Actively Recruiting
Intensive Blood Pressure Control During Cardiotoxic Breast Cancer Treatment (PROTECT) A Randomized Controlled Trial
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
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive antihypertensive medications titrated to achieve specific systolic blood pressure goals during a 12-month cancer treatment period. Blood pressure management is supported by dietary and lifestyle recommendations. Participants will have seated blood pressure measurements guiding medication adjustments.
Visits every 4 weeks for the first 3 months, then every 3 months up to 12 months
Duration - Throughout the 12-month treatment period
Participants perform home blood pressure monitoring for 7 days at baseline, month 6, and month 12, and undergo echocardiograms at these same time points. Biomarker blood samples are collected at baseline, 3 months, and 6 months. Quality of life questionnaires are completed at baseline, 3 months, and 12 months. A subgroup of participants may complete cardiopulmonary exercise testing at baseline, 6 months, and 12 months.
Assessments at baseline, 3 months, 6 months, and 12 months; home monitoring for 7 days at baseline, 6 months, and 12 months
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
A
Anthony Yu, MD
J
Jennifer Liu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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