CompletedNot Applicable

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

United States172 participantsStarted 2020-08-01

Plain-language 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.

Who can participate

Age range21 Years

SexALL

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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.

What they're measuring

Left ventricular ejection fraction (LVEF)

Timeframe: 14 months

Right Ventricular (RV) Fractional Area Change (FAC)

Timeframe: 14 months

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

Timeframe: 14 months

Circulating Placental Growth Factor (PIGF)

Timeframe: 14 months

Circulating Growth Differentiation Factor-15 (GDF-15)

Timeframe: 14 months

Trial details

NCT IDNCT04361240

SponsorAbramson Cancer Center at Penn Medicine

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-05-29

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