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RECRUITING
NCT06946238
NA

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

Sponsor: IRCCS San Raffaele

View on ClinicalTrials.gov

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).

Official title: Accelerated Partial Breast Irradiation in One Fraction for Patients With Early-stage Disease and Favorable Histological Subtypes (Breast-1F).

Key Details

Gender

FEMALE

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

311

Start Date

2025-07-25

Completion Date

2035-06-30

Last Updated

2025-12-04

Healthy Volunteers

No

Conditions

Interventions

RADIATION

Adjuvant single-fraction accelerated partial breast irradiation

Experimental arm (arm 1-single-fraction APBI) patients will be treated to a total dose (TD) of 15.5 Gy to the PTV with a simultaneous integrated boost (SIB) to a TD of 21 Gy to the tumor bed, while arm 2-five-fractions APBI patients with 30 Gy/ 5 fractions to PTV.

Locations (1)

IRCCS San Raffaele Scientific Institute

Milan, Italy