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Single-Fraction very accelerated partial breast irradiation (sfVAPBI) in Low-Risk invasive or ductal in situ breast carcinoma - phase II multicenter trial

NCT ID NCT07067437

NEW Sponsor: National Institute of Oncology, Hungary Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Aug 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    23 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Antoine Lacassagne Cancer Centre

    RECRUITING

    Nice, France

  • Centre Léon Bérard

    NOT_YET_RECRUITING

    Lyon, France

  • Fundacion IMOR's Oncology Clinic

    NOT_YET_RECRUITING

    Barcelona, Spain

  • Greater Poland Cancer Centre

    RECRUITING

    Poznan, Poland

  • Hospital Universitario de Navarra

    NOT_YET_RECRUITING

    Pamplona, Spain

  • Hospital del Mar

    RECRUITING

    Barcelona, 08003, Spain

  • Inselspital, Universitätsspital Bern

    NOT_YET_RECRUITING

    Bern, Switzerland

  • Institut Catala d'Oncologia

    RECRUITING

    Barcelona, Spain

  • Institut de Cancérologie de Lorraine

    NOT_YET_RECRUITING

    Nancy, France

  • Instituto Português de Oncologia do Porto

    NOT_YET_RECRUITING

    Porto, Portugal

  • Instituto Valenciano de Oncologia

    NOT_YET_RECRUITING

    Valencia, Spain

  • Klinikum Bremerhaven

    NOT_YET_RECRUITING

    Bremerhaven, Germany

  • Lower Silesian Oncology, Pulmonology and Hematology Center

    NOT_YET_RECRUITING

    Wroclaw, Poland

  • Maria Skłodowska-Curie Bialystok Oncology Center

    NOT_YET_RECRUITING

    Bialystok, Poland

  • National Cancer Institute

    NOT_YET_RECRUITING

    Vilnius, Lithuania

  • National Institute of Oncology

    RECRUITING

    Budapest, Hungary

  • National Institute of Oncology

    RECRUITING

    Gliwice, Poland

  • Oncology Institute Vojvodina

    RECRUITING

    Kamenica, Serbia

  • Sana Klinikum Offenbach

    NOT_YET_RECRUITING

    Offenbach, Germany

  • Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny

    NOT_YET_RECRUITING

    Brzozów, Poland

  • University Hospital Erlangen

    RECRUITING

    Erlangen, Germany

  • Universitätsklinikum Schleswig-Holstein

    NOT_YET_RECRUITING

    Lübeck, Germany

  • Universitätsklinikum Würzburg

    NOT_YET_RECRUITING

    Würzburg, Germany

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