Clin2
NCT03418961Possibly a fitRecruiting

Study of heart-risk management for metastatic HER2 breast cancer

CardiotoxicityHER2/Neu PositiveMetastatic Malignant Neoplasm in the BrainRecurrent Breast CarcinomaStage IV Breast Cancer AJCC v6 and v7

Treatments studied

Part of Brain & nervous system, Cancer, Heart & circulation, Injuries & trauma, Skin clinical trials.

This trial follows people with metastatic HER2-positive breast cancer who are at higher risk for heart damage while on HER2-targeted therapy. Some participants are randomly assigned to different monitoring/heart-protection approaches to see what best helps keep the heart safe.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 3
Enrollment
491 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You have metastatic (stage IV) HER2-positive breast cancer
  • You are starting or continuing HER2-targeted treatment (often trastuzumab-based), without taking chemotherapy that includes anthracyclines at the same time
  • Your HER2-targeted treatment is planned for the 1st, 2nd, 3rd, or 4th line for metastatic disease
  • You have higher heart-risk, such as past anthracycline treatment or risk factors like age 65+, diabetes, coronary artery disease, atrial fibrillation, high BMI, or certain blood-pressure medicines
  • Your heart pumping function (LVEF) must be at least 50% on an ultrasound/echocardiogram within 28 days
  • You must be able to have follow-up heart ultrasound tests and share blood samples for research

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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