Personalizing breast radiation based on risk of recurrence and likely side effects

Personalization of Breast Radiotherapy According to Loco-regional Recurrence Risk and Toxicity Probability

This trial will test whether tailoring post-surgery breast radiation to each woman's risk of the cancer coming back and her chance of treatment side effects can maintain cancer control while reducing unnecessary exposure.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 854 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle (Academic / other)
• Drugs / interventions: radiation, chemotherapy
• Locations: 1 site (Montpellier)
• Trial ID: NCT06382818 on ClinicalTrials.gov

What this trial studies

This interventional protocol groups women into four cohorts (A–D) based on predicted loco-regional recurrence risk and projected toxicity probability, then delivers different radiotherapy approaches accordingly. Radiotherapy options may include standard whole-breast or chest-wall fields, nodal irradiation when indicated, and advanced techniques such as IMRT, partial-breast irradiation, or adaptive planning tailored to each cohort. Eligible adult women have invasive breast cancer, have completed surgery, are M0, and must be able to attend follow-up at the coordinating center. Outcomes will compare local control and treatment-related toxicity between personalized plans and conventional practice.

Who should consider this trial

Good fit: Women aged 18 or older with invasive breast cancer who have had breast-conserving surgery or mastectomy, are M0, have an indication for adjuvant radiotherapy, and meet the cohort-specific pathology and receptor criteria are the intended candidates.

Not a fit: Patients with metastatic disease, those who do not meet the cohort pathology or receptor criteria, pregnant women, or those unable to attend follow-up at the Montpellier center are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the approach could reduce unnecessary radiation and treatment side effects while preserving local cancer control.

How similar studies have performed: Partial-breast irradiation and IMRT have shown benefit in selected groups, but broad personalization using combined recurrence and toxicity models remains a developing and partly untested approach.

Eligibility criteria

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

Where this trial is running

Montpellier

• Institut Du Cancer de Montpellier — Montpellier, France (Recruiting)

Study contacts

• Principal investigator: Azria David — Institut du Cancer de Montpellier - Val d'Aurelle
• Study coordinator: Moussion Aurore

Conditions Breast Cancer; Radiotherapy breast cancer