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New radiation technique aims to spare heart in breast cancer patients

NCT ID NCT01758445

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study is testing a precise type of radiation called proton therapy for women with stage II or III breast cancer who need radiation to the whole breast or chest wall and lymph nodes. The goal is to see if this approach causes fewer side effects, especially to the heart, compared to standard radiation. About 220 participants will be followed for up to 15 years to track heart health and risk of new cancers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Proton radiotherapy
What this could lead to
If successful, this could offer a safer radiation option for advanced breast cancer, lowering the risk of heart problems and second cancers later in life.
What could go wrong
This is a mid-stage trial with 220 participants, so results are not yet proven. Long-term benefits and risks (like heart issues or new cancers) will take 10-15 years to fully assess.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 220 people

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

Start date

Feb 2013

Expected to finish

Jan 2032

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Ages

18 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: 1. Must sign study-specific, IRB approved informed consent form prior to study entry. Note consent by legally authorized representative is not allowed for this trial. 2. Must be \> = 18 years of age. 3. Must have a life expectancy of at least 10 years based on age and comorbidities but excluding diagnosis of breast cancer. 4. Must have pathology proven breast cancer. Pathology must be invasive ductal or lobular 5. Must meet stage II - III group criteria per AJCC Staging manual 7th edition. 6. Must have had surgical treatment of the breast - either mastectomy or breast preserving surgery, such as lumpectomy. Re-excision of surgical margins is permitted. 7. Note: Multicentric breast cancer and Paget's disease of the nipple are permitted. Exclusion Criteria: 1. Weight over 410 pounds. 2. Non-epithelial breast malignancies such as sarcoma or lymphoma. 3. Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re-excision, the patient is eligible). 4. Breast size exceeding the technical limitation of daily set-up reproducibility. This may be center-specific and will be assessed at the discretion of the treating center. 5. Women with post-surgical temporary breast expanders will require individual assessment. Depending on the manufacturing product and other treatment planning-specific details the patient may be eligible or may be deemed ineligible, as determined by treating investigator. 6. Prior history of breast cancer. 7. Prior radiation to the breast or thorax. 8. Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma. 9. Pregnancy or lactation at the time of proposed study entry. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy such as an intrauterine device or condom with spermicide. (Note: Women of childbearing potential must have a negative serum pregnancy test within 3 weeks of study registration). 10. Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements. 11. Prior history of non-breast malignancies unless they have been disease free for 5 or more years and are deemed by their physician to be at low risk for recurrence. Further, patients who have the following cancers treated within the prior 5 years are permitted: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, basal cell or squamous cell carcinoma of the skin.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Hampton University Proton Therapy Institute

    Hampton, Virginia, 23666, United States

  • Maryland Proton Treatment Center

    Baltimore, Maryland, 21201, United States

  • Northwestern Medicine Chicago Proton Center

    Warrenville, Illinois, 60555, United States

  • Oklahoma Proton Center

    Oklahoma City, Oklahoma, 73142, United States

  • Princeton ProCure Managment LLC

    Somerset, New Jersey, 08873, United States

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