Blood Pressure Control During Breast Cancer Treatment
A Study of Blood Pressure Control During Cancer Treatment
Recruiting
Phase 2Interventional Study
Breast CancerCardiotoxicity
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
130 (estimated)
Sponsor
Memorial Sloan Kettering Cancer Center · Other
Who this trial is looking for
This trial is looking for women with breast cancer who need help controlling high blood pressure during their treatment. Participants will follow a specific plan for managing their blood pressure to see if it's more effective than standard methods.
I am receiving anthracycline-based chemotherapy and will have at least 2 cycles
My blood pressure is 130 mm Hg or higher
I am willing to use my mobile device for study requirements
I can complete a baseline exercise test safely
I can follow the study's instructions
You may not be able to join if
I have kidney problems with eGFR less than 30 ml/min
My arm is too large for blood pressure measurements
I cannot get an accurate blood pressure reading in one arm
I have had a heart attack in the past 3 months
I have severe heart failure within the last 6 months
I have a history of stroke
I have a heart transplant
I have a serious medical condition that affects my participation
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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Eligibility Criteria
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 com…
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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