Actively Recruiting

Phase Not Applicable
Age: 40Years +
FEMALE
NCT06946238

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

Led by IRCCS San Raffaele · Updated on 2025-12-04

311

Participants Needed

1

Research Sites

518 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histological diagnosis of breast cancer
  • Patients aged 240 years
  • Signed informed consent
  • Stage pTis-T2, up to 3 cm in the greatest diameter
  • Luminal A and Luminal B HER2-negative histological subtypes
  • Negative surgical margins (20.2 cm)
  • Negative lymph nodes at sentinel lymph node biopsy or by imaging tests (PET/CT, axillary ultrasound, breast MRI), or by axillary dissection if done
  • Clinical M0 confirmed by imaging (PET/CT, bone scintigraphy, abdomen-pelvis CT) within the previous 3 months
  • Performance Status ECOG 2
  • No prior thoracic radiotherapy
  • Fertile women using contraception during oncological treatment
Not Eligible

You will not qualify if you...

  • Patients younger than 40 years
  • Tumors larger than 3 cm
  • Multicentric tumors
  • Positive or close surgical margins (<0.2 cm)
  • Lobular carcinoma
  • Negative hormone receptors
  • HER2-positive status
  • BRCA1 and/or BRCA2 gene positive if known
  • Severe systemic diseases
  • Psychiatric or other disorders preventing informed consent
  • Previous invasive cancer except certain skin cancers unless disease-free for at least 3 years
  • Collagen or autoimmune diseases such as lupus, rheumatoid arthritis, scleroderma, Sjogren's syndrome
  • Lymph node disease (N1)
  • Evidence of distant metastasis (M1)
  • Contraindication to systemic treatment
  • Pregnant women
  • Non-compliance with dose limits in treatment plan

AI-Screening

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Trial Site Locations

Total: 1 location

1

IRCCS San Raffaele Scientific Institute

Milan, Italy, 20132

Actively Recruiting

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Research Team

A

Andrei Fodor, MD

CONTACT

N

Nadia G Di Muzio, Prof

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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