Clinical Trial

Single-fraction APBI for Early-stage Breast Cancer With Favorable Histological Subtypes (Breast-1F)

Study acronym: Breast-1F
Recruiting
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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).
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-04-19; most recent amendment 2025-11-26.
Status change: Not Yet Recruiting → Recruiting 2025-07-25
Trial Details
NCT Number NCT06946238
Lead Sponsor IRCCS San Raffaele
Conditions Breast Cancer
Enrollment 311 participants
Start Date 2025-07-25
Primary Completion 2029-06-30 (estimated)
Study Completion 2035-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-04