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Biomarker-Guided Intervention for Chemotherapy Toxicity in Cancer Patients (NTproBNP-Guide Trial)

Phase 1 & 2

Waitlist Available

Led By Bonnie Ky, MD, MSCE

Research Sponsored by Abramson Cancer Center of the University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Uncontrolled blood pressure defined by SBP > 180mmHg on two or more occasions and taking three or more antihypertensives within 1 month prior to enrollment.

Patient must not have any of the following severe conditions: severe hepatic impairment, end-stage renal failure on dialysis, hyperkalemia with a potassium > 5.5 mEq/l, a history of kidney transplant, an eGFR < 30 ml/min/1.73m2, cardiogenic shock, decompensated heart failure requiring the use of IV inotropic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion (expected to be 1 year)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a biomarker-guided cardioprotection strategy using NTproBNP is safe and feasible for breast cancer and lymphoma patients treated with anthracyclines, as compared to usual care.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects aren't specified but may include reactions related to usual care cardioprotective measures taken as part of the biomarker-guided strategy versus standard treatments.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My blood pressure is very high despite taking three or more blood pressure medications.

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I do not have severe liver issues, end-stage kidney failure, very high potassium levels, a history of kidney transplant, extremely low kidney function, or severe heart failure.

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My breast cancer is at stage IV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion (expected to be 1 year)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion (expected to be 1 year)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (expected to be 1 year) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence rate

Compliance rate

Incidence of Adverse Events

+3 more

Secondary study objectives

Change in Left ventricular ejection fraction (LVEF) by Echocardiogram

Body Weight Changes

Frequency of cancer treatment interruptions

+2 more

Other study objectives

Change in Growth Differentiation Factor 15 (GDF-15)

Change in NTproBNP (post hoc batch analysis)

Change in circumferential strain

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Biomarker Guided ArmExperimental Treatment1 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 CareActive Control1 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.

0 / 3Eligibility criteria met