An interventional study of Photon and Proton in Breast Cancer, sponsored by Abramson Cancer Center at Penn Medicine. Active, not recruiting at 40 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-11-06.
Sponsored by Abramson Cancer Center at Penn Medicine · Not applicable, Interventional, and Treatment
A pragmatic randomized clinical trial of patients with locally advanced breast cancer randomized to either proton or photon therapy and followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life, and cancer control outcomes. Quality of life is the outcome measure for the estimated primary completion date of December, 2024, www.radcomp.org.
Because no one knows which radiation treatment is best, if you decide to take part in this study, you will be randomly assigned to 1 of 2 treatment groups, and then you will begin radiation treatment according to usual medical practice. Randomly assigning you to a group helps makes sure that each group has a similar mix of patients and makes the study better - and is only done when doctors are not sure whether one treatment is better than the other. You have an equal chance of getting into either treatment group, like a coin flip. Both you and your doctor will be told which treatment you will get.
No matter which group patients are in, doctors will work very carefully to reduce the radiation to healthy tissues. Both groups will followed for at least 10 years after completing radiation therapy. The results of this study will help decide which radiation is best for future patients with your type of breast cancer.
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 1,238 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Photon therapy: once a day, 5 days a week, for 5 to 7 weeks
Radiation: Photon
Proton therapy: once a day, 5 days a week, for 5 to 7 weeks
Radiation: Proton
Photon Therapy:once a day, 5 days a week, for 5 to 7 weeks
Proton Therapy: once a day, 5 days a week, for 5 to 7 weeks
Effectiveness of proton therapy vs. photon therapy
Compare the effectiveness of proton vs. photon therapy in reducing major cardiovascular events (MCE), defined as atherosclerotic coronary heart disease or other heart disease death, myocardial infarction, coronary revascularization, or hospitalization for major cardiovascular event (heart failure, valvular disease, arrhythmia, or unstable angina).
Time frame: 10 years
Disease Control
Compare the non-inferiority of proton vs. photon therapy in reducing ipsilateral breast cancer local-regional recurrence and in reducing any recurrence, defined as the first reported breast cancer recurrence of any type (local-regional or distant or cancer-specific mortality)
Time frame: 5 years
Patient-reported Body Image and Function, Fatigue and Other Measures of Health-related Quality of Life (HRQOL)
Compare the effectiveness of proton vs. photon therapy in improving patient-reported body image and function, fatigue and other measures of health-related quality of life (HRQOL) (anxiety, social roles, financial toxicity, general satisfaction) and adverse events.
Time frame: 5 years
Radiation Dose and Quality of Life and Cardiac Toxicity
Develop predictive models to examine the association of radiation dose distribution (to heart and other normal tissues) and major cardiovascular events and quality of life outcomes.
Time frame: 5 years
Long Term Survival
To assess longer-term rates of breast cancer specific and overall survival and development of second malignancies.
Time frame: 15 years
This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Abramson Cancer Center at Penn Medicine