Can tighter blood pressure control shield hearts during breast cancer therapy?
NCT ID NCT06023576
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether a more aggressive approach to managing high blood pressure during breast cancer treatment can safely reduce the risk of heart damage. About 130 women with breast cancer who are receiving anthracycline chemotherapy will be randomly assigned to either intensive or standard blood pressure goals. The main goal is to see if intensive control lowers blood pressure more effectively over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- antihypertensive medications (ACE inhibitors, ARBs, beta-blockers, diuretics, etc.)
- What this could lead to
- If successful, this could show that aggressively managing blood pressure during breast cancer treatment lowers the risk of heart damage, leading to better long-term heart health for cancer patients.
- What could go wrong
- This is a small, early-phase trial (130 participants) testing a treatment strategy, not a new drug. The intensive approach may not prove more effective than standard care, and side effects from stronger blood pressure lowering are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 130 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2023
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 years * Female assigned at birth * Biopsy proven breast cancer (stage I-IV) * Treatment with therapy anthracycline-based chemo (with or without HER2-targeted therapy), with \>/= 2 cycles of anthracycline chemotherapy planned. * SBP ≥130 mm Hg * Willing and able to comply with the requirements of the protocol. * Participant must have and be willing to use their bluetooth enabled wifi or cellular mobile device * (For participants in the CPET cohort): Able to complete an acceptable baseline CPET, in the absence of high-risk ECG findings or other inappropriate response to exercise as determined by the PI, as defined by any of the following criteria: * Achieving a plateau oxygen consumption, concurrent with an increase in power output; * A respiratory exchange ratio ≥ 1.10; * Attainment of maximal predicted heart rate, as defined by a peak heart rate within 10bpm of the age predicted maximal heart rate (220 - Age\[years\]); * Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale. Exclusion Criteria: * eGFR \< 30 ml/min/1.73m2 (based upon Cockcroft-Gault, etc.) * Individuals with arm circumference too large to allow accurate BP measurement with available BP devices * Inability to accurately measure blood pressure in at least one arm (e.g., bilateral upper extremity lymphedema) * Cardiac comorbidity, including any of the following: * Acute coronary syndrome within 3 months prior to randomization. * Symptomatic heart failure (NYHA class III/IV) within past 6 months * History of stroke * Cardiac transplantation * Other medical disorder or condition that in the opinion of the investigator would impair the subject's ability to participate or adhere to study interventions * (For participants in the CPET cohort): Subjects must not have any of the following absolute contraindications to cardiopulmonary exercise testing: * Acute myocardial infarction (within 30 days of any planned study procedures), * Unstable angina * Uncontrolled arrhythmias causing symptoms or hemodynamic compromise, * Symptomatic severe aortic stenosis * Recurrent syncope * Active endocarditis * Acute myocarditis or pericarditis * Acute pulmonary embolus or pulmonary infarction (within 3 months of any planned study procedures) * Thrombosis of lower extremities (within 3 months of any planned study procedures) * Suspected dissecting aneurysm * Uncontrolled asthma * Pulmonary edema * Room air desaturation at rest ≤85% * Respiratory failure * Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis) * Mental impairment leading to inability to cooperate.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
RECRUITINGBasking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITINGNew York, New York, 10065, United States
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Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (Limited Protocol Activities)
RECRUITINGRockville Centre, New York, 11553, United States
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Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering Westchester (Limited Protocol Activities)
RECRUITINGHarrison, New York, 10604, United States
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