Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial

Running, not enrolling · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02603341

Run by

Abramson Cancer Center at Penn Medicine

People needed

1238

Starts

2016-04-06

Expected to finish

2036-11-01

Last updated by the study team

2025-11-06

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Females or males diagnosed with pathologically (histologically) proven invasive mammary carcinoma (ductal, lobular or other) of the breast who have undergone either mastectomy or lumpectomy with any type of axillary surgery or axillary sampling.
• For patients who have undergone lumpectomy, any type of mastectomy and any type of reconstruction (including no reconstruction) are allowed.
• For patients who have undergone lumpectomy, there are no breast size limitations.
• Patients with non-metastatic breast cancer are eligible. This includes American Joint Committee on Cancer (AJCC) 7th edition left- or right-sided breast cancer clinical or pathologic stage I, II, III or loco-regionally recurrent at time of diagnosis. For patients that receive neoadjuvant chemotherapy, AJCC 7th edition left- or right-sided breast cancer pathologic stage yp 0, I, II, III are eligible.
• Bilateral breast cancer is permitted. Patients with bilateral breast cancer will be stratified as left-sided.
• Must be proceeding with breast/chest wall and nodal radiation therapy including internal mammary node treatment.
• Must have a pertinent history/physical examination within 90 days prior to registration.
• Age ≥ 21 years
• ECOG Performance Status 0 - 2 (asymptomatic to symptomatic but capable of self-care) within 90 days prior to randomization.
• Confirmation that the patient's health insurance will pay for the treatment in this study (patients may still be responsible for some costs, such as co-pays and deductibles). If the patient's insurance will not cover a specific treatment in this study and the patient still wants to participate, confirmation that the patient would be responsible for paying for any treatment received.
• Patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 180 days prior to registration as documented in the medical record. HIV testing is not required for eligibility for this protocol.
• The patient must provide study-specific informed consent prior to study entry.

You may not qualify if…

• Definitive clinical or radiologic evidence of metastatic disease, as documented by the treating institution.
• Prior radiotherapy to the ipsilateral chest wall or ipsilateral breast or thorax. Individuals with prior radiotherapy in the contralateral breast or chest wall are eligible.
• Any radiation therapy for the currently diagnosed breast cancer prior to randomization.
• Dermatomyositis with a CPK level above normal or with an active skin rash or scleroderma.
• Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Mayo Clinic-Arizona — Phoenix, Arizona, United States
• UC San Diego — San Diego, California, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• University of Miami Sylvester Cancer Center at Coral Gables — Coral Gables, Florida, United States
• University of Miami Sylvester Cancer Center - Deerfield — Deerfield Beach, Florida, United States
• University of Florida Health — Gainesville, Florida, United States
• University of Florida Health Proton Therapy Institute — Jacksonville, Florida, United States
• University of Miami Sylvester Cancer Center — Miami, Florida, United States
• Miami Cancer Insititute — Miami, Florida, United States
• Orlando Health — Orlando, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern Medicine Proton Center — Chicago, Illinois, United States
• Willis Knighton — Shreveport, Louisiana, United States
• University of Maryland — Baltimore, Maryland, United States
• Johns Hopkins — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Mass General/North Shore Cancer Center — Danvers, Massachusetts, United States
• McLaren Proton Therapy — Flint, Michigan, United States
• William Beaumont — Royal Oak, Michigan, United States
• Mayo Clinic-Rochester — Rochester, Minnesota, United States
• Washington University, St. Louis — St Louis, Missouri, United States
• RWJ University Hospital Hamilton — Hamilton, New Jersey, United States
• Cancer Institute of NJ — New Brunswick, New Jersey, United States
• ProCure Proton Therapy Center — Somerset, New Jersey, United States

Full record on ClinicalTrials.gov

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