CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 108 enrolled / 108 target
Drug / intervention
Biomarker Guided Interventionother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04737265
NCT04737265Phase 1CompletedOn Track (1.7/mo)Completion was 16mo ago
CompareCT.gov

A Randomized, Open Label Pilot Trial of a Biomarker Guided Strategy of Cardioprotection in Patients With Lymphoma or Breast Cancer Treated With Anthracyclines

Abramson Cancer Center at Penn Medicine·interventional·Posted Feb 3, 2021·Updated Jun 15, 2026

In Brief

A Phase 1 clinical trial evaluating Biomarker Guided Intervention for Cardiotoxicity and 5 related conditions. Completed, enrolled 108 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiotoxicity, Toxicity Due to Chemotherapy, Breast Cancer, Lymphoma, Cardiomyopathies, Heart Failure
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedFeb 3, 2021
Enrollment StartMar 18, 2021
Primary CompletionFeb 5, 2025
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 5.4 years ago

Arms & Interventions

Biomarker Guided Armexperimental

NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy.

Other: Biomarker Guided Intervention
Usual Careno_intervention

NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. Biomarker data will also be collected at each cycle of Anthracycline chemotherapy.

Interventions

Biomarker Guided Interventionother

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.