Status:
RECRUITING
Single Fraction Preoperative Radiotherapy for Early Stage Breast Cancer
Lead Sponsor:
European Institute of Oncology
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ...
Detailed Description
The research plan is conceived in two sections, as follows. (i)The technical study handles the set-up, motion and dosimetric issues of the radioablation technique using CyberKnife system. (ii)The cli...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT04679454
Start Date
July 31 2021
End Date
March 1 2029
Last Update
August 5 2024
Active Locations (1)
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1
IEO, European Institute of Oncology IRCCS
Milan, Italy, 20141