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:

  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

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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IRCCS San Raffaele Scientific Institute

Milan, Italy, 20132