NCT04679454 Single Fraction Preoperative Radiotherapy for Early Stage Breast Cancer
| NCT ID | NCT04679454 |
| Status | Recruiting |
| Phase | — |
| Sponsor | European Institute of Oncology |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 79 participants |
| Start Date | 2021-07-31 |
| Primary Completion | 2026-03 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
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
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