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Recruiting Not applicable

5 fr Ultrahypofractionated WBI and SIB for Breast Cancer With Unfavorable Characteristics

NCT07020780 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-07-25
Last updated
2025-07-28

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Adjuvant 5 fractions whole breast irradiation with simultaneous integrated boost to the tumor bed

Adjuvant 5 fractions whole breast irradiation with simultaneous integrated boost to the tumor bed: Experimental arm (arm 1-five fractions WBI) patients will be treated to a total dose (TD) of 26 Gy in 5 fractions to whole breast, and a simultaneous integrated boost (SIB) to a TD of 30 Gy to the tumor bed, while arm 2-fifteen-fractions WBI patients with 40 Gy/15 fractions to PTV, and 48 Gy SIB to the tumor bed.

Study 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 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Local Relapse Free Survival (LRFS) — 5 years
    o demonstrate the non-inferiority of local control (local relapse free survival - LRFS) of the study treatment (delivered in five fractions) compared to the department's standard WBI treatment (delivered in 15 fractions).

Trial sites (1)

FacilityCityRegionStatus
IRCCS San Raffaele Scientific Institute Milan Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07020780 on ClinicalTrials.gov ↗ ← All trials in Italy