Intensive blood pressure management during breast cancer treatment

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

This study is testing if a more aggressive way to manage high blood pressure is safer and works better for people getting chemotherapy for breast cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Memorial Sloan Kettering Cancer Center (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 7 sites (Basking Ridge, New Jersey and 6 other locations)
• Trial ID: NCT06023576 on ClinicalTrials.gov

What this trial studies

This study investigates whether an intensive approach to managing high blood pressure is safer and more effective than standard treatment during breast cancer therapy. It focuses on patients undergoing anthracycline-based chemotherapy and aims to lower blood pressure levels while reducing the risk of cardiotoxicity. The trial will measure blood pressure, conduct echocardiograms, and assess quality of life, without testing specific medications. Participants will be monitored closely to evaluate the effectiveness of the treatment strategy.

Who should consider this trial

Good fit: Ideal candidates are females aged 18 and older with biopsy-proven breast cancer who are undergoing anthracycline-based chemotherapy and have high blood pressure.

Not a fit: Patients who do not have breast cancer or those with normal blood pressure levels may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the health outcomes of breast cancer patients by effectively managing blood pressure and reducing cardiotoxicity risks.

How similar studies have performed: Other studies have indicated that lowering blood pressure can improve patient health, but this specific approach in cancer patients is novel and has not been extensively tested.

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;
  * 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.

Where this trial is running

Basking Ridge, New Jersey and 6 other locations

• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
• Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
• Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack, New York, United States (Recruiting)
• Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (Recruiting)
• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
• Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Rockville Centre, New York, United States (Recruiting)

Study contacts

• Principal investigator: Anthony Yu, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Anthony Yu, MD

Conditions Breast Cancer; Cardiotoxicity; Blood pressure; 23-159