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

NCT06382818 | Recruiting DMC

• 1 other identifier: PROICM 2023-10 PRO
• Study Type: interventional
• Target: 854
• Locations: 1 country
• Sites: 1

Brief Summary

Our objective is based on a personalized approach of adjuvant breast radiotherapy by selecting patients according to tumor recurrence and toxicity risk.

Conditions

Breast Cancer

Keywords

Radiotherapy breast cancer

Outcome Measures

Primary Outcomes (1)

• Rate of patients without any grade 2 or more fibrosis, nor radio-induced sarcoma

  Toxicity free survival is defined as the interval between date of inclusion and the occurrence of fibrosis grade 2 or more or radio-induced sarcoma. Patients without event at the analysis will be censored at the date of last follow-up.

  at 10 years

Secondary Outcomes (6)

• Acute toxicity

  from the start of RT to 12 weeks post RT

• Late toxicity

  from 12 weeks post RT to 3, 5 and 10 years post RT

• Local recurrence rate (LRR)

  at 3, 5, 10 years

• Relapse-free survival (RFS) rate

  at 3, 5, 10 years

• Overall survival (OS) rate

  at 3, 5, 10 years:

Study Arms (4)

COHORT A

OTHER

In this cohort, the patients with low risk of recurrence and a low risk of breast toxicity

Radiation: COHORT A

COHORT B

OTHER

For this cohort, patients with low risk of recurrence and a high risk of breast toxicity, will receive breast radiotherapy according to the investigator's decision among: * External partial : 40 Gy in 15 fractions to the partial breast only (tumorectomy bed). * Exclusive Brachytherapy: 30.1 Gy in 7 fractions or 32.0 Gy in 8 fractions of high-dose-rate brachytherapy in 5 days or as 50 Gy of pulsed-dose-rate brachytherapy over 5 treatment days. * Whole Breast Normo fractionated with Fixed Field Intensity Modulated radiotherapy(IMRT) Technique: 50 Gy in 25 daily fractions over 5 weeks +/- Sequential (+ 16 Gy/8fr) or SIB (simultaneous integrated boost) (60 Gy/25 fr) treatment for boost if applicable.

Radiation: COHORT B

COHORT C

OTHER

For this cohort, patients with high risk of recurrence and a low risk of breast toxicity, will receive whole breast and nodes Hypofractionated VMAT and a localized simultaneous boost according to the HypoG01 schema protocol: VMAT Technique, 42.3 Gy in 18 fractions on all target volume on 3.5 weeks +/- SIB boost if need (52.2Gy in 18 fractions).

Radiation: COHORT C

COHORT D

OTHER

For this cohort, patients with high risk of recurrence and a high risk of breast toxicity, will receive breast radiotherapy based on available clinical trials: \- Whole Breast and Nodes Hypofractionated VMAT with adaptive treatment (margin reduction): HypoG01 Schema with VMAT Technique, 42.3 Gy in 18 fractions on all target volume over 3.5 weeks +/- SIB boost if need (52.2Gy in 18 fr) In case of patient refusal or technique unavailable, a standard treatment available in the center for this indication will be delivered.

Radiation: COHORT D

Interventions

COHORT B RADIATION

Breast radiotherapy according to the investigator's decision among: * External partial VMAT: 40 Gy in 15 fractions to the partial breast only (tumorectomy bed). * Exclusive Brachytherapy: 30.1 Gy in 7 fractions or 32.0 Gy in 8 fractions of high-dose-rate brachytherapy in 5 days or as 50 Gy of pulsed-dose-rate brachytherapy over 5 treatment days. * Whole Breast Normo fractionated IMRT with Fixed Field IMRT Technique: 50 Gy in 25 daily fractions over 5 weeks +/- Sequential (+ 16 Gy/8fr) or SIB (60 Gy/25 fr) treatment for boost if applicable.

COHORT B

COHORT C RADIATION

Whole breast and nodes Hypofractionated VMAT and a localized simultaneous boost according to the HypoG01 schema protocol: VMAT Technique, 42.3 Gy in 18 fractions on all target volume on 3.5 weeks +/- SIB boost if need (52.2Gy in 18 fractions).

COHORT C

COHORT D RADIATION

Breast radiotherapy based on available clinical trials: \- Whole Breast and Nodes Hypofractionated VMAT with adaptive treatment (margin reduction): HypoG01 Schema with VMAT Technique, 42.3 Gy in 18 fractions on all target volume over 3.5 weeks +/- SIB boost if need (52.2Gy in 18 fr) In case of patient refusal or technique unavailable, a standard treatment available in the center for this indication will be delivered.

COHORT D

COHORT A RADIATION

IMRT radiotherapy on whole breast according to the investigator's decision among: * Moderate whole breast hypofractionated RT according to the START B schema with Fixed Field IMRT Technique: 40.05 Gy in 15 daily fractions over 3 weeks and a Sequential boost (+ 16 Gy/8 fr) or (+13.5/5 fr) if applicable. * Extreme whole breast hypofractionated RT according to : * The FAST schema: Once-a-week ultra-HypoRT with Fixed Field IMRT Technique, 28.5 Gy in 5 fractions in 5 weeks * The FAST-Forward schema: Very accelerated course of HypoRT with Fixed Field IMRT Technique, 26 Gy in 5 fractions in 5 consecutive days

COHORT A

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General criteria (for all cohorts):
• Women ≥ 18 years old.
• Invasive breast cancer treated by conservative or radical surgery.
• Conservative breast cancer surgery or radical mastectomy.
• Indication of breast irradiation.
• Extension evaluation of disease will be proven negative (M0).
• 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.
• Effective contraception for women of childbearing age
• Must be geographically accessible for follow-up.
• Written and dated informed consent.
• 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)

You may not qualify if:

• \. Patients with distant metastases.
• \. 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.
• \. Patients with other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, etc.) which would prevent prolonged follow-up.
• \. Patients known to be HIV positive (no specific tests are required to determine the eligibility).
• \. 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

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Institut Du Cancer de Montpellier

Montpellier, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• AZRIA DAVID

  Institut du Cancer de Montpellier - Val d'Aurelle

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MOUSSION AURORE

CONTACT

0467613102; aurore.moussion@icm.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * COHORT A = Low risk of recurrence / Low risk of breast toxicity * COHORT B = Low risk of recurrence / High risk of breast toxicity * COHORT C = High risk of recurrence / Low risk of breast toxicity * COHORT D = High risk of recurrence / High risk of breast toxicity

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: March 6, 2025
• Primary Completion (Estimated): March 6, 2028
• Study Completion (Estimated): March 6, 2038
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)