Phase 3 Breast Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with breast cancer that has spread to other parts of the body (metastatic breast cancer)
• People who are starting or already receiving a HER2-targeted cancer treatment based on trastuzumab (such as Herceptin, a biosimilar, Kadcyla, or Enhertu), with or without chemotherapy or hormonal therapy, as long as it does not include a type of chemotherapy called anthracyclines
• People receiving this HER2-targeted treatment as their first, second, third, or fourth treatment for metastatic disease — including those whose cancer has spread to the brain
• People who are considered at increased risk of heart problems, meaning they have had previous anthracycline chemotherapy, OR have at least one of the following: a heart pumping function (LVEF) of 50–54% on echocardiogram, age 65 or older, a body mass index (BMI) of 30 or higher, current or past treatment for high blood pressure, a diagnosis of coronary artery disease, a diagnosis of diabetes, or a diagnosis of irregular heart rhythm (atrial fibrillation or flutter)
• People whose general health and ability to carry out daily activities falls within an acceptable range on a standard medical scale (Zubrod score of 0–2)
• People who have had a full physical examination and medical history review within the past 28 days
• People whose heart pumping function (LVEF) is 50% or higher on an echocardiogram performed within the past 28 days at an approved testing laboratory
• People whose liver function blood test results are within acceptable levels, tested within the past 28 days
• People who are willing to provide blood samples for the study
• People who have read about the investigational nature of the study and have signed a written consent form — or, where needed, whose legal representative has done so on their behalf

Who may not be able to join:

• People who are currently taking, have taken within the past 21 days, or plan to take a beta blocker, ACE inhibitor, or ARB (types of heart or blood pressure medications) — note: people already taking these medications may still be considered for a separate observational group (Arm 3) within the trial (confirm with trial site)
• People whose HER2-targeted treatment includes a type of chemotherapy called anthracyclines at the same time
• People who are receiving lapatinib as their only HER2-targeted therapy, without trastuzumab
• People who are dependent on dialysis for kidney function
• People who are pregnant or breastfeeding, due to potential risk to the baby — people who could become pregnant or father a child must agree to use effective contraception during the study
• People with a history of another cancer, unless it was an early-stage skin cancer, cervical cancer in situ, prostate cancer under monitoring, an early-stage cancer now in full remission, or any cancer from which the person has been cancer-free for at least five years

Important: Always verify eligibility with the trial site directly before applying.