This trial looks at two groups of patients with HER-2 positive breast cancer that has spread. All participants are receiving treatment with trastuzumab, a medicine that targets HER-2. The main goal is to see how common heart problems are in patients taking certain heart medications along with their cancer treatment. The larger group is observed without any new treatment, while a smaller group is given a heart medicine called carvedilol to see if it helps prevent heart issues from chemotherapy.
The trial's ID number is NCT03418961. It is a Phase 3 study, meaning it is looking at how well the treatment works and its safety. The study is regulated by the FDA and aims to include about 491 participants.
Who can join
Adults aged 18 and older can join, including both men and women. Participants must have HER-2 positive breast cancer that has spread and be starting or continuing trastuzumab-based treatment. They must also be at risk for heart problems. Some heart medications must not be taken before joining. The trial team will confirm each person's eligibility before they can participate.
Conditions
Cardiotoxicity, HER2/Neu Positive, Metastatic Malignant Neoplasm in the Brain, Recurrent Breast Carcinoma, Stage IV Breast Cancer AJCC v6 and v7
Age group
Adult, Older adult
Sex
All sexes
The study team makes the final call on eligibility.
What happens in the study
Participants are divided into three groups. The first group receives carvedilol, taken twice a day, for up to 108 weeks. The second group receives no extra treatment for up to 108 weeks. The third group is observed without any new medications for the same time period. Everyone's heart health is monitored throughout the trial.
Where
This trial is enrolling at 577 locations. Recruiting sites are listed first.
Abbott-Northwestern Hospital
Minneapolis, Minnesota
Recruiting
Ascension Providence Hospitals - Southfield
Southfield, Michigan
Recruiting
Augusta Health Center for Cancer and Blood Disorders
Fishersville, Virginia
Recruiting
Aultman Health Foundation
Canton, Ohio
Recruiting
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi
Recruiting
Baptist Memorial Hospital and Cancer Center-Memphis
Medical OncologistMedical Oncologist · New York, NY · New York · NY
Director of the Breast Cancer Center at NYU Langone’s Perlmutter Cancer Center. Treats breast cancer. Based in New York. The main cancer doctor for adults. Manages your treatment and your care team. Recognized at state, national or international level. Chosen on merit.
Inaugural Jeffrey F. Moley Professor of Endocrine and Oncologic Surgery, WashU. Treats breast cancer. Works as a surgical oncologist. Based in St. Louis, Missouri. Chosen on merit.
Microsurgical breast reconstruction specialist, MSK. Treats breast cancer and mouth cancer. Offers microsurgical breast reconstruction, head and neck reconstruction and abdominal wall reconstruction. Works as a plastic & reconstructive surgeon. Based in New York. Chosen on merit.