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

Conditions Phase Intervention Type


Ages Eligible for Study
21 years and up
Genders Eligible for Study



Patient-Centered Outcomes Research Institute
University of Pennsylvania

Inclusion Criteria

- 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

- 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.

Exclusion Criteria

- 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

- Any radiation therapy for the currently diagnosed breast cancer prior to

- Dermatomyositis with a CPK level above normal or with an active skin rash or

- Other non-malignant systemic disease that would preclude the patient from receiving
study treatment or would prevent required follow-up.

Detailed Description

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 November, 2020,

Contacts and Locations

Please refer to this study by its identifier: NCT02603341


  • Pinnacle Health Cancer Institute
    Harrisburg, Pennsylvania United States

    Status: Recruiting

    Contact info David Weksberg, MD, PhD
  • Miami Cancer Insititute
    Miami, Florida United States

    Status: Recruiting

    Contact info Marcio Fagundes, MD
  • Orlando Health
    Orlando, Florida United States

    Status: Recruiting

    Contact info Tomas Dvorak, MD
  • UC San Diego
    San Diego, California United States

    Status: Recruiting

    Contact info James Urbanic, MD
  • Provision Center for Proton Therapy
    Knoxville, Tennessee United States

    Status: Recruiting

    Contact info Allen Meeks, MD
  • Washington University, St. Louis
    Saint Louis, Missouri United States

    Status: Recruiting

    Contact info Imran Zoberi, MD
See 21 more locations

Overall Contact

Hien Lu

Overall Contact Backup

Justin Bekelman, MD