Breast CancerPhase 2NCT06023576
A Study of Blood Pressure Control During Cancer Treatment
A Phase 2 study testing antihypertensive medications, Blood pressure measurement and Echocardiogram in people with Breast Cancer and Cardiotoxicity, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Cardiotoxicity
- What is being tested?
- antihypertensive medications, Blood pressure measurement and Echocardiogram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 7 sitesUnited States
- Study dates
- 18 Aug 2023to 30 May 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jennifer Liu, MD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Anthony Yu, MD, 212-639-7932
- Recruiting
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
Anthony Yu, MD, 212-639-7932
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Anthony Yu, MD, 212-639-7932
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Anthony Yu, MD, 212-639-7932
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Anthony Yu, MD, 212-639-7932
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Anthony Yu, MD, 212-639-7932
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Rockville Centre, New York, 11553
Anthony Yu, MD, 212-639-7932
About this study
Official title: Intensive Blood Pressure Control During Cardiotoxic Breast Cancer Treatment (PROTECT), A Randomized Controlled Trial
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
- Being tested
- antihypertensive medications, Blood pressure measurement, Echocardiogram, Symptom-limited cardiopulmonary exercise test, Quality of Life Measures
- Keywords
- Blood pressure, 23-159
- Medical subject headings
- Breast Neoplasms, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antihypertensive medicationsOther
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 measurementDiagnostic 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).
EchocardiogramDiagnostic test
At baseline, month 6, and month 12
Symptom-limited cardiopulmonary exercise testOther
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 MeasuresOther
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.
BiomarkersDiagnostic test
Research blood samples will be collected at baseline, 3 months, and 6 months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean change in systolic blood pressure (SBP) from baseline to 12 months
based upon in-office measurement
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start18 Aug 2023
- Primary completion1 Dec 2028 (estimated)
- Study completion30 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Yu, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023576
- Sponsor's protocol ID
- 23-159
- Status last verified
- May 2026
- First submitted
- 18 Aug 2023
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Blood Pressure Control During Cardiotoxic Breast Cancer Treatment (PROTECT), A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06023576
- Acronym / sponsor ID
- 23-159
- Conditions
- Breast Cancer, Cardiotoxicity
- Keywords
- Blood pressure, 23-159
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 30 May 2029 (estimated)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| standard-of-care antihypertensive medications | Experimental | Other: antihypertensive medications, Diagnostic Test: Blood pressure measurement, Diagnostic Test: Echocardiogram, Other: Symptom-limited cardiopulmonary exercise test, Other: Quality of Life Measures, Diagnostic Test: BiomarkersSBP 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. |
| higher dose antihypertensive medications | Experimental | Other: antihypertensive medications, Diagnostic Test: Blood pressure measurement, Diagnostic Test: Echocardiogram, Other: Symptom-limited cardiopulmonary exercise test, Other: Quality of Life Measures, Diagnostic Test: BiomarkersPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (26 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antihypertensive medicationsOne 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 | Other | higher dose antihypertensive medications, standard-of-care antihypertensive medications |
| Blood pressure measurementHome 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). | Diagnostic test | higher dose antihypertensive medications, standard-of-care antihypertensive medications |
| EchocardiogramAt baseline, month 6, and month 12 | Diagnostic test | higher dose antihypertensive medications, standard-of-care antihypertensive medications |
| Symptom-limited cardiopulmonary exercise testConsecutive 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. | Other | higher dose antihypertensive medications, standard-of-care antihypertensive medications |
| Quality of Life MeasuresFACT-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. | Other | higher dose antihypertensive medications, standard-of-care antihypertensive medications |
| BiomarkersResearch blood samples will be collected at baseline, 3 months, and 6 months | Diagnostic test | higher dose antihypertensive medications, standard-of-care antihypertensive medications |
Primary outcome
mean change in systolic blood pressure (SBP) from baseline to 12 months
Time frame: 12 months
based upon in-office measurement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Liu, MD contact
Anthony Yu, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing antihypertensive medications, Blood pressure measurement and Echocardiogram in people with Breast Cancer and Cardiotoxicity, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anthony Yu, MD (212-639-7932, yua3@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean change in systolic blood pressure (SBP) from baseline to 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.