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Single-Fraction Very Accelerated Partial Breast Irradiation (sfVAPBI)

RecruitingNA

Sponsor: National Institute of Oncology, Hungary

Conditions: Breast Neoplasms

Interventions: single-fraction very accelerated partial breast irradiation

Countries: France, Germany, Hungary, Lithuania, Poland, Portugal, Serbia, Spain

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.

Eligibility overview

Sex: FEMALE

Age: 40 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (23)

Lyon, France
Nancy, France
Nice, France
Bremerhaven, Germany
Erlangen, Germany
Lübeck, Germany
Offenbach, Germany
Würzburg, Germany
Budapest, Hungary
Vilnius, Lithuania
Bialystok, Poland
Brzozów, Poland
Gliwice, Poland
Poznan, Poland
Wroclaw, Poland
Porto, Portugal
Kamenica, Serbia
Barcelona, Spain
Barcelona, Spain
Barcelona, Spain
Pamplona, Spain
Valencia, Spain
Bern, Switzerland