A Study of Blood Pressure Control During Cancer Treatment

NCT06023576 | Recruiting Phase 2

• 1 other identifier: 23-159
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 7

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

Keywords

Blood pressure; 23-159

Outcome Measures

Primary Outcomes (1)

• mean change in systolic blood pressure (SBP) from baseline to 12 months

  based upon in-office measurement

  12 months

Study Arms (2)

standard-of-care antihypertensive medications

EXPERIMENTAL

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.

Other: antihypertensive medications; Diagnostic Test: Blood pressure measurement; Diagnostic Test: Echocardiogram; Other: Symptom-limited cardiopulmonary exercise test; Other: Quality of Life Measures; Diagnostic Test: Biomarkers

higher dose antihypertensive medications

EXPERIMENTAL

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.

Other: antihypertensive medications; Diagnostic Test: Blood pressure measurement; Diagnostic Test: Echocardiogram; Other: Symptom-limited cardiopulmonary exercise test; Other: Quality of Life Measures; Diagnostic Test: Biomarkers

Interventions

antihypertensive medications OTHER

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

higher dose antihypertensive medications; standard-of-care antihypertensive medications

Blood pressure measurement DIAGNOSTIC_TEST

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).

higher dose antihypertensive medications; standard-of-care antihypertensive medications

Echocardiogram DIAGNOSTIC_TEST

At baseline, month 6, and month 12

higher dose antihypertensive medications; standard-of-care antihypertensive medications

Quality of Life Measures OTHER

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.

higher dose antihypertensive medications; standard-of-care antihypertensive medications

Biomarkers DIAGNOSTIC_TEST

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

higher dose antihypertensive medications; standard-of-care antihypertensive medications

Symptom-limited cardiopulmonary exercise test OTHER

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.

higher dose antihypertensive medications; standard-of-care antihypertensive medications

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female assigned at birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Rockville Centre, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Cardiotoxicity

Interventions

Blood Pressure Determination; Echocardiography; Environmental Biomarkers

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Physical Examination; Cardiac Imaging Techniques; Diagnostic Imaging; Ultrasonography; Heart Function Tests; Biomarkers; Biological Factors; Biological Phenomena; Environmental Monitoring; Environmental Exposure; Environmental Pollution; Public Health; Environment and Public Health

Study Officials

• Anthony Yu, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony Yu, MD

CONTACT

212-639-7932; yua3@mskcc.org

Jennifer Liu, MD

CONTACT

212-639-8220

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This open-label, two-arm RCT will compare the effects of intensive versus standard SBP control in patients with BC and HTN receiving anthracycline-based treatment (with or without HER2-targeted therapy).

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: September 5, 2023
• Study Start: August 18, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 30, 2028
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (7)