Actively Recruiting
Ablative SBRT in Elderly BC Patients
Led by University Hospital, Geneva · Updated on 2026-05-11
36
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Stereotactic body radiotherapy (SBRT) is a modern radiotherapy technique, through which extremely high doses of irradiation are delivered in a very precise manner, within a few fractions. SBRT is increasingly used into clinical practice because it can provide excellent local control, comparable to surgery, in many tumor locations, such as lung, liver or bone. Efforts to develop it for BC treatment are promising, as it is safe, convenient, and effective. To date, SBRT for BC has been developed as an alternative method of partial-breast irradiation (PBI) in the pre- or post-operative setting. Therefore, the doses tested are comparable to the conventional doses used with surgery although its potential as sole local treatment for BC remains unknown. Higher SBRT doses are expected to permit obtaining an ablative effect on tumor and be suitable as an alternative to surgery, but this hypothesis has yet to be tested. The aim of the present study is to prove the feasibility of SBRT as an ablative treatment in early breast cancer (BC). The primary objective is to find the maximum tolerated dose of SBRT that can be safely administered in inoperable patients with BC, the majority of whom are elderly or oldest old. The overall objective is to determine whether high precision, dose- and fractionation- adapted SBRT is feasible and safe in inoperable patients with BC. The dose and fractionation-adapted SBRT regimen permits to test feasibility in different tumor sizes. The primary objective of this study is to establish the maximum tolerated dose (MTD) that can be delivered with a single or few (up to 5) fractions of SBRT in inoperable patients with BC.
CONDITIONS
Official Title
Ablative SBRT in Elderly BC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 70 years
- Histologically confirmed diagnosis of breast cancer before enrollment
- ECOG performance status between 0 and 3
- Patient considered inoperable or refuses surgery based on multidisciplinary board decision
- Presence of measurable breast tumor by imaging (ultrasound, CT, or MRI)
- Primary tumor accessible to SBRT as determined by radiation oncologist
- Neo-adjuvant systemic therapy allowed
- Tumor size suitable for SBRT delivery as assessed by planning CT
- Multifocal tumors allowed if total treatment volume suitable for SBRT
- Tumor treatment volume not exceeding 30% of whole breast volume
- Previous treatment to contralateral breast or non-breast conditions allowed
- Patient able to cooperate with SBRT delivery
- Patient able to understand and sign informed consent according to ICH/GCP regulations
You will not qualify if you...
- Prior surgery for the current breast cancer diagnosis
- Prior whole or partial breast irradiation to the involved breast
- Absolute contraindications to radiotherapy such as Li-Fraumeni syndrome
- Participation in another investigational study or use of investigational device within 4 weeks before treatment
- Inability to communicate meaningfully with study staff or lack of discernment
- Serious medical, psychiatric, psychological, familial, or geographic conditions that may interfere with study participation or increase treatment risks
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Trial Site Locations
Total: 1 location
1
Radiation Oncology Department, Geneva University Hospital
Geneva, Switzerland, 1205
Actively Recruiting
Research Team
P
Pelagia Tsoutsou, Pr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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