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A Study of Blood Pressure Control During Breast Cancer Treatment for Prevention of Cardiotoxicity
Trial Status: active
This phase II trial compares the effect of an intensive approach of controlling blood pressure (BP) to a standard approach in preventing cardiotoxicity in patients undergoing breast cancer treatment. Having high BP and undergoing chemotherapy for the treatment of breast cancer can increase the risk of developing heart problems (cardiotoxicity). Cardiotoxicity is a condition when there is damage to the heart muscle. As a result of cardiotoxicity, the heart may not be able to pump blood throughout your body as well. High blood pressure may cause headaches, dizziness, blurred vision, and can damage to the heart. The goal of standard blood pressure treatment is for patients to have a systolic BP (SBP) of less than 140 mm Hg. SBP is a measurement of how well the heart pumps and is the top number of a blood pressure measurement. Researchers think a more intensive goal of a SBP of less than 120mm Hg may lower the risk of heart problems. Information gained from this trial may help researchers determine whether an intensive blood pressure treatment approach is safe and more effective than the standard approach at reducing BP and preventing cardiotoxicity in patients undergoing breast cancer treatment.
Inclusion Criteria
Age ≥ 18 years
Female assigned at birth
Biopsy proven breast cancer (stage I-IV)
Treatment with anthracycline-based chemotherapy (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 wireless fidelity (wifi) or cellular mobile device
For participants in the cardiopulmonary exercise test (CPET) cohort: Able to complete an acceptable baseline CPET, in the absence of high-risk electrocardiogram (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
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 (New York Heart Association [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
Additional locations may be listed on ClinicalTrials.gov for NCT06023576.
I. To evaluate the efficacy of an intensive SBP control intervention, compared to standard SBP control, during active breast cancer treatment in patients at risk for cardiotoxicity.
SECONDARY OBJECTIVES:
I. To compare mean change in SBP from baseline to 12 months between groups (based upon in-office measurement).
II. To compare SBP control as a binary outcome (< 120 mmHg) between groups at 6 and 12 months, based upon in-office measurement.
III. To compare mean change in SBP from baseline to 6 and 12 months between groups (based upon home blood pressure monitoring [HBPM]).
IV. To compare SBP control as a binary outcome (< 120mmHg) between groups at 6 and 12 months, based upon HBPM.
V. To assess the impact of intensive SBP control on imaging markers of cardiotoxicity as assessed by:
Va. Resting left ventricular ejection fraction (LVEF);
Vb. Myocardial strain (global longitudinal, circumferential, and radial strain);
Vc. Ventricular-arterial coupling.
VI. To assess the impact of intensive SBP control on cardiorespiratory fitness (CRF) assessed by peak oxygen consumption (VO2peak) in a subset of 33 participants per group.
VII. Cumulative incidence of cancer therapy-related cardiac dysfunction (defined by decrease in LVEF > 10% to < 53%, or decrease in global longitudinal strain [GLS] > 15%) and major adverse cardiovascular events (defined by myocardial infarction, stroke, or heart failure) at 12 months.
VIII. To evaluate the effect of intensive SBP control on circulating biomarkers of:
VIIIb. Cardiomyocyte death (cardiomyocyte cell-free deoxyribonucleic acid [DNA]);
VIIIc. Myocardial injury and stress (troponin, natriuretic peptide).
IX. To assess the impact of intensive SBP control on patient-reported outcomes.
X To characterize safety of intensive SBP control.
EXPLORATORY OBJECTIVES:
I. To explore the relationship between changes in SBP at 6 months and changes in cardiac imaging or functional measures at 6 months.
II. To explore the association between home blood pressure monitoring (HBPM) adherence at 6 months and changes in imaging/functional measures at 6 months.
III. To explore the correlation between changes in SBP at 6 months and changes in circulating biomarkers at 6 months.
IV. To explore the association between HBPM adherence at 6 months and changes in circulating biomarkers at 6 months.
V. To explore the relationship between HBPM adherence at 6 months and change in SBP at 6 months.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (STANDARD): Participants receive standard of care antihypertensive agents per physician discretion that are titrated over 12 months to reach and maintain a SBP goal of less than 140mm Hg on study. Patients also undergo echocardiography (ECHO) throughout the trial as well as blood sample collection during screening and on study.
ARM II (INTENSIVE): Participants receive standard of care antihypertensive agents per physician discretion that are titrated over 12 months to reach and maintain a SBP goal of less than 120mm Hg on study. Patients also undergo ECHO throughout the trial as well as blood sample collection during screening and on study.
After completion of study intervention, patients are followed up to 30 days.
Trial PhasePhase II
Trial Typeprevention
Lead OrganizationMemorial Sloan Kettering Cancer Center
