CardiotoxicityPhase 1/2NTproBNP-GuideNCT04737265

Pilot Study of an NTproBNP Guided Strategy of Cardioprotection

A Phase 1/2 study testing Biomarker Guided Intervention in people with Cardiotoxicity and Toxicity Due to Chemotherapy, run by Abramson Cancer Center at Penn Medicine at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiotoxicity, Toxicity Due to Chemotherapy, Breast Cancer
What is being tested?: Biomarker Guided Intervention
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 108 participants
Where: 3 sitesUnited States
Study dates: 18 Mar 2021to 5 Feb 2025
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of written informed consent and HIPAA authorization
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, ≥ 18 years of age
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 neo-adjuvant or adjuvant systemic therapy.

Who cannot join

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 enrollment.
Baseline SBP < 90mmHg within 1 month prior to enrollment (if multiple blood pressures are available in the medical record within 1 month prior to enrollment, 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. All females of childbearing potential must have a blood test or urine study within 10 days prior to enrollment to rule out pregnancy. All females of childbearing potential must be strongly advised to use accepted and effective methods of contraception or to abstain from sexual intercourse for the duration of their participation in the study. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
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
Patient must not have any of the following

Show all 14Show fewer

Severe hepatic impairment, defined as serum bilirubin > Upper Limit of Normal (ULN), or AST or ALT > 5.0 ULN on most recent labs prior to enrollment. Results of serum bilirubin, AST, and ALT must be checked for screening if no results available in the medical recordwithin 28 days prior to enrollment.
end-stage renal failure on dialysis
hyperkalemia with a potassium > 5.5 mEq/l on most recent labs prior to enrollment. Serum potassium must be checked for screening if no results available in the EMR within 28 days prior to enrollment.
a history of kidney transplant
an eGFR < 30 ml/min/1.73m2 at most recent check prior to enrollment. Creatinine must be checked for screening if no results available in the EMR within 28 days prior to enrollment
cardiogenic shock
decompensated heart failure requiring the use of IV inotropic therapy
Non-English speaking

Trial locations and contacts

3 sites in 1 country.

United States3 sites

City of Hope
Duarte, California, 91010
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Chester County Hospital
West Chester, Pennsylvania, 19380

Other trials in United States

About this study

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

Read the detailed 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.

Conditions: Cardiotoxicity, Toxicity Due to Chemotherapy, Breast Cancer, Lymphoma, Cardiomyopathies, Heart Failure
Being tested: Biomarker Guided Intervention
Keywords: Risk-Guided Intervention, Cardiotoxicity of Chemotherapy, Cardio-Oncology, Cardiomyopathy
Medical subject headings: Cardiotoxicity, Breast Neoplasms, Lymphoma, Cardiomyopathies, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT04737265
Study group	Role	What they receive
Biomarker Guided Arm	Experimental	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. Receives: Other: Biomarker Guided Intervention
Usual Care	No 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Recruitment Rate
percent of patients approached about the study who provided consent
Measured: At baseline
Retention Rate
percent of randomized patients who complete the study per protocol
Measured: Through study completion (expected to be 1 year)
Compliance Rate
Compliance by Patient Reported Outcomes Information System (PROMIS) Scale v1.0 for patients in the biomarker guided arm initiated on heart failure medications. A higher PROMIS compliance score indicates better compliance with medications (score ranges from 9 - 45).
Measured: Through study completion (expected to be 1 year)
Maximum Dose
Maximum dose (mg) of neurohormonal antagonist therapy for participants in the intervention arm who initiated neurohormonal therapy for NTproBNP elevation across all study timepoints. Please note, due to numeric validation requirement, the max dose for combination drugs reported below is the max dose for the component in our algorithm (e.g. valsartan-hydrochlorothiazide is reported below as 325, which is the max dose of valsartan).
Measured: Through study completion (expected to be 1 year)
Incidence of Adverse Events
Number of patients that had at least one targeted AE of grade 3 or higher at any time on study.
Measured: 12 months

Secondary outcomes (5)

Change in NTproBNP
Change in estimated core lab measured NTproBNP by group. GEE model adjusted for baseline values and time since anthracycline initiation, modeled with spline function. NTproBNP is a hormone released when the heart is under stress. Concentrations greater than 125 pg/ml are considered to be elevated.
Measured: Through study completion (1 year)
Change in Left Ventricular Ejection Fraction (LVEF)
Change in core-lab quantitated LVEF by echocardiogram from baseline. GEE model adjusted for baseline values and time since anthracycline initiation, modeled with spline function. LVEF is a measurement of how much blood the heart pumps out with each beat. It is calculated by dividing the volume of blood ejected with each beat divided the volume of blood in the heart, multiplied by 100 and reported as a percentage. An LVEF of less than 50% is considered abnormal.
Measured: 12 months
Incidence of Cardiotoxicity
Incidence of cardiotoxicity defined as LVEF decline of at least 10% to less than 50%
Measured: 12 months
Incidence of Heart Failure (HF)
Incidence of new or worsened clinical heart failure, defined as urgent or new office or emergency department visit or hospitalization for adjudicated heart failure.
Measured: 12 months
Frequency of Cancer Treatment Interruptions
Frequency of cancer treatment interruptions (holds or early discontinuations)
Measured: Through study completion (expected to be 1 year)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Mar 20215 Feb 2025

First posted3 Feb 2021
Study start18 Mar 2021
Primary completion5 Feb 2025
Study completion5 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for CardiotoxicityStudies of the same condition, open and under way.
More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Serial monitoring of NTproBNP during chemotherapy will be used to identify high-risk patients in the intervention arm; patients who experience elevations in NTproBNP will be initiated and titrated on a personalized regimen of neurohormonal antagonists. Patients in the usual care arm will not have serial NTproBNP monitoring and will be managed according to usual care.
Masking: None (open label)
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04737265
Sponsor's protocol ID: UPCC 25920
Other IDs: R21HL152148
Acronym: NTproBNP-Guide
Status last verified: Jun 2026
First submitted: 28 Jan 2021
Last updated: 15 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Xia C, Smith AM, Lefebvre B, Jamal FA, Armenian SH, Koropeckyj-Cox D, Zhang L, Liu PP, Landsburg D, Clark AS, Shah PD, Hubbard RA, Huang A, Golec S, Hewitt M, Wilcox NS, Chen Z, Rethy L, Jung W, Ko K, Narayan V, Martei YM, Lang NN, Januzzi JL, Felker GM, Ky B. Biomarker-Guided Cardioprotection for Patients Treated With Anthracyclines: A Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2546201. doi: 10.1001/jamanetworkopen.2025.46201.
PubMed 41335439

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open Label Pilot Trial of a Biomarker Guided Strategy of Cardioprotection in Patients With Lymphoma or Breast Cancer Treated With Anthracyclines
ClinicalTrials.gov ID: NCT04737265
Acronym / sponsor ID: NTproBNP-Guide / UPCC 25920
Conditions: Cardiotoxicity, Toxicity Due to Chemotherapy, Breast Cancer, Lymphoma, Cardiomyopathies, Heart Failure
Keywords: Risk-Guided Intervention, Cardiotoxicity of Chemotherapy, Cardio-Oncology, Cardiomyopathy
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: Abramson Cancer Center at Penn MedicineUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 18 Mar 2021 (actual)
Primary completion: 5 Feb 2025 (actual)
Study completion: 5 Feb 2025 (actual)
First posted: 3 Feb 2021 (actual)
Results: Posted 15 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Serial monitoring of NTproBNP during chemotherapy will be used to identify high-risk patients in the intervention arm; patients who experience elevations in NTproBNP will be initiated and titrated on a personalized regimen of neurohormonal antagonists. Patients in the usual care arm will not have serial NTproBNP monitoring and will be managed according to usual care.

Arm	Type	Receives
Biomarker Guided Arm	Experimental	Other: Biomarker Guided InterventionNTproBNP 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.
Usual Care	No 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Provision of written informed consent and HIPAA authorization
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, ≥ 18 years of age
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 neo-adjuvant or adjuvant systemic therapy.

Key exclusion criteria (14 listed)

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 enrollment.
Baseline SBP < 90mmHg within 1 month prior to enrollment (if multiple blood pressures are available in the medical record within 1 month prior to enrollment, 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. All females of childbearing potential must have a blood test or urine study within 10 days prior to enrollment to rule out pregnancy. All females of childbearing potential must be strongly advised to use accepted and effective methods of contraception or to abstain from sexual intercourse for the duration of their participation in the study. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Biomarker Guided InterventionNTproBNP 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.	Other	Biomarker Guided Arm

Primary outcome

Recruitment Rate
Time frame: At baseline
percent of patients approached about the study who provided consent
Retention Rate
Time frame: Through study completion (expected to be 1 year)
percent of randomized patients who complete the study per protocol
Compliance Rate
Time frame: Through study completion (expected to be 1 year)
Compliance by Patient Reported Outcomes Information System (PROMIS) Scale v1.0 for patients in the biomarker guided arm initiated on heart failure medications. A higher PROMIS compliance score indicates better compliance with medications (score ranges from 9 - 45).
Maximum Dose
Time frame: Through study completion (expected to be 1 year)
Maximum dose (mg) of neurohormonal antagonist therapy for participants in the intervention arm who initiated neurohormonal therapy for NTproBNP elevation across all study timepoints. Please note, due to numeric validation requirement, the max dose for combination drugs reported below is the max dose for the component in our algorithm (e.g. valsartan-hydrochlorothiazide is reported below as 325, which is the max dose of valsartan).
Incidence of Adverse Events
Time frame: 12 months
Number of patients that had at least one targeted AE of grade 3 or higher at any time on study.

5 secondary outcomes

Change in NTproBNP
Time frame: Through study completion (1 year)
Change in Left Ventricular Ejection Fraction (LVEF)
Time frame: 12 months
Incidence of Cardiotoxicity
Time frame: 12 months
Incidence of Heart Failure (HF)
Time frame: 12 months
Frequency of Cancer Treatment Interruptions
Time frame: Through study completion (expected to be 1 year)

Results and safety

Results posted to the registry on 15 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Biomarker Guided Arm	51	47
Usual Care	50	42

Primary outcome: Recruitment Rate

Time frame: At baseline. Count of participants. Unit: Participants

Measure	Number of Consented Patients n = 220
Value	108

Population analysed: We defined recruitment rate as the percent of patients approached about the study who consented to participate

Primary outcome: Retention Rate

Time frame: Through study completion (expected to be 1 year). Count of participants. Unit: Participants

Measure	Biomarker Guided Arm n = 50	Usual Care n = 46
Value	47	42

Population analysed: The analysis population for retention rate excludes those patients who died while on study.

Primary outcome: Compliance Rate

Time frame: Through study completion (expected to be 1 year). Median (Inter-Quartile Range). Unit: score on a scale

Measure	Intervention Arm Patients Treated With Neurohormal Therapy n = 23
Value	31 (17 to 33)

Population analysed: In total, 27 patients on the intervention arm experienced at least 1 NTproBNP elevation. Of these, 4 did not have any initiation or titration of neurohormonal medications at any point. The analysis population for compliance with study medications includes only those patients who initiated or titrated neurohormonal medications for NTproBNP elevation.

Primary outcome: Maximum Dose

Time frame: Through study completion (expected to be 1 year). Median (Inter-Quartile Range). Unit: mg

Measure	Intervention Arm Patients on Carvedilol n = 9	Intervention Arm Patients on Metoprolol n = 5	Intervention Arm Patients on Lisinopril n = 19	Intervention Arm Patients on Losartan n = 4	Intervention Arm Patients on Irbesartan n = 1	Intervention Arm Patients on Valsartan n = 5	Intervention Arm Patients on Spironolactone n = 2	Intervention Arm Patients on Eplerenone n = 5	Intervention Arm Patients on Valsartan-Hydrochlorothiazide n = 1	Intervention Arm Patients on Sacubitril-valsartan n = 2
Value	12.5 (6.25 to 25)	100 (50 to 125)	6.25 (2.5 to 25)	50 (25 to 100)	75 (75 to 75)	40 (40 to 73)	25 (25 to 50)	25 (25 to 50)	320 (320 to 320)	52 (52 to 52)

Population analysed: For this outcome measure, we consider only those patients randomized to the intervention arm who initiated and/or titrated at least one neurohormonal therapy for NTproBNP elevation on trial.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment through end of follow-up (up to 12 months). Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Biomarker Guided Arm	9 of 50 (18%)	47 of 50 (94%)	0 of 50
Usual Care	14 of 50 (28%)	46 of 50 (92%)	4 of 50

Limitations and caveats (from the sponsor): Limitations of this study include the relatively small sample size; heterogeneity in study population; the inclusion of patients treated with neurohormonal therapy prior to enrollment which was done to allow a more representative sample; the open-label design (although all outcomes were centrally adjudicated); and a follow-up period of 12 months.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41335439Xia C, Smith AM, Lefebvre B, Jamal FA, Armenian SH, Koropeckyj-Cox D, Zhang L, Liu PP, Landsburg D, Clark AS, Shah PD, Hubbard RA, Huang A, Golec S, Hewitt M, Wilcox NS, Chen Z, Rethy L, Jung W, Ko K, Narayan V, Martei YM, Lang NN, Januzzi JL, Felker GM, Ky B. Biomarker-Guided Cardioprotection for Patients Treated With Anthracyclines: A Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2546201. doi: 10.1001/jamanetworkopen.2025.46201.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bonnie Ky, MD, MSCE principal investigator

Perelman School of Medicine at the University of Pennsylvania

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Biomarker Guided Intervention in people with Cardiotoxicity and Toxicity Due to Chemotherapy, run by Abramson Cancer Center at Penn Medicine at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Rate (time frame: At baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04737265, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.