Could one zap of radiation replace five for breast cancer?
NCT ID NCT06946238
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares a single, high-dose radiation treatment to the standard five-session approach for women with early-stage breast cancer. The goal is to see if the one-time treatment controls cancer just as well while reducing side effects and visits. Participants must be 40 or older with specific low-risk tumor types.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 311 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jun 2035
An estimate. End dates often move.
- 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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40 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Histological diagnosis of breast cancer 2. Patients aged ≥40 years 3. Signed informed consent 4. Stage pTis-T2, up to 3 cm in the greatest diameter 5. Luminal A and Luminal B HER2-negative histological subtypes 6. Negative surgical margins (≥ 0.2 cm) 7. Negative lymph nodes at sentinel lymph node biopsy, or alternatively with imaging tests (Positron Emission Tomography (PET)/Computed Tomography (CT) and/or axillary ultrasound, and/or breast Magnetic Resonance Imaging (MRI) with and without contrast), or, in rare cases, where still performed, with axillary dissection 8. Clinical M0 (PET/CT and/or bone scintigraphy and/or abdomen-pelvis CT with and without contrast in suspected patients), within the previous 3 months. 9. Performance Status (PS) Eastern Cooperative Oncology Group (ECOG) ≤2 10. No prior thoracic radiotherapy 11. Fertile women using contraception methods initiated during oncological treatment. Exclusion Criteria: 1. Patients aged \< 40 years 2. Tumors \> 3 cm 3. Multicentric tumors 4. Positive or close surgical margins (\<0.2 cm) 5. Lobular carcinoma 6. Negative hormone receptors 7. HER2-positive 8. BReast CAncer (BRCA) genes BRCA1 and/or BRCA2 positive (only if known) 9. Severe systemic diseases 10. Psychiatric or other disorders that may prevent the patient from signing informed consent 11. Previous invasive cancer, except for skin cancer (excluding melanoma) unless the patient has been disease-free for at least 3 years (e.g., carcinoma in situ of the oral cavity or bladder) 12. Collagen or autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, scleroderma, Sjogren's syndrome) 13. Lymph node disease (N1) 14. Evidence of distant metastasis (M1) 15. Contraindication to systemic treatment 16. Pregnant women 17. Non-compliance with the dose limits established in the treatment plan
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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
1 site. 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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IRCCS San Raffaele Scientific Institute
RECRUITINGMilan, 20132, Italy
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Other studies related to the condition(s) this trial covers.
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