A Study to Reduce Cardiomyopathy in Breast Cancer Patients Being Treated With Trastuzumab
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-008495
Sponsor Protocol Number: 17-008495
About this study
The purpose of this study is to evaluate different strategies of cardiovascular therapy with carvedilol aiming to reduce the incidence of heart function declines and heart failure in at-risk breast cancer patients while on trastuzumab therapy.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- ≥18 years of age,
- New diagnosis of HER2+ breast cancer,
- Planned adjuvant (post-surgery) HER2-directed therapy,
- And meeting either criteria #2 or #3 below for cardiac dysfunction risk. The latter is defined in the 2017 clinical practice guidelines on the prevention and monitoring of cardiac dysfunction in cancer patients by American Society of Clinical Oncology (ASCO).41 Three groups of cancer patients are deemed to be at risk of cardiac dysfunction and HF:
- Any patient receiving high-dose anthracycline (e.g., doxorubicin ≥ 250 mg/m2), high-dose radiotherapy (RT ≥ 30 Gy) where the heart is in the treatment field, or lower-dose anthracycline in combination with lower-dose RT, where the heart is in the treatment field,
- Treatment with lower-dose anthracycline or trastuzumab alone with any of the following risk factors:
- ≥2 cardiovascular risk factors, including smoking, hypertension, diabetes, dyslipidemia, and obesity, age ≥60 years, compromised cardiac function (e.g. history of myocardial infarction, ≥ moderate valvular heart disease),
- Treatment with lower-dose anthracycline followed by trastuzumab (sequential therapy).
Exclusion Criteria:
- History of HF of any class and type, or diagnosis of cardiomyopathy in the past,
- LVEF <53% at screening,
- Baseline use of cardvedilol, nebivolol or bisoprolol,
- Current ACE inhibitor or ABR therapy for hypertension in the presence of diabetes and/or for chronic kidney disease/proteinuria,
- Intolerance to beta-blocker,
- Current anti-arrhythmic drug therapy,
- History of bronchial asthma or related bronchospastic conditions,
- Heart rate < 50 BPM at screening,
- History of or current sick sinus syndrome,
- AV block grade II or higher (unless patient has a permanent pacemaker) at screening,
- Systolic blood pressure < 90 mmHg at screening,
- Severe hepatic dysfunction, as defined by NCI ODWG (total bilirubin >3x ULN, any AST elevation) or Child Pugh C class
- Pregnancy,
- Inability to provide informed consent.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Joerg Herrmann, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available