Actively Recruiting
Single-Fraction Very Accelerated Partial Breast Irradiation (sfVAPBI)
Led by National Institute of Oncology, Hungary · Updated on 2025-07-16
250
Participants Needed
22
Research Sites
369 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To investigate clinical outcomes, late side effects, and cosmetic results of a single-fraction very accelerated partial breast irradiation as postoperative local treatment for the treatment of early stage breast cancer.
CONDITIONS
Official Title
Single-Fraction Very Accelerated Partial Breast Irradiation (sfVAPBI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Stage 0, I, or II breast carcinoma with tumor size less than 3 cm
- Invasive carcinoma of any subtype and grade or ductal carcinoma in situ (DCIS)
- Node-negative (pN0) or micrometastatic (pN1mi) nodal status
- No distant metastasis (M0)
- Clear surgical resection margins with no tumor on ink
- Unifocal and unicentric breast cancer (multifocality limited within 2 cm)
- Age over 40 years
- Luminal A or B tumor types
- Surgery performed preferably less than 12 weeks and no longer than 20 weeks before treatment
- Less than 4 weeks since adjuvant chemotherapy if given
- HER2 positive patients receiving postoperative anti-HER2 systemic therapy
- Signed informed consent prior to randomization
You will not qualify if you...
- Stage III or IV breast cancer
- Surgical margins that cannot be microscopically assessed
- Extensive intraductal component (EIC+)
- Extensive lymphovascular invasion (LVI+), though focal LVI is allowed
- Triple negative breast cancer
- BRCA 1 or 2 mutation
- HER2 positive patients not receiving postoperative anti-HER2 systemic therapy
- Neoadjuvant systemic therapy
- Paget's disease or pathological skin involvement
- Synchronous or previous breast cancer
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
Centre Léon Bérard
Lyon, France
Not Yet Recruiting
2
Institut de Cancérologie de Lorraine
Nancy, France
Not Yet Recruiting
3
Antoine Lacassagne Cancer Centre
Nice, France
Not Yet Recruiting
4
Klinikum Bremerhaven
Bremerhaven, Germany
Not Yet Recruiting
5
University Hospital Erlangen
Erlangen, Germany
Not Yet Recruiting
6
Universitätsklinikum Schleswig-Holstein
Lübeck, Germany
Not Yet Recruiting
7
Sana Klinikum Offenbach
Offenbach, Germany
Not Yet Recruiting
8
Universitätsklinikum Würzburg
Würzburg, Germany
Not Yet Recruiting
9
National Institute of Oncology
Budapest, Hungary
Actively Recruiting
10
National Cancer Institute
Vilnius, Lithuania
Not Yet Recruiting
11
Maria Skłodowska-Curie Bialystok Oncology Center
Bialystok, Poland
Not Yet Recruiting
12
Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny
Brzozów, Poland
Not Yet Recruiting
13
National Institute of Oncology
Gliwice, Poland
Not Yet Recruiting
14
Greater Poland Cancer Centre
Poznan, Poland
Not Yet Recruiting
15
Lower Silesian Oncology, Pulmonology and Hematology Center
Wroclaw, Poland
Not Yet Recruiting
16
Instituto Português de Oncologia do Porto
Porto, Portugal
Not Yet Recruiting
17
Oncology Institute Vojvodina
Kamenica, Serbia
Not Yet Recruiting
18
Fundacion IMOR's Oncology Clinic
Barcelona, Spain
Not Yet Recruiting
19
Institut Catala d'Oncologia
Barcelona, Spain
Not Yet Recruiting
20
Hospital Universitario de Navarra
Pamplona, Spain
Not Yet Recruiting
21
Instituto Valenciano de Oncologia
Valencia, Spain
Not Yet Recruiting
22
Inselspital, Universitätsspital Bern
Bern, Switzerland
Not Yet Recruiting
Research Team
V
Viktor Smanykó, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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