Breast CancerNCT04361240
Cardiotoxicity in Breast Cancer Patients Treated With Proton or Photon Radiotherapy: A RadComp Companion Study
An observational study of Breast Cancer and Cardiotoxicity, run by Abramson Cancer Center at Penn Medicine at 6 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Breast Cancer, Cardiotoxicity
- What is being tested?
- Proton vs Photon Radiation
- Type of treatment
- Surgery or procedure
- How many people
- 172 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Aug 2020to 29 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients eligible for and enrolling on the RadComp trial at participating RadComp sites will be approached for the companion cohort.
Who may be able to join
- Consented to RadComp
- Willing and able to provide written consent
Who cannot join
- Knowledge of randomization on RadComp prior to enrollment on companion study
- Non-diagnostic echocardiography windows as assessed on local read.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Johns Hopkins
Baltimore, Maryland, 21287
University of Alabama
Birmingham, Alabama, 35233
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Washington
Seattle, Washington, 98195
Northwestern Medicine
Warrenville, Illinois, 60555
About this 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.
Read the detailed description
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
- Breast Cancer, Cardiotoxicity
- Being tested
- Proton vs Photon Radiation
- Keywords
- Cardio-Oncology, Radiation Therapy Cardiotoxicity
- Medical subject headings
- Breast Neoplasms, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton vs Photon RadiationRadiation
Assignment to proton vs photon by randomization on RadComp parent study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Proton vs Photon Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction (LVEF)
Change in echocardiography derived LVEF from baseline
Measured: 14 months
Right Ventricular (RV) Fractional Area Change (FAC)
Change in echocardiography derived RV FAC from baseline
Measured: 14 months
Circulating N-terminal pro B-type natriuretic peptide (NTproBNP)
Change in NTproBNP levels from baseline
Measured: 14 months
Circulating Placental Growth Factor (PIGF)
Change in PIGF levels from baseline
Measured: 14 months
Circulating Growth Differentiation Factor-15 (GDF-15)
Change in GDF-15 levels from baseline
Measured: 14 months
Secondary outcomes (5)
LV systolic strain
Change in 2D echocardiography derived LV global longitudinal strain and circumferential strain from baseline
Measured: 14 months
Echocardiography derived Ventricular Arterial Coupling Measurement
Change from baseline in ventricular arterial coupling as defined by end systolic elastance divided by effective arterial elastance
Measured: 14 months
Diastolic function (E/e')
Change in E/e' from baseline as measured by echocardiogram
Measured: 14 months
Circulating Troponin T(TnT)
Change in high-sensitivity TnT levels from baseline
Measured: 14 months
Circulating high-sensitivity C-Reactive Protein (hsCRP)
Change in hsCRP levels from baseline
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Aug 2020
- Primary completion29 May 2025
- Study completion29 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Bonnie Ky, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361240
- Sponsor's protocol ID
- UPCC 17119
- Status last verified
- Jul 2025
- First submitted
- 6 Apr 2020
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiotoxicity in Breast Cancer Patients Treated With Proton or Photon Radiotherapy: A RadComp Companion Study
- ClinicalTrials.gov ID
- NCT04361240
- Acronym / sponsor ID
- UPCC 17119
- Conditions
- Breast Cancer, Cardiotoxicity
- Keywords
- Cardio-Oncology, Radiation Therapy Cardiotoxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary Cohort | – | Radiation: Proton vs Photon RadiationNo Intervention: Subjects will be followed before, during and for up to 1 year after radiation with echocardiogram, blood draw, and symptoms and activity survey. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients eligible for and enrolling on the RadComp trial at participating RadComp sites will be approached for the companion cohort.
Key inclusion criteria (2 listed)
- Consented to RadComp
- Willing and able to provide written consent
Key exclusion criteria (2 listed)
- Knowledge of randomization on RadComp prior to enrollment on companion study
- Non-diagnostic echocardiography windows as assessed on local read.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton vs Photon RadiationAssignment to proton vs photon by randomization on RadComp parent study. | Radiation | Ancillary Cohort |
Primary outcome
Left ventricular ejection fraction (LVEF)
Time frame: 14 months
Change in echocardiography derived LVEF from baseline
Right Ventricular (RV) Fractional Area Change (FAC)
Time frame: 14 months
Change in echocardiography derived RV FAC from baseline
Circulating N-terminal pro B-type natriuretic peptide (NTproBNP)
Time frame: 14 months
Change in NTproBNP levels from baseline
Circulating Placental Growth Factor (PIGF)
Time frame: 14 months
Change in PIGF levels from baseline
Circulating Growth Differentiation Factor-15 (GDF-15)
Time frame: 14 months
Change in GDF-15 levels from baseline
5 secondary outcomes
LV systolic strain
Time frame: 14 months
Echocardiography derived Ventricular Arterial Coupling Measurement
Time frame: 14 months
Diastolic function (E/e')
Time frame: 14 months
Circulating Troponin T(TnT)
Time frame: 14 months
Circulating high-sensitivity C-Reactive Protein (hsCRP)
Time frame: 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bonnie Ky, MD, MSCE principal investigator
University of Pennsylvania
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Cardiotoxicity, run by Abramson Cancer Center at Penn Medicine at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular ejection fraction (LVEF) (time frame: 14 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.