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

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).

Trial Details

NCT ID

NCT06946238

Phase

NA

Sponsor

IRCCS San Raffaele

Status

RECRUITING

Cancer Type

HER2 Negative Breast Cancer

Interventions

• Adjuvant single-fraction accelerated partial breast irradiation

Locations (sample)

• Milan, Italy|45.46427,9.18951

Key Eligibility Criteria

• Histological diagnosis of breast cancer
• Patients aged ≥40 years
• Signed informed consent
• Stage pTis-T2, up to 3 cm in the greatest diameter

For full eligibility, visit ClinicalTrials.gov.

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