Biomarker-Guided Intervention for Chemotherapy Toxicity in Cancer Patients

(NTproBNP-Guide Trial)

No longer recruiting at 2 trial locations

Overseen By Amanda Smith, MA

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Abramson Cancer Center of the University of Pennsylvania

Must not be taking: Antihypertensives, Angiotensin receptor blockers

Disqualifiers: Stage IV breast cancer, Uncontrolled hypertension, Severe hepatic impairment, End-stage renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a biomarker-guided approach can prevent heart problems in breast cancer and lymphoma patients receiving anthracycline chemotherapy. Researchers will monitor a specific biomarker, NTproBNP, to guide heart protection strategies (NTproBNP Guided Strategy of Cardioprotection) in one group, while the other group receives usual care without this monitoring. This trial is suitable for those diagnosed with breast cancer or lymphoma who are about to start anthracycline-based chemotherapy. The goal is to find safer chemotherapy strategies by reducing heart-related side effects. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works and measuring its effectiveness in an initial, smaller group of people, offering participants a chance to contribute to safer chemotherapy strategies.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using NTproBNP to protect the heart in cancer patients might be safe. NTproBNP is a blood marker that helps doctors assess heart health. This method is under investigation to determine if it can safeguard the heart during cancer treatment, particularly with anthracyclines, which can damage the heart.

Past studies have demonstrated that using NTproBNP to guide treatment helps identify patients at risk of heart problems. Patients monitored with NTproBNP had their heart health checked throughout their cancer treatment, allowing doctors to intervene early if heart issues began to appear.

While detailed safety figures from these studies are not available, the ongoing testing in humans suggests it is considered reasonably safe. Earlier studies showed that patients tolerated the monitoring without major problems. However, since this is an experimental method, participants should be aware of potential risks and discuss these with their healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the Biomarker-Guided Intervention for Chemotherapy Toxicity because it offers a personalized approach to protecting the heart during cancer treatment. Unlike standard care, which usually monitors heart health based on symptoms or routine checks, this method uses NTproBNP levels to actively guide cardioprotective strategies. This proactive monitoring could lead to more tailored interventions, potentially reducing heart damage caused by chemotherapy and improving overall patient outcomes.

What evidence suggests that this biomarker-guided strategy is effective for cardioprotection in cancer patients?

This trial will compare a biomarker-guided strategy using NT-proBNP with usual care. Studies have shown that NT-proBNP, a protein that helps predict heart stress and damage, may protect the heart during cancer treatment. Research indicates that patients with high NT-proBNP levels after chemotherapy face a higher risk of heart problems. By monitoring these levels, doctors can identify at-risk patients and potentially reduce heart damage. One study found that combining NT-proBNP monitoring with other heart tests improved the prediction of heart issues. These findings suggest that a heart protection strategy using NT-proBNP could effectively reduce heart-related side effects in cancer patients receiving anthracycline chemotherapy. ^{1 6 7 8 9}

Who Is on the Research Team?

Bonnie Ky, MD, MSCE

Principal Investigator

Perelman School of Medicine at the University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adults over 18 with breast cancer or lymphoma who are about to start anthracycline chemotherapy. They must be willing to follow the study plan and not have severe heart, liver, kidney issues, uncontrolled high blood pressure, or be in late-stage cancer. Pregnant or breastfeeding women can't join, and those able to have children must use birth control.

Inclusion Criteria

Provision of written informed consent and HIPAA authorization

I am willing and able to follow all study rules and attend all appointments.

I have breast cancer or lymphoma and will start anthracycline chemotherapy.

Exclusion Criteria

Non-English speaking

Your average systolic blood pressure is less than 90mmHg in the month before joining the study.

I am not pregnant or breastfeeding and will use effective birth control during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive anthracycline-based chemotherapy with biomarker-guided cardioprotection strategy

12 months

Visits at each chemotherapy cycle and at 3, 6, 9, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NTproBNP Guided Strategy of Cardioprotection

Trial Overview The study tests a new way of protecting the heart using NTproBNP biomarker levels to guide treatment during chemotherapy for breast cancer and lymphoma patients compared to standard care without this guidance.

How Is the Trial Designed?

Group I: Biomarker Guided Arm Experimental Treatment 1 Intervention

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.

Group II: Usual Care Active Control 1 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 Is Running the Clinical Trial?

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Kawut, Steven, MD

Collaborator

Trials

4

Recruited

130+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04737265

NCT04737265 | Pilot Study of an NTproBNP Guided ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9040117/

The Role of Cardioprotection in Cancer Therapy Cardiotoxicity Cardiotoxicity is a relatively frequent and potentially serious side effect of traditional and targeted cancer therapies.

3. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2022.898172/full

Early Predictive Value of NT-proBNP Combined With ... This study showed that the levels of NT-proBNP in the two groups were significantly higher after three cycles of chemotherapy and after ...

4. esmoopen.com esmoopen.com/article/S2059-7029(25)00985-8/fulltext

Cardioprotection in patients with anthracycline-treated ... Cardioprotective agents reduced subclinical damage in patients with breast cancer receiving anthracycline-based chemotherapy. Abstract.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11095874/

Improved Cardiomyopathy Risk Prediction Using Global ... In summary, we observed that the combination of abnormal baseline GLS and NT-proBNP was associated with a four-fold risk of postbaseline ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04737265/pilot-study-of-an-ntprobnp-guided-strategy-of-cardioprotection?q=congestive%20heart%20failure&page=4

Pilot Study of an NTproBNP Guided Strategy ... ... strategy using NT-proBNP to identify and treat patients with a high risk of cancer therapy-related cardiotoxicity. Patients will be enrolled ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666087322001120

The Role of Cardioprotection in Cancer Therapy ... Cardiotoxicity is a relatively frequent and potentially serious side effect of traditional and targeted cancer therapies. Both general measures and specific ...

8. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001032?utm_campaign=sciencenews22-23&utm_source=science-news&utm_medium=phd-link&utm_content=phd-09-21-23

Future Perspectives of Cardiovascular Biomarker ... ... risk stratification or monitoring of patients undergoing potentially cardiotoxic therapies (Table 1). ... Prevention of Chemotherapy Induced Cardiotoxicity ...

9. jtd.amegroups.org jtd.amegroups.org/article/view/23244/html

Biomarkers for the detection of apparent and subclinical ... Figure 1 Biomarkers in different forms of cancer therapy-related cardiotoxicity. Various forms of cancer therapy exhibit cardiotoxic side effects. Troponin may ...