Clinical trial · Observational
Cardiotoxicity in Breast Cancer Patients Treated With Proton or Photon Radiotherapy: A RadComp Companion Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cardiotoxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton vs Photon Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ancillary Cohort
- description
- 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.
- interventionNames
- Radiation: Proton vs Photon Radiation
Primary outcomes (5)
- measure
- Left ventricular ejection fraction (LVEF)
- timeFrame
- 14 months
- description
- Change in echocardiography derived LVEF from baseline
- measure
- Right Ventricular (RV) Fractional Area Change (FAC)
- timeFrame
- 14 months
- description
- Change in echocardiography derived RV FAC from baseline
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available