Single-Fraction Very Accelerated Partial Breast Irradiation (sfVAPBI) (sfVAPBI)

July 5, 2025 updated by: Viktor Smanykó, MD, PhD, National Institute of Oncology, Hungary

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lyon, France
      • Nancy, France
        • Not yet recruiting
        • Institut de Cancerologie de Lorraine
        • Contact:
        • Principal Investigator:
          • Marie Bruand, MD
      • Nice, France
  • Germany
      • Bremerhaven, Germany
      • Erlangen, Germany
        • Not yet recruiting
        • University Hospital Erlangen
        • Principal Investigator:
          • Vratislav Strnad, MD
        • Contact:
      • Lübeck, Germany
        • Not yet recruiting
        • UNIVERSITÄTSKLINIKUM Schleswig-Holstein
        • Contact:
        • Principal Investigator:
          • Tamer Soror, MD
      • Offenbach, Germany
        • Not yet recruiting
        • Sana Klinikum Offenbach
        • Contact:
        • Principal Investigator:
          • Peter Niehoff, MD
      • Würzburg, Germany
        • Not yet recruiting
        • Universitätsklinikum Würzburg
        • Contact:
        • Principal Investigator:
          • Büllent Polat, MD
  • Hungary
      • Budapest, Hungary
        • Recruiting
        • National Institute of Oncology
        • Contact:
        • Principal Investigator:
          • Viktor Smanykó, MD
  • Lithuania
      • Vilnius, Lithuania
        • Not yet recruiting
        • National Cancer Institute
        • Contact:
        • Principal Investigator:
          • Justinas Jonusas, MD
  • Poland
      • Białystok, Poland
        • Not yet recruiting
        • Maria Skłodowska-Curie Bialystok Oncology Center
        • Contact:
        • Principal Investigator:
          • Dorota Kazberuk, MD
      • Brzozów, Poland
        • Not yet recruiting
        • Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny
        • Contact:
        • Principal Investigator:
          • Damian Kazalski, MD
      • Gliwice, Poland
        • Not yet recruiting
        • National Institute of Oncology
        • Principal Investigator:
          • Magdalena Stankiewicz, MD
        • Contact:
      • Poznań, Poland
        • Not yet recruiting
        • Greater Poland Cancer Centre
        • Contact:
        • Principal Investigator:
          • Adam Chicel, MD
      • Wrocław, Poland
        • Not yet recruiting
        • Lower Silesian Oncology, Pulmonology and Hematology Center
        • Contact:
        • Principal Investigator:
          • Katarzyna Konat-Bąska, MD
  • Portugal
      • Porto, Portugal
  • Serbia
      • Kamenica, Serbia
        • Not yet recruiting
        • Oncology Institute Vojvodina
        • Contact:
        • Principal Investigator:
          • Olivera Ivanov, MD
  • Spain
      • Barcelona, Spain
        • Not yet recruiting
        • Institut Catala d'Oncologia
        • Contact:
        • Principal Investigator:
          • Cristina Gutierrez-Miguelez, MD
      • Barcelona, Spain
        • Not yet recruiting
        • Fundacion IMOR's Oncology Clinic
        • Contact:
        • Principal Investigator:
          • Benjamin Guix, MD
      • Pamplona, Spain
        • Not yet recruiting
        • Hospital Universitario de Navarra
        • Contact:
        • Principal Investigator:
          • Irene Martínez, MD
      • Valencia, Spain
        • Not yet recruiting
        • Instituto Valenciano de Oncologia
        • Contact:
        • Principal Investigator:
          • Jose-Luis Guinot, MD
  • Switzerland
      • Bern, Switzerland
        • Not yet recruiting
        • Inselspital, Universitätsspital Bern
        • Contact:
        • Principal Investigator:
          • Kristina Lössl, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single-fraction very accelerated partial breast irradiation arm
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
Adjuvant accelerated partial breast brachytherapy, with interstitial multicatheter technique, in one fraction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence (5-year actuarial rate) of ipsilateral breast recurrence (IBR)
Time Frame: From treatment to the end of the fifth year of follow-up.
From treatment to the end of the fifth year of follow-up.
Incidence (5-year actuarial rate) of regional relapse (RR)
Time Frame: From treatment to the end of the fifth year of follow-up.
From treatment to the end of the fifth year of follow-up.
Incidence (5-year actuarial rate) of contralateral breast cancer (CBC)
Time Frame: From treatment to the end of the fifth year of follow-up.
From treatment to the end of the fifth year of follow-up.
Incidence (5-year actuarial rate) of distant metastasis (DM)
Time Frame: From treatment to the end of the fifth year of follow-up.
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)
Time Frame: From treatment to the end of the fifth year of follow-up.
From treatment to the end of the fifth year of follow-up.
Incidence (5-year actuarial rate) of breast cancer death for cause specific survival (CSS)
Time Frame: From treatment to the end of the fifth year of follow-up.
From treatment to the end of the fifth year of follow-up.
Incidence (5-year actuarial rate) of death by any cause for overall survival (OS)
Time Frame: From treatment to the end of the fifth year of follow-up.
From treatment to the end of the fifth year of follow-up.
Incidence of acute side effects
Time Frame: From treatment to the end of the first 3 months of follow-up.
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 treatment to the end of the first 3 months of follow-up.
Cosmetic results at 5 years
Time Frame: From treatment to the end of the fifth year of follow-up.
Cosmetic results based on the Harvard criteria (excellent, good, fair, poor).
From treatment to the end of the fifth year of follow-up.
Quality of Life (QoL)
Time Frame: From treatment to the end of the fifth year of follow-up.
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)
From treatment to the end of the fifth year of follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Oncology, Hungary

Investigators

  • Principal Investigator: Viktor Smanykó, MD, National Institute of Oncology, Budapest, Hungary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

August 1, 2032

Study Registration Dates

First Submitted

June 25, 2025

First Submitted That Met QC Criteria

July 5, 2025

First Posted (Actual)

July 16, 2025

Study Record Updates

Last Update Posted (Actual)

July 16, 2025

Last Update Submitted That Met QC Criteria

July 5, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEC-ESTRO sfVAPBI
  • 1012 (Registry Identifier: NNGYK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

From treatment to the end of the 5-year follow-up period

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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