Recruiting
Single Fraction Preoperative Radiotherapy for Early Stage Breast Cancer
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.
ClinicalTrials.gov IDNCT04679454
PhaseNA
Enrollment79
SponsorEuropean Institute of Oncology
Age18 Years
SexFEMALE
Conditions studied
Breast Cancer
About this study
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.
Interventions
- Radiation: Phase I — To establish the recommended dose defined as the maximum tolerated dose (MTD)The dose-limiting toxicity (DLT) is defined as any G3-G4 event according to NCI CTCAE Version 4.03 scale. Dose escalation is designed as a 3+3 rule-based study. Dose escalation will be initiated from a baseline dose of 18 Gy and increased to reach 21 Gy and 24 Gy. The population size includes 18 patients.
- Radiation: Phase II — The recommended dose from the phase I study is delivered, using Cyberknife in order to evaluate the efficacy measured in terms of pCR rate. The population size includes 61 patients.
Primary outcomes
- Phase I: Identify the maximum tolerated dose (MTD) (time frame:2 weeks)
- Phase II: Evaluate efficacy measured in terms of pCR rate (time frame:8 weeks)
Eligibility information
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
Study locations
- IEO, European Institute of Oncology IRCCS, Milan, 20141 Italy
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.