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One-Time radiation during surgery could spare older breast cancer patients weeks of treatment

NCT ID NCT04414202

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at giving a single dose of radiation directly to the tumor site during breast-conserving surgery in women aged 60 and older with early-stage, hormone-sensitive breast cancer. The goal is to see if this shorter, targeted approach controls the cancer as well as standard weeks-long whole-breast radiation. Researchers are tracking local relapse rates and cosmetic outcomes in 519 participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
intra-operative partial irradiation (radiation therapy given during surgery)
What this could lead to
If successful, this could offer a shorter, more convenient radiation option for older women with early-stage breast cancer, reducing treatment time from weeks to a single dose.
What could go wrong
This is an observational study, not a randomized trial, so results may not prove the approach is as effective as standard whole-breast radiation. Long-term local relapse rates are still being tracked.

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.

Participants

519 people

The number who actually took part.

Started

Dec 2009

Expected to finish

Dec 2030

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.

Who is studied

Invasive breast cancer with a good prognosis that is accessible to breast-conserving surgery

Ages

60 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: * Women 60 years of age or older, * Histologically proven invasive ductal breast cancer or of a histologically favorable sub-type (mucinous, tubular or colloid), -. Unifocal tumor, * T1 (diameter ≤ 20 mm), * N0 (pN0 or pNi+), * M0, * Gland exeresis margins ≥ 2 mm, * Estrogen receptor positive, * Information and non-opposition of the patient. Exclusion Criteria: -. Inflammatory breast cancer, * Associated peri-tumoral lymphatic emboli * Associated extensive intra-ductal component * Invasive lobular carcinoma * Pure ductal carcinoma in situ, * Sarcoma or lymphoma-type non-epithelial tumor * Synchronous bilateral breast cancer, * Any prior neo-adjuvant treatment: radiotherapy, chemotherapy, hormone 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

  • Icm Val D'Aurelle

    Montpellier, Herault, 34398, France

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Other studies related to the condition(s) this trial covers.