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Older breast cancer patients given a say in skipping or shortening radiation

NCT ID NCT05058196

Knowledge-focused Sponsor: UNICANCER Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how women aged 65 and older with early-stage breast cancer choose among three options after surgery: standard weeks-long whole-breast radiotherapy, a single dose of radiation during surgery, or no radiation at all. Researchers surveyed 104 patients to understand what influenced their choice and how they experienced the decision. The goal is to help tailor treatment to individual needs and reduce unnecessary radiation in older patients.

What this could mean

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

Active substance
radiotherapy (whole breast or intraoperative)
What this could lead to
If successful, this study could help doctors and patients make more informed decisions about reducing radiation treatment in older women with early breast cancer.
What could go wrong
This is a small, completed observational study, not a treatment trial. It does not test whether de-escalation is safe or effective, only patient preferences.

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

104 people

The number who actually took part.

Started

Oct 2021

Finished

Oct 2025

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

65 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. Patient must have signed a written informed consent form prior to any study specific procedures; when the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor can confirm in writing the patient's consent 2. Women ≥65 years of age 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 4. Clinical stage I, newly diagnosed breast cancer; invasive unifocal HR+ HER2- T1N0 tumour, not lobular, without extensive intraductal component (EIC) (\<25% EIC on biopsy), without embolism on biopsy 5. Eligible to surgery 6. Eligible for both WBRT or IORT 7. Chemotherapy treatment is possible if needed 8. Able to respond to self-report questionnaires in French 9. Affiliated to Social security System Exclusion Criteria: 1. Patient with recurrent breast cancer or inflammatory breast carcinoma 2. Absolute contra-indication to whole-breast irradiation as determined by the referring physician 3. Patient unable to comply with study obligations for geographic, social, or physical reasons, or who is unable to understand the purpose and procedures of the study 4. Patient enrolled in another therapeutic trial. Observational cohorts are accepted if the collection of data does not interfere with the current trial 5. Person deprived of their liberty or under protective custody or guardianship.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Institut Paoli-Calmettes

    Marseille, France

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