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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04361240
• Other study ID #: UPCC 17119
• Status: Active, not recruiting
• Start date: August 1, 2020
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 175
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cardiotoxicity

Intervention

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

Locations

Country	Name	City	State
United States	Johns Hopkins	Baltimore	Maryland
United States	University of Alabama	Birmingham	Alabama
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Abramson Cancer Center at University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Washington	Seattle	Washington
United States	Northwestern Medicine	Warrenville	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	3D LVEF	Change in 3d echocardiography derived LVEF from baseline	14 months
Other	3D LV systolic strain	Change in 3D echocardiography derived longitudinal and circumferential strain from baseline	14 months
Other	LV Twist and Torsion	Change in 3D echocardiography derived measures of LV twist and torsion from baseline	14 months
Other	Patient Reported Outcomes (PRO) Common Terms and Criteria for Adverse Events (CTCAE)	Incidence and severity of PRO CTCAEs	14 months
Other	Incidence of major cardiovascular events (MCE)	Collected, defined, and adjudicated by the RadComp study team	10 years
Primary	Left ventricular ejection fraction (LVEF)	Change in echocardiography derived LVEF from baseline	14 months
Primary	Right Ventricular (RV) Fractional Area Change (FAC)	Change in echocardiography derived RV FAC from baseline	14 months
Primary	Circulating N-terminal pro B-type natriuretic peptide (NTproBNP)	Change in NTproBNP levels from baseline	14 months
Primary	Circulating Placental Growth Factor (PIGF)	Change in PIGF levels from baseline	14 months
Primary	Circulating Growth Differentiation Factor-15 (GDF-15)	Change in GDF-15 levels from baseline	14 months
Secondary	LV systolic strain	Change in 2D echocardiography derived LV global longitudinal strain and circumferential strain from baseline	14 months
Secondary	Echocardiography derived Ventricular Arterial Coupling Measurement	Change from baseline in ventricular arterial coupling as defined by end systolic elastance divided by effective arterial elastance	14 months
Secondary	Diastolic function (E/e')	Change in E/e' from baseline as measured by echocardiogram	14 months
Secondary	Circulating Troponin T(TnT)	Change in high-sensitivity TnT levels from baseline	14 months
Secondary	Circulating high-sensitivity C-Reactive Protein (hsCRP)	Change in hsCRP levels from baseline	14 months