Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT06023576

A Study of Blood Pressure Control During Cancer Treatment

Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-14

130

Participants Needed

7

Research Sites

301 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

A Study of Blood Pressure Control During Cancer Treatment

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Female assigned at birth
  • Biopsy-proven breast cancer (stage I-IV)
  • Planned treatment with at least 2 cycles of anthracycline-based chemotherapy (with or without HER2-targeted therapy)
  • Systolic blood pressure of 130 mm Hg or higher
  • Willing and able to follow the study requirements
  • Must have and be willing to use a Bluetooth-enabled WiFi or cellular mobile device
  • For CPET subgroup: able to complete acceptable baseline cardiopulmonary exercise test without high-risk findings or inappropriate exercise response
Not Eligible

You will not qualify if you...

  • Estimated glomerular filtration rate (eGFR) below 30 ml/min/1.73m2
  • Arm circumference too large for accurate blood pressure measurement with available devices
  • Unable to accurately measure blood pressure in at least one arm (e.g., bilateral upper extremity lymphedema)
  • Cardiac conditions including acute coronary syndrome within 3 months, symptomatic heart failure (NYHA class III/IV) within past 6 months, history of stroke, or cardiac transplantation
  • Any other medical condition that would impair ability to participate or adhere to study interventions
  • For CPET subgroup: absolute contraindications to exercise testing such as recent myocardial infarction, unstable angina, uncontrolled arrhythmias, severe aortic stenosis, recurrent syncope, active infections or serious pulmonary or cardiac conditions, mental impairment preventing cooperation

AI-Screening

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Trial Site Locations

Total: 7 locations

1

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

2

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States, 07748

Actively Recruiting

3

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States, 07645

Actively Recruiting

4

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States, 11725

Actively Recruiting

5

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States, 10604

Actively Recruiting

6

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

Actively Recruiting

7

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Rockville Centre, New York, United States, 11553

Actively Recruiting

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Research Team

A

Anthony Yu, MD

CONTACT

J

Jennifer Liu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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