Single‑session targeted partial breast radiation with a simultaneous boost for early-stage favorable‑subtype 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 randomized, monocentric, non‑inferiority trial comparing a single‑fraction stereotactic accelerated partial breast irradiation (APBI) of 15.5 Gy with a simultaneous integrated boost to 21 Gy versus the department's standard APBI of 30 Gy delivered in five consecutive fractions (Florence protocol). Eligible patients are those with pathological stage pTis–pT2 (≤3 cm), node‑negative status, negative surgical margins, and luminal A or B HER2‑negative histology following breast‑conserving surgery. Treatments target the planning target volume (PTV) of the tumor bed with stereotactic techniques and the boost is directed to the gross tumor volume (GTV) representing the tumor bed. The trial will track local control, acute and late toxicity, and cosmetic outcomes over follow‑up to determine whether the single‑fraction approach is non‑inferior to the multifraction standard.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Histological diagnosis of breast cancer
2. Patients aged ≥40 years
3. Signed informed consent
4. Stage pTis-T2, up to 3 cm in the greatest diameter
5. Luminal A and Luminal B HER2-negative histological subtypes
6. Negative surgical margins (≥ 0.2 cm)
7. Negative lymph nodes at sentinel lymph node biopsy, or alternatively with imaging tests (Positron Emission Tomography (PET)/Computed Tomography (CT) and/or axillary ultrasound, and/or breast Magnetic Resonance Imaging (MRI) with and without contrast), or, in rare cases, where still performed, with axillary dissection
8. Clinical M0 (PET/CT and/or bone scintigraphy and/or abdomen-pelvis CT with and without contrast in suspected patients), within the previous 3 months.
9. Performance Status (PS) Eastern Cooperative Oncology Group (ECOG) ≤2
10. No prior thoracic radiotherapy
11. Fertile women using contraception methods initiated during oncological treatment.

Exclusion Criteria:

1. Patients aged \< 40 years
2. Tumors \> 3 cm
3. Multicentric tumors
4. Positive or close surgical margins (\<0.2 cm)
5. Lobular carcinoma
6. Negative hormone receptors
7. HER2-positive
8. BReast CAncer (BRCA) genes BRCA1 and/or BRCA2 positive (only if known)
9. Severe systemic diseases
10. Psychiatric or other disorders that may prevent the patient from signing informed consent
11. Previous invasive cancer, except for skin cancer (excluding melanoma) unless the patient has been disease-free for at least 3 years (e.g., carcinoma in situ of the oral cavity or bladder)
12. Collagen or autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, scleroderma, Sjogren's syndrome)
13. Lymph node disease (N1)
14. Evidence of distant metastasis (M1)
15. Contraindication to systemic treatment
16. Pregnant women
17. 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.