5 fr Ultrahypofractionated WBI and SIB for Breast Cancer With Unfavorable Characteristics
Recruiting · NCT07020780 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Adjuvant 5 fractions whole breast irradiation with simultaneous integrated boost to the tumor bed
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.
Who can take part
Age range
18 Years to 70 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- IRCCS San Raffaele Scientific Institute - Milan, Italy