

>/= 40-49

>/= 50-59

>/= 60

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

LVEF ≥50%, taking heart failure medications classified as Angiotension converting enzyme inhibitors (ACE-Inhibitors), Beta-blockers, and/or angiotension-receptor blockers (ARBs), no diabetes, no hypertension, no arrhythmias, cancer in remission for at least 6 months

Left ventricular ejection fraction (LVEF) ≥50%

Patients at MD Anderson that met inclusion criteria (specified in Recruitment Details) and not excluded due to: Cancer recurrence; documented history of hypertension, coronary artery disease, myocardial infarction, diabetes mellitus, amyloidosis or hemochromatosis; presence of HF symptoms (e.g. shortness of breath, edema); Pregnancy.

Dr. Anecita P. Fadol,PHD/Associate Professor, Department of Nursing

Maintained (LVEF </= 50%)

Withdrawal Failure (LVEF <50% or decrease of 10%)

Lost to Follow Up

Withdrawal by Subject

"Weaning of Cardiac Medications Based on Therapeutic Category (i.e. Beta Blockers, ACE-I, ARB, or any combination of these medications.)"

Determine the Percentage of Cancer Survivors That Maintain Left Ventricular Ejection Fraction (LVEF) ≥50% After Discontinuing Cardiac Medications: Beta Blockers, Angiotensin Converting Enzyme Inhibitors (ACE-I), or Angiotensin Receptor Blockers (ARB).

The standard deviation is 0 because every value collected over the course of the entire study was 0.03. Mean would be 0.03 with a standard deviation of 0

Risk Factors to Predict Early Decline of Myocardial Function During the Weaning of HF (Heart Failure) Medications.

Overall Study

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Cardiotoxicity

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Other Dietary Supplements

Carnitine

Patients will be randomized to L-carnitine therapy or placebo. Patients in the treatment group will receive oral L-carnitine (3 grams daily) for 3 days prior to chemotherapy, 1 gram of intravenous L-carnitine (5 cc over 5 minutes, prior to chemotherapy) on the day of chemotherapy and oral L-carnitine (3 grams daily) for 3 days after chemotherapy.

L-carnitine

Benjamin JW Chow, MD, FRCPC

Rob S Beanlands, MD, FRCPC

Haissam Haddad, MD, FRCPC

George Wells, M.Sc., PhD

Susan Dent, MD, FRCPC

Sean Hopkins, B.Sc, RPEBC

Michele A Turek, MD, FRCPC

Breast cancer is very common and afflicts 1 in 9 North American women. The treatment of breast cancer often requires the use of chemotherapy including "anthracyclines". Anthracyclines can damage the heart resulting in heart failure and even death. Clinicians and researchers are continually seeking methods that will reduce the toxic effects of anthracycline treatment.

L-carnitine is a substance that is produced naturally in the body and is required for normal heart function. Animal studies have suggested that L-carnitine protects the heart from the effects of anthracyclines, however this has not been verified in humans.

This study will assess the potential role of L-carnitine in the prevention of anthracycline induced heart damage. The investigators will enroll 144 patients into this study. Patients will be randomly assigned to L-carnitine therapy or to standard care (no L-carnitine therapy). Patients in the L-carnitine group will receive oral and intravenous L-carnitine prior to and after their anthracycline therapy. Patients will undergo regular follow up and testing to assess heart function. The investigators believe that patients treated with L-carnitine will benefit and have fewer complications associated with anthracycline treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Limited Heart Monitoring During Non-anthracycline Trastuzumab-based Therapy in Breast Cancer Patients	NCT03983382	Breast Cancer	Left Ventricula...	18 Years -	Memorial Sloan Kettering Cancer Center
REcovery of Left Ventricular Dysfunction in CAncer Patients (RECAP Trial)	NCT02543294	Heart Failure Cancer Treatmen...	Echocardiograms Electrocardiogr... Symptom Questio... Telephone Follo...	18 Years -	M.D. Anderson Cancer Center
Ability of L-carnitine to Prevent Heart Damage in Breast Cancer Patients Receiving Anthracycline Chemotherapy	NCT00247975	Heart Failure	L-carnitine	18 Years -	Ottawa Heart Institute Research Corporation

Spots Global Cancer Trial Database for left ventricular ejection fraction