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

NCT ID: NCT04361240

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

172 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2025-05-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer Cardiotoxicity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Proton vs Photon Radiation

Intervention Type RADIATION

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

Interventions

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Proton vs Photon Radiation

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

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bonnie Ky, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Alabama

Birmingham, Alabama, United States

Site Status

Northwestern Medicine

Warrenville, Illinois, United States

Site Status

Johns Hopkins

Baltimore, Maryland, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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UPCC 17119

Identifier Type: -

Identifier Source: org_study_id

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