Breast Neoplasms / single-fraction very accelerated partial breast irradiation · Interventional Study

Single-Fraction Very Accelerated Partial Breast Irradiation (sfVAPBI)

ClinicalTrials.gov · September 9, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record for an ongoing interventional trial investigating single-fraction very accelerated partial breast irradiation as postoperative treatment for early-stage breast cancer. No results have been posted to the registry; the study is currently recruiting.

What was studied

Interventional, Single Group, Open label, Treatment purpose. Breast Neoplasms; Female; age from 40 Years. Intervention: single-fraction very accelerated partial breast irradiation…. n = 250. 23 sites across 9 countries.

Key findings

Safety

This is a registry record with no results posted; outcomes, effect sizes, and safety data are not yet available. No interim or preliminary efficacy or safety data are reported.

Who this may help

No clinical impact can be assessed until results are reported. This record documents a planned study of a novel single-fraction approach; clinicians should await outcome publication before considering adoption.

Plain-language summary

This is an active registry record for an interventional study with no reported results; it describes a planned investigation of a novel single-fraction radiation approach in early breast cancer.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Five-year incidence of late grade ≥ 2 side effects (assessed at From the third month of treatment to the end of the fifth year of follow-up.)

DesignInterventional, Single Group, Open label, Treatment purpose

PopulationBreast Neoplasms; Female; age from 40 Years

Sample size250

Interventionsingle-fraction very accelerated partial breast irradiation…

Setting23 sites across 9 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment250

Primary outcome measureFive-year incidence of late grade ≥ 2 side effects

Follow-up durationFrom third month of treatment to end of fifth year

Clinical bottom line

Caveats

This is a registry record with no results posted; outcomes, effect sizes, and safety data are not yet available.
Study design details (randomisation, blinding, comparator arm) are not fully described in the registry text.
No interim or preliminary efficacy or safety data are reported.
Study is currently recruiting; completion and results timeline unknown.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

insufficient

Registry record only; no control arm or comparator specified in text.

Directness

moderate

Primary outcome is late toxicity and cosmesis in early-stage breast cancer; clinically relevant.

Consistency

insufficient

No results reported; consistency cannot be assessed.

Risk of bias

insufficient

Study protocol not detailed; blinding, randomisation method not stated in registry text.

Sample adequacy

moderate

Planned enrollment of 250 participants with five-year follow-up for late toxicity.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07067437). This is a study registration, not published results. Lead sponsor: National Institute of Oncology, Hungary. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 250 participants (ESTIMATED). Conditions: Breast Neoplasms. Interventions: RADIATION: single-fraction very accelerated partial breast irradiation. Primary outcome measures: Five-year incidence of late grade ≥ 2 side effects , From the third month of treatment to the end of the fifth year of follow-up.. Brief 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

National Institute of Oncology, HungaryNCT07067437Breast Neoplasmssingle-fraction very accelerated partial breast irradiation