Single-session very accelerated partial breast radiation (sfVAPBI)

Single-Fraction Very Accelerated Partial Breast Irradiation (sfVAPBI) in Low-Risk Invasive or Ductal In Situ Breast Carcinoma - Phase II Multicenter Trial

This trial will test whether one high-dose, catheter-based radiation session after surgery can control early-stage breast cancer with acceptable side effects and cosmetic results.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 40 Years and up
• Sex: Female
• Sponsor: National Institute of Oncology, Hungary (other)
• Drugs / interventions: chemotherapy
• Locations: 22 sites (Lyon and 21 other locations)
• Trial ID: NCT07067437 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients older than 40 with unifocal early-stage breast cancer ≤3 cm, clear surgical margins, node-negative or pN1mi status, luminal A/B biology, and who can start radiotherapy within the protocol time windows.

Not a fit: Patients with larger tumors (>3 cm), multicentric disease beyond 2 cm, positive margins, stage III–IV disease, significant nodal involvement beyond pN1mi, or younger than 40 are unlikely to benefit from this single-fraction approach.

Why it matters

Potential benefit: If successful, this approach could replace multiple radiation visits with a single treatment session while preserving cancer control and cosmetic outcomes.

How similar studies have performed: Prior GEC-ESTRO VAPBI phase I–II work and small retrospective/prospective single-fraction series reported promising oncologic and cosmetic outcomes, but single-fraction treatment has not yet been confirmed in large multicenter trials.

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

Where this trial is running

Lyon and 21 other locations

• Centre Léon Bérard — Lyon, France (NOT_YET_RECRUITING)
• Institut de Cancérologie de Lorraine — Nancy, France (NOT_YET_RECRUITING)
• Antoine Lacassagne Cancer Centre — Nice, France (NOT_YET_RECRUITING)
• Klinikum Bremerhaven — Bremerhaven, Germany (NOT_YET_RECRUITING)
• University Hospital Erlangen — Erlangen, Germany (NOT_YET_RECRUITING)
• Universitätsklinikum Schleswig-Holstein — Lübeck, Germany (NOT_YET_RECRUITING)
• Sana Klinikum Offenbach — Offenbach, Germany (NOT_YET_RECRUITING)
• Universitätsklinikum Würzburg — Würzburg, Germany (NOT_YET_RECRUITING)
• National Institute of Oncology — Budapest, Hungary (RECRUITING)
• National Cancer Institute — Vilnius, Lithuania (NOT_YET_RECRUITING)
• Maria Skłodowska-Curie Bialystok Oncology Center — Bialystok, Poland (NOT_YET_RECRUITING)
• Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny — Brzozów, Poland (NOT_YET_RECRUITING)
• National Institute of Oncology — Gliwice, Poland (NOT_YET_RECRUITING)
• Greater Poland Cancer Centre — Poznan, Poland (NOT_YET_RECRUITING)
• Lower Silesian Oncology, Pulmonology and Hematology Center — Wroclaw, Poland (NOT_YET_RECRUITING)
• Instituto Português de Oncologia do Porto — Porto, Portugal (NOT_YET_RECRUITING)
• Oncology Institute Vojvodina — Kamenica, Serbia (NOT_YET_RECRUITING)
• Fundacion IMOR's Oncology Clinic — Barcelona, Spain (NOT_YET_RECRUITING)
• Institut Catala d'Oncologia — Barcelona, Spain (NOT_YET_RECRUITING)
• Hospital Universitario de Navarra — Pamplona, Spain (NOT_YET_RECRUITING)
• Instituto Valenciano de Oncologia — Valencia, Spain (NOT_YET_RECRUITING)
• Inselspital, Universitätsspital Bern — Bern, Switzerland (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Viktor Smanykó, MD — National Institute of Oncology, Budapest, Hungary
• Study coordinator: Viktor Smanykó, MD

Conditions: Breast Neoplasms, breast cancer, brachytherapy