5‑fraction whole‑breast radiation with a simultaneous boost versus standard 15‑fraction radiation for younger or unfavorable breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, single‑center non‑inferiority trial comparing an ultrahypofractionated schedule (26 Gy in 5 fractions with a simultaneous integrated boost to 30 Gy) to the department’s standard moderately hypofractionated regimen (40.05 Gy in 15 fractions with SIB to 48 Gy). Eligible patients have T1–T3, Nx–N3 disease, underwent breast‑conserving surgery with negative margins, and are either under 40 years or aged 40–70 with unfavorable histology (lobular, Luminal B HER2‑positive, HR‑negative HER2‑positive, or triple‑negative). Radiotherapy may include regional lymph node areas as indicated, and participants are randomized to one of the two schedules for adjuvant whole‑breast irradiation. The trial tests whether the shorter 5‑fraction approach provides comparable local control and safety while offering greater convenience.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Histological diagnosis of breast cancer
2. 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)
3. Signed informed consent
4. Clinical stage T1-T3, Nx-N3
5. Negative surgical margins (≥ 0.2 cm)
6. Clinical M0 in the previous 3 months
7. PS (ECOG) ≤2
8. No previous thoracic radiotherapy
9. Fertile women using contraceptive methods started during oncological treatment

Exclusion Criteria:

1. Patients with favorable characteristics (Luminal A, Luminal B Her2 negative, ≥ 40 years) undergoing partial irradiation
2. Patients who have undergone mastectomy
3. Multicentric tumors
4. Positive or close surgical margins (\<0.2 cm)
5. BRCA1/2 positive (only if known)
6. Serious systemic diseases
7. Mental or other disorders that may prevent the patient from signing the informed consent
8. 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)
9. Collagen or autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, scleroderma, Sjogren's syndrome)
10. Evidence of distant metastases (M1)
11. Contraindication to treatment systemic
12. Pregnant women
13. Non-compliance with the dose limits established in the treatment plan

Where it's running

• IRCCS San Raffaele Scientific Institute
  Milan, Italy Recruiting

Study contacts

• Principal investigator: Andrei Fodor, MD — IRCCS San Raffaele Scientific Institute
• Study coordinator: Andrei Fodor, MD
• Email: fodor.andrei@hsr.it
• Phone: +390226437634

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.