AzTrials
AzTrials

Breast CancerNCT02603341

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

A study testing Photon and Proton in people with Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 40 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Photon and Proton
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,238 participants
Where
40 sitesUnited States
Study dates
6 Apr 2016to Nov 2036
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

United States40 sites

  • Emory University

    Atlanta, Georgia, 30322

  • University of Maryland

    Baltimore, Maryland, 21201

  • Johns Hopkins

    Baltimore, Maryland, 21287

  • University of Alabama

    Birmingham, Alabama, 35233

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Northwestern Medicine Proton Center

    Chicago, Illinois, 60190

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • University Hospitals, Case Medical Center

    Cleveland, Ohio, 44106

  • University of Miami Sylvester Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

  • Mass General/North Shore Cancer Center

    Danvers, Massachusetts, 01923

  • University of Miami Sylvester Cancer Center - Deerfield

    Deerfield Beach, Florida, 33442

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • McLaren Proton Therapy

    Flint, Michigan, 48532

  • University of Florida Health

    Gainesville, Florida, 32610

  • RWJ University Hospital Hamilton

    Hamilton, New Jersey, 08690

  • Pinnacle Health Cancer Institute

    Harrisburg, Pennsylvania, 17109

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Texas Center for Proton Therapy

    Irving, Texas, 75063

  • University of Florida Health Proton Therapy Institute

    Jacksonville, Florida, 32206

  • Thompson Proton Center

    Knoxville, Tennessee, 37909

  • University of Miami Sylvester Cancer Center

    Miami, Florida, 33136

  • Miami Cancer Insititute

    Miami, Florida, 33176

  • Cancer Institute of NJ

    New Brunswick, New Jersey, 08903

  • New York Proton Center

    New York, New York, 10035

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Oklahoma University - Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Orlando Health

    Orlando, Florida, 32806

  • Abramson Cancer Center at Penn Medicine

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic-Arizona

    Phoenix, Arizona, 85054

  • Mayo Clinic-Rochester

    Rochester, Minnesota, 55905

  • William Beaumont

    Royal Oak, Michigan, 48073

  • UC San Diego

    San Diego, California, 92121

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98133

  • University of Washington

    Seattle, Washington, 98195

  • Willis Knighton

    Shreveport, Louisiana, 71103

  • ProCure Proton Therapy Center

    Somerset, New Jersey, 07728

  • Washington University, St. Louis

    St Louis, Missouri, 63110

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • University Pointe, University of Cincinnati

    West Chester, Ohio, 45069

  • Chester County Hospital

    West Chester, Pennsylvania, 19380

Other trials in United States

About this study

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.

Read the detailed description

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.

Conditions
Breast Cancer
Being tested
Photon, Proton
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PhotonRadiation

    Photon Therapy:once a day, 5 days a week, for 5 to 7 weeks

  • ProtonRadiation

    Proton Therapy: once a day, 5 days a week, for 5 to 7 weeks

Study groups in NCT02603341
Study groupRoleWhat they receive
PhotonActive comparatorPhoton therapy: once a day, 5 days a week, for 5 to 7 weeks
Receives: Radiation: Photon
ProtonActive comparatorProton therapy: once a day, 5 days a week, for 5 to 7 weeks
Receives: Radiation: Proton

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 10 years

Secondary outcomes (4)

  1. 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)

    Measured: 5 years

  2. 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.

    Measured: 5 years

  3. 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.

    Measured: 5 years

  4. Long Term Survival

    To assess longer-term rates of breast cancer specific and overall survival and development of second malignancies.

    Measured: 15 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2015 (estimated)
  2. Study start6 Apr 2016
  3. Primary completionNov 2036 (estimated)
  4. Study completionNov 2036 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,238 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02603341
Sponsor's protocol ID
UPCC 19115
Status last verified
Nov 2025
First submitted
9 Nov 2015
Last updated
6 Nov 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Hahn EA, Pugh SL, Lu HL, Vela AM, Gillespie EF, Nichols EM, Wright JL, MacDonald SM, Cahlon O, Baas C, Braunstein LZ, Fang LC, Freedman GM, Jimenez RB, Kesslering CM, Mishra MV, Mutter RW, Ohri N, Rosen LR, Urbanic JJ, Jagsi R, Mitchell SA, Bekelman JE, Cella D; Study Group Investigators:. Validation of Patient-Reported Outcomes in Patients With Nonmetastatic Breast Cancer Receiving Comprehensive Nodal Irradiation in the RadComp Trial. Int J Radiat Oncol Biol Phys. 2024 Sep 1;120(1):149-161. doi: 10.1016/j.ijrobp.2024.03.020. Epub 2024 May 13.

    PubMed 38739047

  • Bekelman JE, Lu H, Pugh S, Baker K, Berg CD, Berrington de Gonzalez A, Braunstein LZ, Bosch W, Chauhan C, Ellenberg S, Fang LC, Freedman GM, Hahn EA, Haffty BG, Khan AJ, Jimenez RB, Kesslering C, Ky B, Lee C, Lu HM, Mishra MV, Mullins CD, Mutter RW, Nagda S, Pankuch M, Powell SN, Prior FW, Schupak K, Taghian AG, Wilkinson JB, MacDonald SM, Cahlon O; RadComp (Radiotherapy Comparative Effectiveness Consortium). Pragmatic randomised clinical trial of proton versus photon therapy for patients with non-metastatic breast cancer: the Radiotherapy Comparative Effectiveness (RadComp) Consortium trial protocol. BMJ Open. 2019 Oct 15;9(10):e025556. doi: 10.1136/bmjopen-2018-025556.

    PubMed 31619413

Questions about this trial

What is this clinical trial studying?

A study testing Photon and Proton in people with Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 40 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness of proton therapy vs. photon therapy (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02603341, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in