Intensive Blood Pressure Control During Cardiotoxic Breast Cancer Treatment (PROTECT), A Randomized Controlled Trial

Memorial Sloan Kettering Cancer Center7 sites in 1 country130 target enrollmentAugust 18, 2023

ConditionsBreast Cancer Cardiotoxicity

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 130
Locations: 7
Primary Endpoint: mean change in systolic blood pressure (SBP) from baseline to 12 months
Status: Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 18, 2023

End Date

May 30, 2028

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

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 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;

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: