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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
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.
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.
Age
40 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Centre Léon Bérard
Lyon, France
Institut de Cancérologie de Lorraine
Nancy, France
Antoine Lacassagne Cancer Centre
Nice, France
Klinikum Bremerhaven
Bremerhaven, Germany
University Hospital Erlangen
Erlangen, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Germany
Sana Klinikum Offenbach
Offenbach, Germany
Universitätsklinikum Würzburg
Würzburg, Germany
National Institute of Oncology
Budapest, Hungary
National Cancer Institute
Vilnius, Lithuania
Start Date
July 1, 2025
Primary Completion Date
July 1, 2027
Completion Date
August 1, 2032
Last Updated
July 16, 2025
250
ESTIMATED participants
single-fraction very accelerated partial breast irradiation
RADIATION
Lead Sponsor
National Institute of Oncology, Hungary
NCT07191730
NCT06312176
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06797635