Single Fraction Preoperative Radiotherapy for Early Stage Breast Cancer

Recruiting now · Not applicable

Conditions studied: Breast Cancer

In brief

This is a phase I/II, single-arm and open-label single-centre clinical trial with the aim to test the feasibility, safety and the efficacy, in terms of complete pathological response, of preoperative ablative radiotherapy in single fraction for selected breast cancer patients.

Key facts

Study ID

NCT04679454

Run by

European Institute of Oncology

People needed

79

Starts

2021-07-31

Expected to finish

2029-03-01

Last updated by the study team

2024-08-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• IEO, European Institute of Oncology IRCCS — Milan, Italy (enrolling)

Full record on ClinicalTrials.gov

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