New radiation schedule before breast surgery shows promise in small trial
NCT ID NCT03624478
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tested giving a higher dose of radiation over fewer sessions (hypofractionated radiotherapy) to the whole breast before surgery in 25 women with early-stage breast cancer. The goal was to see if this approach could kill more tumor cells and cause fewer side effects compared to standard radiation. Researchers measured how many patients had no cancer left in the surgical specimen (pathologic complete response) and tracked any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Hypofractionated radiation therapy
- What this could lead to
- If successful, this approach could offer a more convenient and effective radiation schedule before breast cancer surgery, potentially reducing side effects and improving tumor clearance.
- What could go wrong
- This is a small, early-phase trial with only 25 participants, so results may not apply broadly. The higher radiation dose could also increase short-term side effects.
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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25 people
The number who actually took part.
- Started
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Nov 2018
- Finished
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Sep 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- 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: * Histological confirmation of breast cancer * Clinical stage T0-T2 N0 M0 * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2 * Able to and provides Institutional Review Board (IRB) approved study specific written informed consent * Study entry must be within 120 days of last biopsy (breast) * Able to complete all mandatory tests * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) * Planned breast surgery and indications for whole breast radiotherapy Exclusion Criteria: * Medical contraindication to receipt of radiotherapy * Severe active co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or providing informed consent * Active systemic lupus or scleroderma * Pregnancy * Women of childbearing potential who are unwilling to employ adequate contraception * Prior receipt of ipsilateral breast or chest wall radiation * Recurrent breast cancer * Indications for comprehensive regional nodal irradiation * No neo-adjuvant therapy
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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
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
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Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
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