Biomarker-Guided Intervention for Chemotherapy Toxicity in Cancer Patients

(NTproBNP-Guide Trial)

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

101 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Bonnie Ky, MD, MSCE

Principal Investigator

Perelman School of Medicine at the University of Pennsylvania

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+