Skip to content
GeoClinicalTrials
Back to search

NCT07067437Recruiting

Single-Fraction Very Accelerated Partial Breast Irradiation (sfVAPBI)

Official recordSimplified version

Summary

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.

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

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
No phase (N/A)
Study type
Interventional
Countries
Switzerland, France, Germany, Hungary, Lithuania, Poland, Portugal, Serbia, Spain
Sponsor
National Institute of Oncology, Hungary(Other)
Protocol no.
GEC-ESTRO sfVAPBI
Conditions
Breast Neoplasms
Interventions
Radiation

Treatments studied

  • single-fraction very accelerated partial breast irradiation

Locations · 8

  • Nice, FranceAntoine Lacassagne Cancer CentreRecruiting at this site
  • Erlangen, GermanyUniversity Hospital ErlangenRecruiting at this site
  • Budapest, HungaryNational Institute of OncologyRecruiting at this site
  • Gliwice, PolandNational Institute of OncologyRecruiting at this site
  • Poznan, PolandGreater Poland Cancer CentreRecruiting at this site
  • Kamenica, SerbiaOncology Institute VojvodinaRecruiting at this site
  • Barcelona, SpainHospital del MarRecruiting at this site
  • Barcelona, SpainInstitut Catala d'OncologiaRecruiting at this site

In total, worldwide, 8 of the 23 sites listed in the registry are recruiting; the other 15 are not currently recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: September 9, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

Other identifiers

  • 1012 · other registry

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.