Single-Fraction Very Accelerated Partial Breast Irradiation (sfVAPBI)
Recruiting · NCT07067437 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
single-fraction very accelerated partial breast irradiation
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.
Who can take part
Age range
40 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Stage 0 \& I \& II (\< 3 cm) breast carcinoma
- Lesions of \< 3 cm diameter
- Invasive carcinoma of any subtype and grade or ductal carcinoma in situ (DCIS)
- Nodal status: node-negative (pN0) or micro-metastatic (pN1mi) (patients with pN1mi status can be treated, but due to the limited clinical evidence, individual decision is needed)
- M0: Absence of distant metastasis
- Clear resection margins by National Surgical Adjuvant Breast and Bowel Project (NSABP) definition (no tumor on ink)
- Unifocal (multifocality limited within 2 cm) and unicentric breast cancer
- Age\> 40 years
- Luminal A or B tumors
- Time interval from surgery preferably less than 12 weeks and no longer than 20 weeks, and from adjuvant chemotherapy less than 4 weeks
- Human Epidermal growth factor Receptor 2 positive (HER2+) patients receiving postoperative anti-HER2 systemic therapy
- Specific signed consent form prior to randomization
Exclusion criteria
- Stage III-IV breast cancer
- Surgical margins that cannot be microscopically assessed
- Extensive intraductal component (EIC+)
- Extensive lymphovascular invasion (LVI+) (focal is allowed)
- Triple negative breast cancer
- BReast CAncer gene (BRCA) 1-2 mutation
- Human Epidermal growth factor Receptor 2 positive (HER2+) 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
Where it is running
23 locations listed.
- Hospital del Mar - Barcelona, Spain
- Fundacion IMOR's Oncology Clinic - Barcelona, Spain
- Institut Catala d'Oncologia - Barcelona, Spain
- Inselspital, Universitätsspital Bern - Bern, Switzerland
- Maria Skłodowska-Curie Bialystok Oncology Center - Bialystok, Poland
- Klinikum Bremerhaven - Bremerhaven, Germany
- Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny - Brzozów, Poland
- National Institute of Oncology - Budapest, Hungary
- University Hospital Erlangen - Erlangen, Germany
- National Institute of Oncology - Gliwice, Poland
- Oncology Institute Vojvodina - Kamenica, Serbia
- Centre Léon Bérard - Lyon, France
- Universitätsklinikum Schleswig-Holstein - Lübeck, Germany
- Institut de Cancérologie de Lorraine - Nancy, France
- Antoine Lacassagne Cancer Centre - Nice, France
- Sana Klinikum Offenbach - Offenbach, Germany
- Hospital Universitario de Navarra - Pamplona, Spain
- Instituto Português de Oncologia do Porto - Porto, Portugal
- Greater Poland Cancer Centre - Poznan, Poland
- Instituto Valenciano de Oncologia - Valencia, Spain
- National Cancer Institute - Vilnius, Lithuania
- Lower Silesian Oncology, Pulmonology and Hematology Center - Wroclaw, Poland
- Universitätsklinikum Würzburg - Würzburg, Germany