Single-session very accelerated partial breast radiation (sfVAPBI)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase II multicenter trial using single-fraction high-dose-rate multicatheter interstitial brachytherapy to deliver very accelerated partial breast irradiation after breast-conserving surgery. Eligible patients are generally women over 40 with unifocal early-stage (stage 0–II) tumors ≤3 cm, clear margins, and node-negative or micro‑metastatic status. The trial will measure clinical outcomes, late toxicity, and cosmetic results with follow-up to capture oncologic control and side effects. The protocol builds on prior VAPBI experience that reduced treatment to 2 days and on smaller single-fraction series suggesting a single session may be safe and effective.

Why it matters

Who can join: the full rules

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's running

• Antoine Lacassagne Cancer Centre
  Nice, France Recruiting
• University Hospital Erlangen
  Erlangen, Germany Recruiting
• National Institute of Oncology
  Budapest, Hungary Recruiting
• National Institute of Oncology
  Gliwice, Poland Recruiting
• Greater Poland Cancer Centre
  Poznan, Poland Recruiting
• Oncology Institute Vojvodina
  Kamenica, Serbia Recruiting

Study contacts

• Principal investigator: Viktor Smanykó, MD — National Institute of Oncology, Budapest, Hungary
• Study coordinator: Viktor Smanykó, MD
• Email: smanyko.viktor@oncol.hu
• Phone: +3612248600

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.