Proton beam zaps breast tumors with less damage?
NCT ID NCT01766297
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests proton radiation therapy for women with early-stage breast cancer. The goal is to see if targeting only the tumor area can keep cancer from coming back while causing fewer side effects. About 132 women aged 50 and older will take part. Researchers will track recurrence, side effects, and quality of life over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Proton radiation therapy
- What this could lead to
- If successful, this could offer a more precise radiation option for early breast cancer, potentially reducing side effects and improving quality of life.
- What could go wrong
- This is a mid-stage trial with a small number of participants. It may not show better outcomes than standard radiation, and long-term side effects are still being studied.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 132 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Feb 2013
- Expected to finish
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Jan 2035
An estimate. End dates often move.
- Lead sponsor
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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
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50 years and older
- Sex
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Female participants only
- Healthy volunteers
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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: * 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. * Must be female. * Must be \> = 50 years of age. * Must have a life expectancy of at least 5 years based on age and co-morbidities. * Must have pathology proven invasive ductal carcinoma (lobular is not allowed) and/or ductal carcinoma in situ (DCIS). * One of the following criteria must be met: (a) Tumors that are microscopically multifocal must be 3.0 cm or less in total aggregate size and encompassed within a single scar (b) Patient does not have microscopically multifocal tumor. * For tumors that are invasive, if in the presence of extensive intraductal component (EIC), the entire pathologic tumor size (including both the intraductal and invasive component) must be 3.0 cm or less. * Must be Stage 0, I, II (Tis, T1, or T2, N0, M0 per AJCC criteria 7th and/or 8th Ed.). If stage II, the tumor size must be \< = 3.0 cm. A patient with invasive histology must have nodal stage pN0 by H\&E stains on sentinel node biopsy or axillary lymph node dissection. * Must have ER positive disease with ER/PR report available. * For tumors that are invasive, HER2 must be performed (positive or negative is acceptable). * Must have a lumpectomy performed, with documented negative surgical margins by 0.2 cm or more. If re-excision results in negative surgical margins 0.2 cm or more, patient is eligible. * If image guidance with daily cone beam CT with direct physician visual assessment is used for treatment positioning, the presence of markers or clips in the surgical bed is recommended but not required. If cone beam CT imaging will NOT be used for image guidance, then the patient must be prepared to have 2 fiducial markers minimum, 3 preferred, placed prior to treatment (if not previously done). * If markers or clips were placed at the time of surgery, patient must be able to start treatment within 12 weeks after lumpectomy or re-excision for adequate margins. * If markers were not placed at the time of surgery and are needed, patient must have markers placed within 6 weeks after surgery. * If systemic chemotherapy was given, patient must have had clips or markers placed at the time of surgery (if they are needed) and patient must have simulation scans within 6 weeks of the completion of the chemotherapy. * Must be able to start treatment within 12 weeks of surgery or 8 weeks of finalization of chemotherapy. Exclusion Criteria: * Previous history of ipsilateral invasive breast cancer or DCIS. * Any clinical or radiographically suspicious nodes, unless biopsy proven benign. * Non-epithelial malignancies such as sarcoma or lymphoma. * Suspicious residual microcalcifications on mammography of either breast, unless negative for malignancy on pathology. * Multicentric or bilateral disease unless biopsy of the clinical abnormalities are performed and result is negative. * Lymphovascular space invasion (LVSI) on pathology specimen. * Any previously treated breast carcinoma or synchronous breast carcinoma in ipsilateral breast. * Prior radiation therapy to the ipsilateral breast or thorax. * Paget's disease of the nipple. * Histologic examination showing invasive lobular histology. * Skin involvement. * Breasts technically unsatisfactory for radiation treatment upon the discretion of the treating physician. * Significant infection or other co-existing medical condition that would preclude protocol therapy such as pregnancy, HIV/AIDS or collagen vascular diseases specifically systemic lupus erythematosus, scleroderma, or dermatomyositis. * Known BRCA 1 or BRCA 2 mutation. * Pregnant or lactating.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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California Protons Cancer Therapy Center
RECRUITINGSan Diego, California, 92121, United States
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Hampton University Proton Therapy Institute
RECRUITINGHampton, Virginia, 23666, United States
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Inova Schar Cancer Institute
RECRUITINGFairfax, Virginia, 22031, United States
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Maryland Proton Treatment Center
RECRUITINGBaltimore, Maryland, 21201, United States
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Mayo Clinic
RECRUITINGScottsdale, Arizona, 85259, United States
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McLaren Proton Therapy Center
RECRUITINGFlint, Michigan, 48532, United States
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New York Proton Center
RECRUITINGNew York, New York, 10035, United States
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Northwestern Medicine Chicago Proton Center
RECRUITINGWarrenville, Illinois, 60555, United States
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Oklahoma Proton Center
RECRUITINGOklahoma City, Oklahoma, 73142, United States
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