Single Fraction Preoperative Radiotherapy for Early Stage Breast Cancer
Recruiting · NCT04679454 · Interventional (participants receive a specific treatment) · Lead sponsor: European Institute of Oncology
View the official record on ClinicalTrials.gov →Interventions studied
Phase IPhase II
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- IEO, European Institute of Oncology IRCCS - Milan, Italy