NCT06946238 Single-fraction APBI for Early-stage Breast Cancer With Favorable Histological Subtypes (Breast-1F)
| NCT ID | NCT06946238 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 311 participants |
| Start Date | 2025-07-25 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 311 participants in total. It began in 2025-07-25 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective, randomized, monocentric, non-inferiority interventional clinical study comparing an Accelerated Partial Breast Irradiation (APBI) for the surgical bed of early-stage breast cancer patients with favorable histological subtypes, using stereotactic radiotherapy in a single dose of 15.5 Gy with Simultaneous Integrated Boost (SIB) to 21 Gy (study treatment, delivered in a single fraction) versus multifractionated radiotherapy of 30 Gy in 5 fractions (standard treatment, delivered in 5 fractions).
Eligibility Criteria
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
Contact & Investigator
Andrei Fodor, MD
PRINCIPAL INVESTIGATOR
IRCCS San Raffaele Scientific Institute
Frequently Asked Questions
Who can join the NCT06946238 clinical trial?
This trial is open to female participants only, aged 40 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06946238 currently recruiting?
Yes, NCT06946238 is actively recruiting participants. Contact the research team at fodor.andrei@hsr.it for enrollment information.
Where is the NCT06946238 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06946238 clinical trial?
NCT06946238 is sponsored by IRCCS San Raffaele. The principal investigator is Andrei Fodor, MD at IRCCS San Raffaele Scientific Institute. The trial plans to enroll 311 participants.
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