NCT06946238

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 311 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The project refers to a study on patients with early-stage breast cancer with pathological Tumor stage (pT) from in situ (pTis) to pT2 up to 3 cm in diameter, and pathological/clinical nodal stage p/cN0, and favorable histology (Luminal A and Luminal B human epidermal growth factor receptor 2 (HER2)-negative subtypes), comparing an APBI treatment delivered with stereotactic radiotherapy to the Planning Target Volume (PTV) of the tumor bed of the breast with a total dose (TD) of 15.5 Gy in one fraction, with simultaneous integrated boost (SIB) to a TD of 21 Gy to the Gross Tumor Volume (GTV) represented by tumor bed, versus 30 Gy in 5 consecutive fractions to the PTV of the tumor bed, according to the standard APBI protocol of the department (Florence protocol).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-25
• Primary completion: 2029-06-30
• Completion: 2035-06-30
• First posted: 2025-04-27
• Last updated: 2025-12-04

Locations

1 site across 1 country: Italy