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NCT Number: NCT04361240

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

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.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama, Birmingham, Alabama, United States

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About this study

The study population of the companion study will consist of newly enrolled RadComp trial participants. Patients on this ancillary will be consented prior to RadComp randomization to decrease the bias secondary to RT type and enhance internal validity. The study will define the early changes in biomarkers, imaging measures, and RT dose volume metrics and long-term (5-10 year) CV clinical outcomes using the RadComp parent study's infrastructure for clinical data collection and long-term follow-up. Blood samples, echocardiograms, and questionnaires are obtained at baseline (between end of chemotherapy and start of RT), immediately after the end of RT, and at 6 months and 12 months after the end of RT. An additional blood sample will be collected at 4 weeks after the start of RT. Clinical, demographic, and patient reported outcomes data are collected as part of the RadComp parent study. In addition to data collected by RadComp, we will collect a limited set of clinical data and two additional quality of life instruments for the companion study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Proton vs Photon Radiation

Radiation

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

Primary outcomes

  1. Left ventricular ejection fraction (LVEF)

    Time frame: 14 months

    Change in echocardiography derived LVEF from baseline

  2. Right Ventricular (RV) Fractional Area Change (FAC)

    Time frame: 14 months

    Change in echocardiography derived RV FAC from baseline

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

    Time frame: 14 months

    Change in NTproBNP levels from baseline

  4. Circulating Placental Growth Factor (PIGF)

    Time frame: 14 months

    Change in PIGF levels from baseline

  5. Circulating Growth Differentiation Factor-15 (GDF-15)

    Time frame: 14 months

    Change in GDF-15 levels from baseline

Secondary outcomes

  1. LV systolic strain

    Time frame: 14 months

    Change in 2D echocardiography derived LV global longitudinal strain and circumferential strain from baseline

  2. Echocardiography derived Ventricular Arterial Coupling Measurement

    Time frame: 14 months

    Change from baseline in ventricular arterial coupling as defined by end systolic elastance divided by effective arterial elastance

  3. Diastolic function (E/e')

    Time frame: 14 months

    Change in E/e' from baseline as measured by echocardiogram

  4. Circulating Troponin T(TnT)

    Time frame: 14 months

    Change in high-sensitivity TnT levels from baseline

  5. Circulating high-sensitivity C-Reactive Protein (hsCRP)

    Time frame: 14 months

    Change in hsCRP levels from baseline

Other outcomes

  1. 3D LVEF

    Time frame: 14 months

    Change in 3d echocardiography derived LVEF from baseline

  2. 3D LV systolic strain

    Time frame: 14 months

    Change in 3D echocardiography derived longitudinal and circumferential strain from baseline

  3. LV Twist and Torsion

    Time frame: 14 months

    Change in 3D echocardiography derived measures of LV twist and torsion from baseline

  4. Patient Reported Outcomes (PRO) Common Terms and Criteria for Adverse Events (CTCAE)

    Time frame: 14 months

    Incidence and severity of PRO CTCAEs

  5. Incidence of major cardiovascular events (MCE)

    Time frame: 10 years

    Collected, defined, and adjudicated by the RadComp study team

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2020
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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