Single-Fraction Very Accelerated Partial Breast Irradiation (sfVAPBI)

NCT07067437 | Recruiting

• 2 other identifiers: GEC-ESTRO sfVAPBI1012
• Study Type: interventional
• Target: 250
• Locations: 9 countries
• Sites: 22

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.

Conditions

Breast Neoplasms

Keywords

breast cancer; brachytherapy

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (10)

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

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

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

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

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

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

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

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

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

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

Study Arms (1)

single-fraction very accelerated partial breast irradiation arm

EXPERIMENTAL

Low risk, early-stage breast cancer patients, who receiving single-fraction very accelerated partial breast irradiation, as postoperative radiation therapy.

Radiation: single-fraction very accelerated partial breast irradiation

Interventions

single-fraction very accelerated partial breast irradiation RADIATION

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

single-fraction very accelerated partial breast irradiation arm

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: We can only treat female breast cancer patients with this technique.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Oncology, Hungary: lead

Study Sites (22)

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

Related Publications (5)

• 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.

  PMID: 33831490 BACKGROUND

• 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.

  PMID: 38460552 BACKGROUND

• 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.

  PMID: 31767533 BACKGROUND

• 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.

  PMID: 39321957 BACKGROUND

• 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.

  PMID: 36738756 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Viktor Smanykó, MD

  National Institute of Oncology, Budapest, Hungary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Viktor Smanykó, MD

CONTACT

+3612248600; smanyko.viktor@oncol.hu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 16, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2032
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From treatment to the end of the 5-year follow-up period
• Access Criteria: The data will be accessible to the study leader and the mathematician who prepares the statistics. The data will be transmitted encrypted to the data processing center.

Locations

DE (5); PT (1); FR (3); CH (1); SE (1); PL (5); ES (4); LI (1); HU (1)