# Intensive Blood Pressure Control During Cardiotoxic Breast Cancer Treatment (PROTECT) Trial

> **NIH NIH R37** · SLOAN-KETTERING INST CAN RESEARCH · 2024 · $553,491

## Abstract

PROJECT SUMMARY
Hypertension (HTN) is the most common cardiovascular (CV) comorbidity among patients with breast cancer
and is an important modifiable risk factor for adverse CV events during and after cancer treatment. Work by our
group and others has shown that HTN is an important risk factor for cardiotoxicity caused by curative breast
cancer treatments including anthracyclines and human epidermal growth factor receptor 2 (HER2) targeted
agents, which occurs in up to 20% of patients receiving these therapies and presents with a reduced left
ventricular ejection fraction or heart failure. Furthermore, cardiotoxicity is a leading treatment-limiting toxicity that
interferes with curative cancer treatment delivery, worsens cancer outcomes, and leads to persistent impairment
of cardiorespiratory fitness in long-term survivors of breast cancer. CV disease is now a leading cause of
morbidity and mortality among breast cancer survivors who are living longer due to advances in cancer care,
therefore strategies to mitigate CV risk in patients with breast cancer are critically needed. No standard treatment
option is currently available to prevent cardiotoxicity during cancer treatment, and no guidelines exist to inform
the optimal approach to blood pressure control during cancer treatment. Multiple trials have shown that intensive
blood pressure control is associated with CV risk reductions, however exclusion of patients with cancer
represents an important limitation of these trials. The association between HTN and cardiotoxicity risk provide a
strong rationale for optimizing blood pressure control to improve CV health and reduce cardiotoxicity risk in
patients with HTN who are most vulnerable, however no previous trial has assessed the role of intensive blood
pressure control on the cardiotoxic effects of breast cancer treatment. The objective of this study is therefore to
evaluate intensive systolic blood pressure (SBP) control in women with HTN at risk for cardiotoxicity during BC
treatment and the effects of intensive SBP control on biomarkers (imaging, functional, and circulating) of
cardiotoxicity. Using a randomized controlled trial design, 130 patients with breast cancer at increased risk for
cardiotoxicity (defined by baseline SBP ≥130 mm Hg and treatment with anthracyclines with or without HER2-
targeted therapy) will be randomly allocated (ratio 1:1) to intensive SBP control (goal SBP <120 mm Hg) versus
standard SBP control (goal SBP <140 mm Hg) prior to initiating breast cancer treatment. Aim 1: Evaluate the
efficacy of an intensive SBP control intervention during active BC treatment in patients at risk for cardiotoxicity.
Aim 2: Evaluate the effects of intensive SBP control on imaging and functional biomarkers of cardiotoxicity. Aim
3: Assess the effect of intensive SBP control on circulating biomarkers of cardiotoxicity. The results from this
investigation will: 1) establish critical data to inform clinical implementation of intensive SBP c...

## Key facts

- **NIH application ID:** 10852910
- **Project number:** 5R37CA273923-02
- **Recipient organization:** SLOAN-KETTERING INST CAN RESEARCH
- **Principal Investigator:** Anthony Francis Yu
- **Activity code:** R37 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $553,491
- **Award type:** 5
- **Project period:** 2023-06-01 → 2028-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10852910

## Citation

> US National Institutes of Health, RePORTER application 10852910, Intensive Blood Pressure Control During Cardiotoxic Breast Cancer Treatment (PROTECT) Trial (5R37CA273923-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10852910. Licensed CC0.

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