Could 3 weeks of proton therapy be as safe as 5 for breast cancer?
NCT ID NCT05856773
First seen Jun 26, 2026 · Last updated Jul 10, 2026 · Updated 1 time
Summary
This study compares a 3-week course of proton radiation to the standard 5-week course for women with breast cancer who need radiation to the breast or chest wall and nearby lymph nodes. The goal is to see if the shorter schedule causes fewer severe skin and tissue side effects while still controlling the cancer. About 276 participants will be enrolled.
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 (pencil beam scanning)
- What this could lead to
- If successful, this could offer a shorter, more convenient radiation schedule for breast cancer patients with fewer severe skin and soft tissue side effects.
- What could go wrong
- This is a Phase 3 trial, but results may not apply to all breast cancer types. Shorter radiation could still cause side effects or be less effective at preventing recurrence.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 276 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Feb 2041
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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19 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: * Patients with Stage I-III breast cancer who have undergone breast conserving surgery or mastectomy and have been recommended to receive postoperative radiation therapy to the breast or chest wall and regional draining lymph nodes (axilla levels I-III, SCV, IMN) * Histologically documented breast cancer (invasive mammary, ductal, medullary, tubular, mucinous, lobular, or ductal carcinoma in situ) for which treatment with radiation therapy to the breast/chest wall and comprehensive regional lymph nodes including the internal mammary chain is recommended * Documentation of negative metastatic workup by whole body Positron Emission Tomography - Computed Tomography (PET/CT) or by combined CT of the chest, abdomen, pelvis and Bone scan * History and physical exam within 90 days prior to study registration * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 * Negative pregnancy test for women of child-bearing potential * Able to begin radiation treatment within 12 weeks of last surgery or last day of chemotherapy * Presence of breast implants, breast expanders, tissue flap, or other breast reconstruction are allowed * Bilateral breast cancer is allowed if at least one side will be treated with comprehensive nodal irradiation per protocol treatment and will be recorded as the laterality receiving comprehensive nodal irradiation. If both sides will be treated comprehensively, it will be documented as such Exclusion Criteria: * Presence of skin ulceration and / or ipsilateral satellite nodules and/or edema (including peau d'orange) (T4b or T4c disease) or diagnosis of inflammatory breast cancer (T4d disease) * Residual gross disease detected by imaging or clinical exam with the exception of \<2cm internal mammary lymph node or supraclavicular lymph node amenable to sequential boost * Prior history of radiation therapy overlapping with current target volume (including intraoperative brachytherapy, interstitial catheter brachytherapy, balloon brachytherapy, external beam radiation therapy) * Prior history of explant surgery or implant removal due to infection or wound healing issues without subsequent implant or flap reconstruction * Presence of double/dual port tissue expander * Clinical or radiographic evidence of distant metastatic disease * Pregnant or breast-feeding females * Non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up * History of connective tissue disorder (i.e., systemic lupus erythematosus, scleroderma), dermatomyositis, xeroderma pigmentosum * Known BRCA 1 or BRCA 2 mutation * Presence of an active skin rash * Prior invasive non-study malignancy unless disease free for ≥ 3 years. Non-melanoma skin cancer, well-differentiated thyroid cancers, in situ carcinomas of the oral cavity, cervix, and other organs, and tumors that are not thought to impact the life expectancy of the patient are permissible.
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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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Dwoskin Proton Therapy Center
RECRUITINGMiami, Florida, 33125, United States
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Emory Proton Therapy Center
RECRUITINGAtlanta, Georgia, 30308, 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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Miami Cancer Institute
RECRUITINGMiami, Florida, 33176, United States
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New York Proton Center
RECRUITINGNew York, New York, 10035, United States
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University of Florida Proton Therapy Institute
RECRUITINGJacksonville, Florida, 32206, United States
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Other studies related to the condition(s) this trial covers.
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- Can a common steroid shield breast cancer patients from a dangerous drug side effect?