Actively Recruiting
5 fr Ultrahypofractionated WBI and SIB for Breast Cancer With Unfavorable Characteristics
Led by IRCCS San Raffaele · Updated on 2025-07-28
458
Participants Needed
1
Research Sites
518 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 integrated boost (SIB) to the tumor bed to a total dose of 30 Gy, and WBI to a total dose of 40.05 Gy in 15 fractions with SIB to the tumor bed to a total dose of 48 Gy (standard treatment), for young or unfavorable breast cancer patients.
CONDITIONS
Official Title
5 fr Ultrahypofractionated WBI and SIB for Breast Cancer With Unfavorable Characteristics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological diagnosis of breast cancer
- Younger than 40 years regardless of tumor subtype, or age 40 to 70 with lobular carcinoma, Luminal B Her2 positive, hormone receptor-negative Her2 positive, or triple negative breast cancer
- Signed informed consent
- Clinical stage T1 to T3, Nx to N3
- Negative surgical margins of at least 0.2 cm
- No distant metastases in past 3 months
- Performance status (ECOG) 0 to 2
- No previous chest radiotherapy
- Fertile women using contraception started during treatment
You will not qualify if you...
- Favorable characteristics (Luminal A, Luminal B Her2 negative, age 40 or older) receiving partial irradiation
- Patients who had mastectomy
- Multicentric tumors
- Positive or close surgical margins under 0.2 cm
- Known BRCA1/2 positive
- Serious systemic diseases
- Mental or other disorders preventing consent
- Previous invasive tumor except certain skin cancers unless disease-free for 3 years
- Collagen or autoimmune diseases such as lupus, rheumatoid arthritis, scleroderma, Sjogren's syndrome
- Evidence of distant metastases
- Contraindication to systemic treatment
- Pregnant women
- Not following dose limits in treatment plan
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCCS San Raffaele Scientific Institute
Milan, Italy, 20132
Actively Recruiting
Research Team
A
Andrei Fodor, MD
CONTACT
R
Roberta Tummineri, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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