Status:
RECRUITING
5 fr Ultrahypofractionated WBI and SIB for Breast Cancer With Unfavorable Characteristics
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
This is a prospective, randomized, single-center, non-inferiority interventional clinical trial comparing whole breast irradiation (WBI) to a total dose of 26 Gy in 5 fractions with simultaneous integ...
Detailed Description
The project refers to a study on patients with T1-T3 Nx-N3 breast cancer, aged under 40 years or with unfavorable histology (lobular carcinoma, multifocal tumor, or histological subtypes Luminal B Her...
Eligibility Criteria
Inclusion Criteria:
- Histological diagnosis of breast cancer
- Patients younger than 40 years regardless of histological subtype, or patients between 40 and 70 years with lobular carcinoma, histological subtypes Luminal B Her2 positive, or with hormone receptors negative and Her2 positive (ErbB2), or triple negative (TNBC)
- Signed informed consent
- Clinical stage T1-T3, Nx-N3
- Negative surgical margins (≥ 0.2 cm)
- Clinical M0 in the previous 3 months
- PS (ECOG) ≤2
- No previous thoracic radiotherapy
- Fertile women using contraceptive methods started during oncological treatment
Exclusion Criteria:
- Patients with favorable characteristics (Luminal A, Luminal B Her2 negative, ≥ 40 years) undergoing partial irradiation
- Patients who have undergone mastectomy
- Multicentric tumors
- Positive or close surgical margins (<0.2 cm)
- BRCA1/2 positive (only if known)
- Serious systemic diseases
- Mental or other disorders that may prevent the patient from signing the informed consent
- Previous invasive tumor, except skin cancer (excluding melanoma) unless the patient has been disease-free for at least 3 years (for example carcinoma in situ of the oral cavity or bladder)
- Collagen or autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, scleroderma, Sjogren's syndrome)
- Evidence of distant metastases (M1)
- Contraindication to treatment systemic
- Pregnant women
- Non-compliance with the dose limits established in the treatment plan
Key Trial Info
Start Date :
July 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2035
Estimated Enrollment :
458 Patients enrolled
Trial Details
Trial ID
NCT07020780
Start Date
July 25 2025
End Date
June 30 2035
Last Update
July 28 2025
Active Locations (1)
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1
IRCCS San Raffaele Scientific Institute
Milan, Italy, 20132