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Single-Fraction Very Accelerated Partial Breast Irradiation (sfVAPBI)

RecruitingNAAges 40 Years - anyFemaleNational Institute of Oncology, Hungary
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • single-fraction very accelerated partial breast irradiation
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Where

23 sites
Centre Léon Bérard
Lyon, France
Institut de Cancérologie de Lorraine
Nancy, France
Antoine Lacassagne Cancer Centre
Nice, France
Klinikum Bremerhaven
Bremerhaven, Germany
University Hospital Erlangen
Erlangen, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Germany
Sana Klinikum Offenbach
Offenbach, Germany
Universitätsklinikum Würzburg
Würzburg, Germany

…and 15 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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