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New study tests if proton therapy spares hearts in breast cancer patients

NCT ID NCT02603341

Disease control Sponsor: Abramson Cancer Center at Penn Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two types of radiation therapy—proton and photon—for people with non-metastatic breast cancer. The goal is to see if proton therapy reduces heart problems and improves quality of life while still controlling the cancer. About 1,200 participants who had surgery for breast cancer are being followed for years to track heart health, cancer recurrence, and daily well-being.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,238 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2016

Expected to finish

Nov 2036

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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. 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 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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Abramson Cancer Center at Penn Medicine

    Philadelphia, Pennsylvania, 19104, United States

  • Cancer Institute of NJ

    New Brunswick, New Jersey, 08903, United States

  • Chester County Hospital

    West Chester, Pennsylvania, 19380, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007, United States

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031, United States

  • Johns Hopkins

    Baltimore, Maryland, 21287, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Mass General/North Shore Cancer Center

    Danvers, Massachusetts, 01923, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic-Arizona

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic-Rochester

    Rochester, Minnesota, 55905, United States

  • McLaren Proton Therapy

    Flint, Michigan, 48532, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Miami Cancer Insititute

    Miami, Florida, 33176, United States

  • New York Proton Center

    New York, New York, 10035, United States

  • Northwestern Medicine Proton Center

    Chicago, Illinois, 60190, United States

  • Oklahoma University - Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104, United States

  • Orlando Health

    Orlando, Florida, 32806, United States

  • Pinnacle Health Cancer Institute

    Harrisburg, Pennsylvania, 17109, United States

  • ProCure Proton Therapy Center

    Somerset, New Jersey, 07728, United States

  • RWJ University Hospital Hamilton

    Hamilton, New Jersey, 08690, United States

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98133, United States

  • Texas Center for Proton Therapy

    Irving, Texas, 75063, United States

  • Thompson Proton Center

    Knoxville, Tennessee, 37909, United States

  • UC San Diego

    San Diego, California, 92121, United States

  • University Hospitals, Case Medical Center

    Cleveland, Ohio, 44106, United States

  • University Pointe, University of Cincinnati

    West Chester, Ohio, 45069, United States

  • University of Alabama

    Birmingham, Alabama, 35233, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Florida Health

    Gainesville, Florida, 32610, United States

  • University of Florida Health Proton Therapy Institute

    Jacksonville, Florida, 32206, United States

  • University of Maryland

    Baltimore, Maryland, 21201, United States

  • University of Miami Sylvester Cancer Center

    Miami, Florida, 33136, United States

  • University of Miami Sylvester Cancer Center - Deerfield

    Deerfield Beach, Florida, 33442, United States

  • University of Miami Sylvester Cancer Center at Coral Gables

    Coral Gables, Florida, 33146, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Washington University, St. Louis

    St Louis, Missouri, 63110, United States

  • William Beaumont

    Royal Oak, Michigan, 48073, United States

  • Willis Knighton

    Shreveport, Louisiana, 71103, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.