Radiotherapy in Preoperative Setting With CyberKnife for Breast Cancer

  • End date
    May 1, 2024
  • participants needed
  • sponsor
    Azienda Ospedaliero-Universitaria Careggi
Updated on 23 January 2021


The aim of this study is to prospectively evaluate, in patients affected by early breast cancer, safety and feasibility of single fraction radiotherapy with Cyberknife R in preoperative setting, and to identify factors predictive for outcome based on biologic and clinical parameters.


Monocentric, open-label, single-arm phase II study evaluating safety and efficacy of neoadjuvant radiotherapy in early breast cancer patients. Patients eligible are women aged 50 or more years old, affected by histologically proven invasive breast cancer, with positive hormonal receptors, grading 1 or 2, HER-2 negative, without lymphovascular invasion, and tumour size up to 2 cm (measured on mammography, ultrasound or magnetic resonance), negative clinical nodal status, eligible for BCS.

Condition Early Breast Cancer
Treatment Neoadjuvant radiotherapy
Clinical Study IdentifierNCT03520894
SponsorAzienda Ospedaliero-Universitaria Careggi
Last Modified on23 January 2021


Yes No Not Sure

Inclusion Criteria

Signed informed consent
Women 50 years old
Histological diagnosis of invasive breast cancer
ER positive ( 10% of tumoral cells present ER) and/or PR positive ( 10% of tumoral cells present PR)
Grading 1 or 2
Her2 negative (IHC 0-1+; in patients with IHC 2+, absence of amplification at FISH
No lymphovascular invasion evidence at biopsy
Early breast cancer (T1 N0 M0) clinically and radiologically defined (ultrasound study/ magnetic resonance)
Patients eligible for BCS

Exclusion Criteria

Extension of breast disease within 5 mm from the skin surface 2. Tumor size
> 2 cm 3. Patients affected by collagenopathies 4. Patients with BRCA1/2
mutations 5. Previous irradiation to homolateral breast 6. Previous
irradiation to homolateral thoracic wall 7. DCIS and/or Paget's disease 8
Psychiatric disorders preventing informed consent signature
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