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

Sponsor
Abramson Cancer Center of the University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT04361240
Collaborator
(none)
155
Enrollment
4
Locations
36
Anticipated Duration (Months)
38.8
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an ancillary 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Radiation: Proton vs Photon Radiation

Detailed Description

The study population of the ancillary 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 ancillary study.

Study Design

Study Type:
Observational
Anticipated Enrollment :
155 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Cardiotoxicity in Breast Cancer Patients Treated With Proton or Photon Radiotherapy: A RadComp Ancillary Cohort Study
Actual Study Start Date :
Aug 1, 2020
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

ArmIntervention/Treatment
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.

Radiation: Proton vs Photon Radiation
Assignment to proton vs photon by randomization on RadComp parent study.

Outcome Measures

Primary Outcome Measures

  1. Left ventricular ejection fraction (LVEF) [14 months]

    Change in echocardiography derived LVEF from baseline

  2. Right Ventricular (RV) Fractional Area Change (FAC) [14 months]

    Change in echocardiography derived RV FAC from baseline

  3. Circulating N-terminal pro B-type natriuretic peptide (NTproBNP) [14 months]

    Change in NTproBNP levels from baseline

  4. Circulating Placental Growth Factor (PIGF) [14 months]

    Change in PIGF levels from baseline

  5. Circulating Growth Differentiation Factor-15 (GDF-15) [14 months]

    Change in GDF-15 levels from baseline

Secondary Outcome Measures

  1. LV systolic strain [14 months]

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

  2. Echocardiography derived Ventricular Arterial Coupling Measurement [14 months]

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

  3. Diastolic function (E/e') [14 months]

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

  4. Circulating Troponin T(TnT) [14 months]

    Change in high-sensitivity TnT levels from baseline

  5. Circulating high-sensitivity C-Reactive Protein (hsCRP) [14 months]

    Change in hsCRP levels from baseline

Other Outcome Measures

  1. 3D LVEF [14 months]

    Change in 3d echocardiography derived LVEF from baseline

  2. 3D LV systolic strain [14 months]

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

  3. LV Twist and Torsion [14 months]

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

  4. Patient Reported Outcomes (PRO) Common Terms and Criteria for Adverse Events (CTCAE) [14 months]

    Incidence and severity of PRO CTCAEs

  5. Incidence of major cardiovascular events (MCE) [10 years]

    Collected, defined, and adjudicated by the RadComp study team

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Consented to RadComp

  • Willing and able to provide written consent

Exclusion Criteria:
  • Knowledge of randomization on RadComp prior to enrollment on ancillary study

  • Non-diagnostic echocardiography windows as assessed on local read.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University of AlabamaBirminghamAlabamaUnited States35233
2Northwestern Medicine Proton CenterWarrenvilleIllinoisUnited States60555
3Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States10065
4Abramson Cancer Center at University of PennsylvaniaPhiladelphiaPennsylvaniaUnited States19104

Sponsors and Collaborators

  • Abramson Cancer Center of the University of Pennsylvania

Investigators

  • Principal Investigator: Bonnie Ky, MD, MSCE, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT04361240
Other Study ID Numbers:
  • UPCC 17119
First Posted:
Apr 24, 2020
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Abramson Cancer Center of the University of Pennsylvania
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021