A Randomized, Open Label Pilot Trial of a Biomarker Guided Strategy of Cardioprotection in Patients With Lymphoma or Breast Cancer Treated With Anthracyclines
Who is this study for? Patients with Cardiotoxicity, Breast Cancer, Lymphoma, Cardiomyopathies, Heart Failure
What treatments are being studied? Biomarker Guided Intervention
Status: Completed
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
City of Hope
Duarte
Pennsylvania
Abramson Cancer Center at University of Pennsylvania
Philadelphia
Chester County Hospital
West Chester
Time Frame
Start Date: 2021-03-18
Completion Date: 2025-02-05
Participants
Target number of participants: 101
Treatments
Experimental: Biomarker Guided Arm
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.
No_intervention: Usual Care
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.
Related Therapeutic Areas
Sponsors
Leads: Abramson Cancer Center at Penn Medicine
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)