Recruiting

Phase 2

Blood Pressure ControlA Study of Blood Pressure Control During Cancer Treatment

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06023576

Conditions

Breast Cancer

Cardiotoxicity

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

antihypertensive medications

Blood pressure measurement

Echocardiogram

Symptom-limited cardiopulmonary exercise test

Quality of Life Measures

Study Details

Brief summary:

The purpose of this study to find out whether an intensive approach to treating high blood pressure during breast cancer treatment is safe and more effective than standard blood pressure treatment at lowering blood pressure levels and the risk of cardiotoxicity in patients with cancer. Other studies have shown lowering blood pressure improves the health of patients. However, these studies have not included people with cancer.

The PROTECT trial is testing a treatment strategy regarding intensive versus standard SBP goals, and is not testing specific medications.

Conditions

Breast Cancer

Cardiotoxicity

Study ID

NCT06023576

Start date

Aug 18, 2023

Status verified date

May, 2026

Completion date

May 30, 2029

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: standard-of-care antihypertensive medications

SBP control will consist of treatment with antihypertensive medications titrated every 4 weeks for the first 3 months, and then every 3 months in months 4-12. SBP control will be achieved by titration of antihypertensive medications based upon a standardized algorithm and will be implemented during a 12-month study period. At the time of randomization, no antihypertensive treatments may be initiated or modified if SBP is ≥160 mm Hg. The clinical context may be considered at each visit to inform decision-making regarding treatment initiation or modification, at the discretion of the treating provider.

experimental: higher dose antihypertensive medications

Patients randomized to intensive SBP control will be treated to achieve an SBP goal <120 mm Hg, and patients randomized to standard SBP control will be treated to achieve an SBP goal <140 mm Hg. Antihypertensive medications will be titrated on the basis of seated blood pressure measurements obtained after a 5-min rest period. All participants will be provided with dietary (e.g., 1500mg/d sodium restriction) and lifestyle recommendations as background therapy for optimizing HTN control.The clinical context may be considered at each visit to inform decision-making regarding treatment initiation or modification, at the discretion of the treating provider.

Interventions

antihypertensive medications

One or more of the following medications may be used in both randomization groups to achieve SBP goals:

Angiotensin converting enzyme inhibitors (ACEI)
Angiotensin receptor blockers (ARBs)
Beta-blockers (BB)
Thiazide-type diuretics
Calcium channel blockers
Aldosterone antagonists
Alpha1-receptor blockers.
Direct vasodilators
Loop diuretics

Blood pressure measurement

Home BP Monitoring (HBPM)-Throughout the study period, patients will perform HBPM at baseline, month 6, and month 12 (end of treatment). At each of these timepoints, HBPM will be performed for 7 days with 2 morning and 2 evening readings for each day (measured 1-min part).

Echocardiogram

At baseline, month 6, and month 12

Symptom-limited cardiopulmonary exercise test

Consecutive patients in each treatment group who meet the eligibility criteria for exercise testing will be offered to participate in CPET at the time of consent. Patients who agree will undergo CPET (baseline, 6 months, and 12 months) until the target accrual of 33 patients per group is met.

Quality of Life Measures

FACT-B, Fatigue Symptom Inventory (FSI), Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale, Godin Leisure Time Exercise Questionnaire (GLTEQ),PROMIS Medication Adherence Scale. Given baseline, 3 months and 12 months.

Biomarkers

Research blood samples will be collected at baseline, 3 months, and 6 months

Primary outcome measure

mean change in systolic blood pressure (SBP) from baseline to 12 months [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Anthony Yu, MD

212-639-7932 yua3@mskcc.org

Jennifer Liu, MD

212-639-8220

Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Anthony Yu, MD

212-639-7932

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Anthony Yu, MD

212-639-7932

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Anthony Yu, MD

212-639-7932

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Anthony Yu, MD

212-639-7932

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Anthony Yu, MD

212-639-7932

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Anthony Yu, MD

212-639-7932

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Anthony Yu, MD

212-639-7932

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

Blood pressure
23-159

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-05-14.