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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
101
NTproBNP above the upper limit of normal will trigger the initiation of heart failure therapy with counseling from a study investigator based on protocol specified algorithm.
City of Hope
Duarte, California, United States
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, United States
Chester County Hospital
West Chester, Pennsylvania, United States
Recruitment Rate
percent of eligible patients who are randomized
Time frame: At baseline
Retention rate
percent of randomized patients who complete the study per protocol
Time frame: Through study completion (expected to be 1 year)
Adherence rate
percent of study activities completed in window
Time frame: Through study completion (expected to be 1 year)
Compliance rate
Compliance by PROMIS Scale v1.0 for patients in the biomarker guided arm initiated on heart failure medications
Time frame: Through study completion (expected to be 1 year)
Maximum tolerated dose
Maximum tolerated dosage of neurohormonal antagonist medications for patients in the biomarker-guided arm with NTproBNP above upper limit of normal
Time frame: Through study completion (expected to be 1 year)
Incidence of Adverse Events
Rate of Grade 2 or higher adverse events by CTCAEv5.0
Time frame: 12 months
Change in NTproBNP
Change in clinically measured NTproBNP following initiation of neurohormonal antagonists in patients with NTproBNP above upper limit of normal in the biomarker guided arm
Time frame: Through study completion (expected to be 1 year)
Change in Left ventricular ejection fraction (LVEF) by Echocardiogram
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Change in core-lab quantitated left ventricular ejection fraction
Time frame: 12 months
Incidence of cardiotoxicity
Incidence of cardiotoxicity defined as LVEF decline of at least 10% to less than 50%
Time frame: 12 months
Incidence of Hear Failure (HF)
Incidence of new or worsened clinical heart failure, defined as urgent or new office or emergency department visit or hospitalization for HF, adjudicated by a clinical events committee
Time frame: 12 months
Frequency of cancer treatment interruptions
Frequency of cancer treatment interruptions due to cardiotoxicity
Time frame: Through study completion (expected to be 1 year)