Cardiotoxicity in Breast Cancer Patients Treated With Proton or Photon Radiotherapy: A RadComp Companion Study

NCT04361240 | Completed

• 1 other identifier: UPCC 17119
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 6

Brief Summary

This is a companion study to the "Pragmatic Randomized Trial of Proton vs Photon Therapy for Patients with non-Metastatic Breast Cancer Receiving Comprehensive Nodal Radiation: A Radiotherapy Comparative Effectiveness (RadComp) Consortium Trial" (NCT02603341). The investigators will collect cardiovascular (CV) biomarkers and echocardiograms prior to, during, and for up to 1 year following radiation for a subset of patients enrolled on RadComp and to evaluate the impact of proton vs photon radiation therapy (RT) on CV function and structure.

Conditions

Cardiotoxicity; Breast Cancer

Keywords

Cardio-Oncology; Radiation Therapy Cardiotoxicity

Outcome Measures

Primary Outcomes (5)

• Left ventricular ejection fraction (LVEF)

  Change in echocardiography derived LVEF from baseline

  14 months

• Right Ventricular (RV) Fractional Area Change (FAC)

  Change in echocardiography derived RV FAC from baseline

  14 months

• Circulating N-terminal pro B-type natriuretic peptide (NTproBNP)

  Change in NTproBNP levels from baseline

  14 months

• Circulating Placental Growth Factor (PIGF)

  Change in PIGF levels from baseline

  14 months

• Circulating Growth Differentiation Factor-15 (GDF-15)

  Change in GDF-15 levels from baseline

  14 months

Secondary Outcomes (5)

• LV systolic strain

  14 months

• Echocardiography derived Ventricular Arterial Coupling Measurement

  14 months

• Diastolic function (E/e')

  14 months

• Circulating Troponin T(TnT)

  14 months

• Circulating high-sensitivity C-Reactive Protein (hsCRP)

  14 months

Other Outcomes (5)

• 3D LVEF

  14 months

• 3D LV systolic strain

  14 months

• LV Twist and Torsion

  14 months

Study Arms (1)

Ancillary Cohort

No Intervention: Subjects will be followed before, during and for up to 1 year after radiation with echocardiogram, blood draw, and symptoms and activity survey.

Radiation: Proton vs Photon Radiation

Interventions

Proton vs Photon Radiation RADIATION

Assignment to proton vs photon by randomization on RadComp parent study.

Ancillary Cohort

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients eligible for and enrolling on the RadComp trial at participating RadComp sites will be approached for the companion cohort.

You may qualify if:

• Consented to RadComp
• Willing and able to provide written consent

You may not qualify if:

• Knowledge of randomization on RadComp prior to enrollment on companion study
• Non-diagnostic echocardiography windows as assessed on local read.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (6)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

Northwestern Medicine

Warrenville, Illinois, 60555, United States

Location

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Serum, and Buffy coat are collected.

MeSH Terms

Conditions

Breast Neoplasms; Cardiotoxicity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Bonnie Ky, MD, MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 24, 2020
• Study Start: August 1, 2020
• Primary Completion: May 29, 2025
• Study Completion: May 29, 2025
• Last Updated: February 9, 2026

Record last verified: 2025-07

Locations

US (6)