Protocol Summary

Protocol No.: 13828

Sponsor Protocol No.: BR02

Study Title
Prospective Pilot Study of Early Markers of Radiation-Induced Cardiac Injury in Patients with Left-Sided Breast Cancer Receiving Photon or Proton Therapy

Principal Investigator(s)
Bradley, Julie

Objective
This is a pilot study to determine if there are changes in heart function following completion of radiation therapy for breast cancer as measured by cardiac magnetic resonance imaging (cardiac MRI) scans. Additional purposes of this study are to assess cardiac side effects from radiation treatment, evaluate cardiac MRI changes by radiation technique, and compare quality of life questionnaires.

Description
As part of this study, participants will have a cardiac MRI at baseline and a follow-up cardiac MRI within 1 year after completion of standard radiation therapy for left-sided breast cancer. The cardiac MRI scans will be evaluated to determine if there are changes in cardiac function within 1 year after radiation treatment.

Patients will be asked to complete a questionnaire before and after treatment that asks about their health and any symptoms they may be having.

Physical exams and any other standard of care service or treatment will be at the discretion of the treating physician.

Phase: Pilot

Age Group: Adult

Scope: Local

Treatment
Participants will have a cardiac MRI at baseline and within 1 year after completion of radiation therapy.

Detailed Eligibility
INCLUSION CRITERIA:
1. Ages 18 years old and older.
2. Left-sided breast cancer stage I-III.
3. Indications for adjuvant regional nodal and breast or chest wall radiation therapy (RT).
4. Women and men are allowed.
5. Must be at least 18 years old at time of consent.

EXCLUSION CRITERIA:
1. Pregnant and/or breastfeeding women or patients of child-producing potential not willing to use contraception while on study.
2. Prior history of cardiovascular disease per physician discretion.
3. Stage 0 and IV breast cancer.
4. Prior radiation therapy to chest.
5. Concurrent trastuzumab per physician discretion.
6. Contraindications to cardiac MRI (e.g., contrast reaction, metal implants, etc.).

Applicable Disease Sites
Breast Cancer

Participating Institutions
UF Gainesville : Ashley Williams
UF Jacksonville : Ashley Williams

Contact
Ashley Williams
Phone: 904-588-1451

Email: awilliams@floridaproton.org

More Information:
View study listing on ClinicialTrials.gov
http://www.clinicaltrials.gov/ct2/show/
NCT02199366