New trial aims to customize breast cancer radiation to cut harmful side effects
NCT ID NCT06382818
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether personalizing the dose and schedule of radiation therapy after breast cancer surgery can reduce long-term side effects like scarring (fibrosis) and radiation-induced cancers, while still preventing the cancer from coming back. The trial will enroll 854 women with invasive breast cancer who have had surgery. Doctors will choose from several standard radiation schedules based on each patient's risk of recurrence and side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radiotherapy (IMRT) with different dosing schedules
- What this could lead to
- If successful, this could lead to fewer long-term side effects like fibrosis and sarcoma, while still effectively controlling breast cancer recurrence.
- What could go wrong
- This is a non-randomized study, so results may be less definitive. The personalized approach may not reduce side effects as hoped, and long-term follow-up is needed to confirm safety.
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 854 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Mar 2038
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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18 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: General criteria (for all cohorts): 1. Women ≥ 18 years old. 2. Invasive breast cancer treated by conservative or radical surgery. 3. Conservative breast cancer surgery or radical mastectomy. 4. Indication of breast irradiation. 5. Extension evaluation of disease will be proven negative (M0). 6. Negative pregnancy test (blood or urine at the choice of investigator), to be carried out within 7 days of registration, for women of childbearing age only. 7. Effective contraception for women of childbearing age 8. Must be geographically accessible for follow-up. 9. Written and dated informed consent. 10. Affiliated to the French national social security system. Cohort A and B: \- Low risk of recurrence (all of the criteria) • pT1-T2 * SBR (Scarff Bloom et Richardson grade) grade ≤ 2 (low grade) * ER+ and / or PR+ (hormone-receptor positive) * cN0/pN- * HER 2 - * Ki67 ≤10% pN- with T3-4 and grade 3 and internal tumor will be considered at high risk of recurrence and will be proposed node irradiation (and will be switched to COHORT C or D). Cohort C and D: \- High risk of recurrence (pN+ and at least one of all) adapted from the UK PREDICT • ER- and PR- • HER2 amplified • pT3-4 • SBR grade ≥ 3 * KI67 \> 10% Cohort A and C: * Low risk of breast toxicities identified by the NovaGray RILA Breast® test Cohort B and D: \- High risk of breast toxicities identified by the NovaGray RILA Breast® test Exclusion Criteria: * 1\. Patients with distant metastases. 2\. Patients with breast DCIS (ductal carcinoma in situ) 3. Concomitant bilateral breast cancer 4. Previous breast radiotherapy 5. Patients with previous or concomitant other (not breast cancer) malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for at least five years. 6\. Patients with other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, etc.) which would prevent prolonged follow-up. 7\. Patients known to be HIV positive (no specific tests are required to determine the eligibility). 8\. Patients known as hypersensitive to radiation 9. Patients treated with systemic investigational drugs during the present study (Observational cohorts are accepted if the collection of data does not interfere with the current trial) 10. Pregnant or breast-feeding women 11. 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 12. Person deprived of their liberty or under protective custody or guardianship
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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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Institut Du Cancer de Montpellier
RECRUITINGMontpellier, France
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