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Could one zap of radiation replace five for breast cancer?

NCT ID NCT06946238

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 311 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jun 2035

An estimate. End dates often move.

Lead sponsor

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

40 years and older

Sex

Female participants only

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • IRCCS San Raffaele Scientific Institute

    RECRUITING

    Milan, 20132, Italy

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