Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Heart and Blood Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Breast Neoplasms

Cardiotoxicity

Breast Diseases

Skin Diseases

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

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.

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

Proton vs Photon Radiation

Bonnie Ky, MD, MSCE

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.

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.

Plasma, Serum, and Buffy coat are collected.

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

Participants may opt in to allowing data and/or banked samples to be used for future research and shared with other researchers. A detailed plan for sharing IPD will be finalized at a later date, and may depend in part on how many participants elect this option. Additional supporting information may be shared, including the study protocol and informed consent form.

Change in 3d echocardiography derived LVEF from baseline

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

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

Collected, defined, and adjudicated by the RadComp study team

Change in echocardiography derived LVEF from baseline

Change in echocardiography derived RV FAC from baseline

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

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

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

Change in high-sensitivity TnT levels from baseline

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cardiotoxicity in Breast Cancer Patients Treated With Proton or Photon Radiotherapy: A RadComp Companion Study	NCT04361240	Breast Cancer Cardiotoxicity	Proton vs Photo...	21 Years -	Abramson Cancer Center at Penn Medicine
Cardiotoxicity in Breast Cancer Patients Treated With Proton or Photon Radiotherapy: A RadComp Companion Study	NCT04361240	Breast Cancer Cardiotoxicity	Proton vs Photo...	21 Years -	Abramson Cancer Center at Penn Medicine
Cardiotoxicity in Breast Cancer Patients Treated With Proton or Photon Radiotherapy: A RadComp Companion Study	NCT04361240	Breast Cancer Cardiotoxicity	Proton vs Photo...	21 Years -	Abramson Cancer Center at Penn Medicine

Spots Global Cancer Trial Database for proton vs photon radiation