Pilot Study of an NTproBNP Guided Strategy of Cardioprotection

  • STATUS
    Recruiting
  • End date
    Mar 1, 2025
  • participants needed
    100
  • sponsor
    Abramson Cancer Center of the University of Pennsylvania
Updated on 1 November 2021
cancer
lymphoma
heart failure
anthracyclines
chemotherapy regimen
n-terminal pro-bnp

Summary

Investigators will evaluate the safety and feasibility of a biomarker-guided cardioprotection strategy using NTproBNP, as compared to usual care, in breast cancer and lymphoma patients treated with anthracyclines.

Description

This is a randomized, open-label pilot trial of a biomarker-guided strategy using NT-proBNP to identify and treat patients with a high risk of cancer therapy-related cardiotoxicity. Patients will be enrolled and randomized prior to initiation of anthracycline-based therapy and followed for 12 months with blood samples, echocardiography, and patient reported outcomes surveys. The overall hypothesis is that a biomarker guided treatment strategy that initiates neurohormonal antagonists in breast cancer or lymphoma patients who have increases in NT-proBNP prior to, during, or after anthracyclines will be feasible, well-tolerated, and result in attenuation of cardiotoxicity, compared to standard care.

Details
Condition Lymphoma, Heart failure, Heart disease, Breast Cancer, Lymphoproliferative Disorder, Lymphoma, Cardiomyopathy, Non-Hodgkin's Lymphoma, Cardiotoxicity, Breast Cancer Diagnosis, Cardiac Toxicity, Toxicity Due to Chemotherapy, Congestive Heart Failure, Lymphoproliferative disorders, Cardiac Disease, breast carcinoma, cancer, breast, cardiomyopathies, myocardial diseases, lymphomas, cardiac failure, congestive heart disease
Treatment Biomarker Guided Intervention
Clinical Study IdentifierNCT04737265
SponsorAbramson Cancer Center of the University of Pennsylvania
Last Modified on1 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosed with breast cancer or lymphoma (any subtype), planned to receive an anthracycline based chemotherapy regimen. Patients may be enrolled up to their first dose of anthracycline even if they have already received other chemotherapeutic or targeted agents as part of neoadjuvant or adjuvant systemic therapy

Exclusion Criteria

Diagnosed with Stage IV breast cancer
Uncontrolled blood pressure defined by systolic blood pressure (SBP) > 180mmHg on two or more occasions and taking three or more antihypertensives within 1 month prior to start of anthracyclines
Baseline SBP < 90mmHg (if multiple blood pressures are available in the medical record within 1 month prior to screening, the average SBP will be considered)
Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with some anti-hypertensives, including angiotensin receptor blockers
Patient with prior or concurrent malignancy whose natural history of treatment, in the opinion of the investigator, has the potential to interfere with the safety or efficacy assessment of the investigational regimen
Severe hepatic impairment, defined as serum bilirubin > upper limit of normal, or AST or ALT > 5.0 upper limit of normal within 28 days of enrollment
Patient must not have end-stage renal failure on dialysis, history of repeated hyperkalemia with a potassium > 5.5 mEq/l, or have a history of kidney transplant, or an eGFR < 30 ml/min/1.73m2
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