Preoperative radiotherapy for early stage breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the feasibility, safety, and efficacy of a single fraction of preoperative ablative radiotherapy for patients with early-stage breast cancer. It consists of two main sections: a technical study focusing on the setup and dosimetric aspects of the CyberKnife system, and a clinical study that includes a phase I dose escalation to determine the maximum tolerated dose and a phase II study to assess the rate of pathological complete response. Patients will undergo surgical tumor removal 4-8 weeks after the radioablation treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically proven unifocal adenocarcinoma
* T1-T2
* Tumor size up to 2.5 cm
* cN0
* Age ≥ 18 years old
* Good general condition (ECOG 0-2)
* Planned BCS
* Written informed consent

Exclusion Criteria:

* Tumor close to skin or chest wall
* Pure non-invasive tumor
* Prior RT to the chest
* Neoadjuvant chemotherapy
* Collagenopathies
* Coagulation or autoimmunitary disorders
* Previous malignancies

Where it's running

• IEO, European Institute of Oncology IRCCS
  Milan, Italy Recruiting

Study contacts

• Principal investigator: Maria Cristina Leonardi — European Institute of Oncology
• Study coordinator: Maria Cristina Leonardi, MD
• Email: cristina.leonardi@ieo.it
• Phone: +39 02 57489037

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.