New radiation technique during breast surgery aims to reduce side effects for seniors
NCT ID NCT04680715
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a new way to give radiation therapy during breast cancer surgery for women aged 65 and older with early-stage breast cancer. The goal is to see if this approach is safe and causes fewer side effects. About 40 participants will receive the treatment and be monitored for up to 6 months for any serious 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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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2021
- Expected to finish
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Jun 2028
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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65 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.
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: * Patient with invasive ductal adenocarcinoma \<=2cm, evaluate on all radiological exams; * Women aged 65 years or older (patients 65 years of age in the year may be included); * Grade 1 or 2 unifocal adenocarcinoma, all index KI67, positive HR, negative HER2 status; * T0 or T1, N0 radio-clinic; * Operable patient with breast volume compatible with conservative surgery; * Patient with prior malignancy or other concurrent malignancies are eligible, including bilateral breast cancer * Patients who have been made aware of the information sheet and have given their written signed informed consent; * Patients benefitting from social health insurance coverage Exclusion Criteria: * Age less than 65 years (except if 65 years obtained during the year) * Patient with an exclusive in situ carcinoma * Patient with lymphatic invasion / peri-nerve involvement / vascular emboli * Patient with a lobular adenocarcinoma * Patient with metastatic disease * Multifocal tumor * Patient with grade 3 or N+ disease * N1 proved by ultrasound guided * patient unable to express her consent * Patient deprived placed under the authority of a tutor * Female patients who are pregnant or breastfeeding * Vulnerable patient: as defined in article L1121-5 à -8
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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
2 sites. 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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Centre Antoine Lacassagne
RECRUITINGNice, 06189, France
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Pôle Santé République
NOT_YET_RECRUITINGClermont-Ferrand, 63000, France
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