Actively Recruiting
Study of Intensive vs Standard Blood Pressure Control During Breast Cancer Treatment to Reduce Heart Risks
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-14
130
Participants Needed
7
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether an intensive approach to controlling high blood pressure is safe and more effective than standard treatment in lowering blood pressure and reducing the risk of heart damage during breast cancer treatment. This trial focuses on patients with breast cancer undergoing treatment with anthracycline-based chemotherapy and compares two systolic blood pressure SBP goals without testing specific medications. Participants are randomly assigned to one of two groups one aiming for intensive blood pressure control with an SBP goal below 120 mm Hg, and the other aiming for standard control with an SBP goal below 140 mm Hg. Antihypertensive medications, including various types such as ACE inhibitors, beta-blockers, diuretics, and others, will be adjusted every 4 weeks for the first 3 months and then every 3 months up to 12 months. All participants receive dietary and lifestyle advice to help manage blood pressure. During the study, participants will have their blood pressure monitored at home and in clinic visits, along with echocardiograms at baseline, 6 months, and 12 months to assess heart function. Some participants may undergo cardiopulmonary exercise tests. Quality of life questionnaires and blood samples for biomarker analysis will also be collected. The main outcome measured is the change in systolic blood pressure from the start of the study to 12 months. The study lasts for one year, with regular follow-ups to evaluate treatment effects and safety.
CONDITIONS
Brief Title
A Study of Blood Pressure Control During Cancer Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Female assigned at birth
- Biopsy-proven breast cancer (stage I-IV)
- Planned treatment with at least 2 cycles of anthracycline-based chemotherapy, with or without HER2-targeted therapy
- Systolic blood pressure of 130 mm Hg or higher
- Willing and able to follow the study protocol
- Has and is willing to use a Bluetooth-enabled mobile device with Wi-Fi or cellular connection
- For CPET subgroup: able to complete baseline cardiopulmonary exercise test without high-risk findings
You will not qualify if you...
- Estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73m2
- Arm circumference too large for accurate blood pressure measurement with available devices
- Unable to measure blood pressure accurately in at least one arm (e.g., due to bilateral lymphedema)
- Recent cardiac conditions including acute coronary syndrome within 3 months, symptomatic heart failure (NYHA class III/IV) within 6 months, history of stroke, or cardiac transplantation
- Other medical conditions that would impair participation or adherence to interventions
- For CPET subgroup: absolute contraindications to exercise testing, including recent heart attack, unstable angina, uncontrolled arrhythmias, severe aortic stenosis, recurrent fainting, active infections affecting heart or lungs, pulmonary embolism, thrombosis, respiratory failure, uncontrolled asthma, mental impairment preventing cooperation, and others as specified in the protocol
Research Team
A
Anthony Yu, MD
J
Jennifer Liu, MD
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