New radiation technique aims to spare heart in breast cancer patients
NCT ID NCT01758445
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Breast cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a faster radiation course match the standard one after breast reconstruction?
- Can High-Risk breast cancer patients skip an extra radiation boost?
- Radioactive probe lights up CD73 on breast tumors in PET scans
- Can time with horses help cancer patients feel better?
- Can an oral drug replace injections for advanced breast cancer?
- Can a common steroid shield breast cancer patients from a dangerous drug side effect?