Clinical trial NCT04361240: Cardiotoxicity in Breast Cancer Patients Treated with Proton or Photon Radiotherapy: a RadComp Companion Study
Official title: Cardiotoxicity in Breast Cancer Patients Treated with Proton or Photon Radiotherapy: a RadComp Companion Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Cardiotoxicity
Keywords: Cardio-Oncology
Radiation Therapy Cardiotoxicity
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-04-24
Enrollment: 175
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients eligible for and enrolling on the RadComp trial at participating RadComp sites will be approached for the companion cohort.

Brief 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). 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Left ventricular ejection fraction (LVEF)
timeFrame: 14 months
measure: Right Ventricular (RV) Fractional Area Change (FAC)
timeFrame: 14 months
measure: Circulating N-terminal pro B-type natriuretic peptide (NTproBNP)
timeFrame: 14 months
measure: Circulating Placental Growth Factor (PIGF)
timeFrame: 14 months
measure: Circulating Growth Differentiation Factor-15 (GDF-15)
timeFrame: 14 months
Secondary outcomes:
measure: LV systolic strain
timeFrame: 14 months
measure: Echocardiography derived Ventricular Arterial Coupling Measurement
timeFrame: 14 months
measure: Diastolic function (E/e')
timeFrame: 14 months
measure: Circulating Troponin T(TnT)
timeFrame: 14 months
measure: Circulating high-sensitivity C-Reactive Protein (hsCRP)
timeFrame: 14 months
Other outcomes:
measure: 3D LVEF
timeFrame: 14 months
measure: 3D LV systolic strain
timeFrame: 14 months
measure: LV Twist and Torsion
timeFrame: 14 months
measure: Patient Reported Outcomes (PRO) Common Terms and Criteria for Adverse Events (CTCAE)
timeFrame: 14 months
measure: Incidence of major cardiovascular events (MCE)
timeFrame: 10 years
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Warrenville
country: United States
facility: Northwestern Medicine
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Philadelphia
country: United States
facility: Abramson Cancer Center at University of Pennsylvania
state: Pennsylvania
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Pennsylvania
name: Bonnie Ky, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: