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Breast NeoplasmssfVAPBINCT07067437

Single-Fraction Very Accelerated Partial Breast Irradiation (sfVAPBI)

A study testing single-fraction very accelerated partial breast irradiation in people with Breast Neoplasms, run by National Institute of Oncology, Hungary at 23 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 years and older, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
single-fraction very accelerated partial breast irradiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
23 sitesin 9 countries
Study dates
1 Jul 2025to 1 Aug 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

23 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Viktor Smanykó, MD contact

+3612248600 ext. 3440

smanyko.viktor@oncol.hu

23 sites in 9 countries

Germany5 sites, 5 recruiting

  • Klinikum Bremerhaven

    Bremerhaven

    Razvan Galalae, MD, Razvan.Galalae@klinikum-bremerhaven.de

    Razvan Galalae, MD

    Not yet recruiting

  • University Hospital Erlangen

    Erlangen

    Vratislav Strnad, MD, Vratislav.Strnad@uk-erlangen.de

    Vratislav Strnad, MD

    Recruiting

  • Universitätsklinikum Schleswig-Holstein

    Lübeck

    Tamer Soror, MD, tamer.soror@uksh.de

    Tamer Soror, MD

    Not yet recruiting

  • Sana Klinikum Offenbach

    Offenbach

    Peter Niehoff, MD, Peter.Niehoff@Sana.de

    Peter Niehoff, MD

    Not yet recruiting

  • Universitätsklinikum Würzburg

    Würzburg

    Büllent Polat, MD, polat_b@ukw.de

    Büllent Polat, MD

    Not yet recruiting

Other trials in Germany

Poland5 sites, 5 recruiting

  • Maria Skłodowska-Curie Bialystok Oncology Center

    Bialystok

    Dorota Kazberuk, MD, d.kazberuk@onet.pl

    Dorota Kazberuk, MD

    Not yet recruiting

  • Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny

    Brzozów

    Damian Kazalski, MD, damian.kazalski@gmail.com

    Damian Kazalski, MD

    Not yet recruiting

  • National Institute of Oncology

    Gliwice

    Magdalena Stankiewicz, MD, Magdalena.Stankiewicz@io.gliwice.pl

    Magdalena Stankiewicz, MD

    Recruiting

  • Greater Poland Cancer Centre

    Poznan

    Adam Chicel, MD, adam.chichel@wco.pl

    Adam Chicel, MD

    Recruiting

  • Lower Silesian Oncology, Pulmonology and Hematology Center

    Wroclaw

    Katarzyna Konat-Bąska, MD, Konatkasia@gmail.com

    Katarzyna Konat-Bąska, MD

    Not yet recruiting

Other trials in Poland

Spain5 sites, 5 recruiting

  • Hospital del Mar

    Barcelona, 08003

    Cristina Gutierrez-Miguelez, 93 248 30 00, cristina.gutierrez@hmar.cat

    Recruiting

  • Fundacion IMOR's Oncology Clinic

    Barcelona

    Benjamin Guix, MD, drguix@icloud.com

    Benjamin Guix, MD

    Not yet recruiting

  • Institut Catala d'Oncologia

    Barcelona

    Cristina Gutierrez-Miguelez, MD, cgutierrezm@iconcologia.net

    Cristina Gutierrez-Miguelez, MD

    Recruiting

  • Hospital Universitario de Navarra

    Pamplona

    Irene Martínez, MD, mm.irene10@gmail.com

    Irene Martínez, MD

    Not yet recruiting

  • Instituto Valenciano de Oncologia

    Valencia

    Jose-Luis Guinot, MD, jguinot@fivo.org

    Jose-Luis Guinot, MD

    Not yet recruiting

Other trials in Spain

France3 sites, 3 recruiting

  • Centre Léon Bérard

    Lyon

    Salvatore Cozzi, MD, salvatore.cozzi@lyon.unicancer.fr

    Salvatore Cozzi, MD

    Not yet recruiting

  • Institut de Cancérologie de Lorraine

    Nancy

    Marie Bruand, MD, m.bruand@nancy.unicancer.fr

    Marie Bruand, MD

    Not yet recruiting

  • Antoine Lacassagne Cancer Centre

    Nice

    Jean-Michel Hannoun-Levi, MD, jean-michel.hannoun-levi@nice.unicancer.fr

    Jean-Michel Hannoun-Levi, MD

    Recruiting

Other trials in France

Hungary1 site, 1 recruiting

  • National Institute of Oncology

    Budapest

    Smanykó Viktor, MD, +3612248600, smanyko.viktor@oncol.hu

    Viktor Smanykó, MD

    Recruiting

Other trials in Hungary

Lithuania1 site, 1 recruiting

  • National Cancer Institute

    Vilnius

    Justinas Jonusas, MD, justinas.jonusas@nvi.lt

    Justinas Jonusas, MD

    Not yet recruiting

Other trials in Lithuania

Portugal1 site, 1 recruiting

  • Instituto Português de Oncologia do Porto

    Porto

    Pedro B Fenandes, MD, pedro.fernandes@ipoporto.min-saude.pt

    Pedro B Fenandes, MD

    Not yet recruiting

Other trials in Portugal

Serbia1 site, 1 recruiting

  • Oncology Institute Vojvodina

    Kamenica

    Olivera Ivanov, MD, olivera.ivanov@yahoo.com

    Olivera Ivanov, MD

    Recruiting

Other trials in Serbia

Switzerland1 site, 1 recruiting

  • Inselspital, Universitätsspital Bern

    Bern

    Kristina Lössl, MD, kristina.loessl@insel.ch

    Kristina Lössl, MD

    Not yet recruiting

Other trials in Switzerland

About this study

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

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.

Read the detailed description

Accelerated Partial Breast Irradiation (APBI) has demonstrated the non-inferiority compared to external beam radiotherapy (EBRT) in the conserving-treatment of early breast carcinoma by using high-dose-rate (HDR) multicatheter interstitial brachytherapy (MIBT). The standard treatment regimen is 7-8 sessions with two treatments per day, for a total treatment time of 4-5 days. Based on 5-year results of the Groupe Européen de Curiethérapie European SocieTy for Radiotherapy \& Oncology (GEC-ESTRO) Very Accelerated Partial Breast Irradiation (VAPBI) phase I-II trial, in low-risk cases, 3-4 fractions delivered in 2 days reduced the overall treatment time with low rate of side effects and excellent oncological outcome.

Retrospective and prospective studies with a single fraction HDR MIBT-based VAPBI suggest that by further increasing the dose delivered in one fraction, the total treatment time can be reduced to a single session safely.

A phase II multicenter trial is proposed to confirm this hypothesis.

Being tested
single-fraction very accelerated partial breast irradiation
Keywords
breast cancer, brachytherapy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • single-fraction very accelerated partial breast irradiationRadiation

    Adjuvant accelerated partial breast brachytherapy, with interstitial multicatheter technique, in one fraction.

Study groups in NCT07067437
Study groupRoleWhat they receive
single-fraction very accelerated partial breast irradiation armExperimentalLow risk, early-stage breast cancer patients, who receiving single-fraction very accelerated partial breast irradiation, as postoperative radiation therapy.
Receives: Radiation: single-fraction very accelerated partial breast irradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Five-year incidence of late grade ≥ 2 side effects

    Radiation side effects based on Common Terminology Criteria for Adverse Events (CTCAE) (grade 1 to grade 5, higher score worse); and with the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/EORTC) Late Radiation Morbidity Scoring Schema (grade 1 to grade 4, higher score worse).

    Measured: From the third month of treatment to the end of the fifth year of follow-up.

Secondary outcomes (10)

  1. Incidence (5-year actuarial rate) of ipsilateral breast recurrence (IBR)

    Measured: From treatment to the end of the fifth year of follow-up.

  2. Incidence (5-year actuarial rate) of regional relapse (RR)

    Measured: From treatment to the end of the fifth year of follow-up.

  3. Incidence (5-year actuarial rate) of contralateral breast cancer (CBC)

    Measured: From treatment to the end of the fifth year of follow-up.

  4. Incidence (5-year actuarial rate) of distant metastasis (DM)

    Measured: From treatment to the end of the fifth year of follow-up.

  5. Incidence (5-year actuarial rate) of any relapse (local, regional or distant, whichever came first) for disease free survival (DFS)

    Measured: From treatment to the end of the fifth year of follow-up.

  6. Incidence (5-year actuarial rate) of breast cancer death for cause specific survival (CSS)

    Measured: From treatment to the end of the fifth year of follow-up.

  7. Incidence (5-year actuarial rate) of death by any cause for overall survival (OS)

    Measured: From treatment to the end of the fifth year of follow-up.

  8. Incidence of acute side effects

    Radiation side effects based on Common Terminology Criteria for Adverse Events (CTCAE) (grade 1 to grade 5, higher score worse); and with the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/EORTC) Late Radiation Morbidity Scoring Schema (grade 1 to grade 4, higher score worse).

    Measured: From treatment to the end of the first 3 months of follow-up.

  9. Cosmetic results at 5 years

    Cosmetic results based on the Harvard criteria (excellent, good, fair, poor).

    Measured: From treatment to the end of the fifth year of follow-up.

  10. Quality of Life (QoL)

    European Organisation For Research And Treatment Of Cancer (EORTC) Quality of Life questionnaire (QLQ) C30 questionaire including the Breast cancer module (QLQ-BR23) (53 questions in total, from 1 to 4 points, higher score worse)

    Measured: From treatment to the end of the fifth year of follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2025
  2. Study start1 Jul 2025
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Aug 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07067437
Sponsor's protocol ID
GEC-ESTRO sfVAPBI
Other IDs
1012
Acronym
sfVAPBI
Status last verified
Sep 2026
First submitted
25 Jun 2025
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 3-letter abbreviation of the city of the treating hospital. Identification number of the treated patient. Performance score. Detailed histological characteristics of the breast cancer. Data of surgery and brachytherapy. Dosimetrical data. Cosmesis. Side effects. Oncological outcomes.

Publications

  • Hannoun-Levi JM, Montagne L, Sumodhee S, Schiappa R, Boulahssass R, Gautier M, Gal J, Chand ME. APBI Versus Ultra-APBI in the Elderly With Low-Risk Breast Cancer: A Comparative Analysis of Oncological Outcome and Late Toxicity. Int J Radiat Oncol Biol Phys. 2021 Sep 1;111(1):56-67. doi: 10.1016/j.ijrobp.2021.03.052. Epub 2021 Apr 6.

    PubMed 33831490

  • Hannoun-Levi JM, Gimeno Morales M, Gal J, Anchuelo J, Guinot JL, Gaztanaga M, Meszaros N, Polgar C, Strnad V, Schiappa R, Gutierrez C. Very accelerated partial breast irradiation in 1 or 2 days: Late toxicity and early oncological outcome of the GEC-ESTRO VAPBI cohort. Radiother Oncol. 2024 May;194:110217. doi: 10.1016/j.radonc.2024.110217. Epub 2024 Mar 8.

    PubMed 38460552

  • Hannoun-Levi JM, Lam Cham Kee D, Gal J, Schiappa R, Hannoun A, Fouche Y, Gautier M, Boulahssass R, Chand ME. Accelerated partial breast irradiation in the elderly: 5-Year results of the single fraction elderly breast irradiation (SiFEBI) phase I/II trial. Brachytherapy. 2020 Jan-Feb;19(1):90-96. doi: 10.1016/j.brachy.2019.10.007. Epub 2019 Nov 23.

    PubMed 31767533

  • Guinot JL, Gutierrez-Miguelez C, Meszaros N, Gonzalez-Perez V, Santos MA, Najjari D, Slocker A, Major T, Polgar C. Five-year results of the very accelerated partial breast irradiation VAPBI phase I-II GEC-ESTRO trial. Radiother Oncol. 2024 Dec;201:110543. doi: 10.1016/j.radonc.2024.110543. Epub 2024 Sep 24.

    PubMed 39321957

  • Strnad V, Polgar C, Ott OJ, Hildebrandt G, Kauer-Dorner D, Knauerhase H, Major T, Lyczek J, Guinot JL, Gutierrez Miguelez C, Slampa P, Allgauer M, Lossl K, Polat B, Fietkau R, Schlamann A, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Dunst J, Gall C, Uter W; Groupe Europeen de Curietherapie and European Society for Radiotherapy and Oncology. Accelerated partial breast irradiation using sole interstitial multicatheter brachytherapy compared with whole-breast irradiation with boost for early breast cancer: 10-year results of a GEC-ESTRO randomised, phase 3, non-inferiority trial. Lancet Oncol. 2023 Mar;24(3):262-272. doi: 10.1016/S1470-2045(23)00018-9. Epub 2023 Feb 1.

    PubMed 36738756

Questions about this trial

What is this clinical trial studying?

A study testing single-fraction very accelerated partial breast irradiation in people with Breast Neoplasms, run by National Institute of Oncology, Hungary at 23 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Germany, Poland, Spain, France, Hungary and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Viktor Smanykó, MD (+3612248600 ext. 3440, smanyko.viktor@oncol.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Five-year incidence of late grade ≥ 2 side effects (time frame: From the third month of treatment to the end of the fifth year of follow-up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07067437, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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