RecruitingNot ApplicableNCT07067437

Single-Fraction Very Accelerated Partial Breast Irradiation (sfVAPBI)

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

Sponsor

National Institute of Oncology, Hungary

Enrollment

250 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Neoplasms

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.

Eligibility

Sex: FEMALEMin Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether delivering a full course of targeted radiation to early-stage breast cancer in a single treatment session (rather than multiple sessions over several weeks) is equally safe and effective — a method called single-fraction very accelerated partial breast irradiation. **You may be eligible if...** - You are over 40 years old with early-stage breast cancer (stage 0, I, or II) with a tumor smaller than 3 cm - You have already had surgery and there are no cancer cells at the surgical margins - Your cancer has not spread to the lymph nodes (or only minimally) - Your cancer is a hormone-sensitive type (Luminal A or B) - Surgery was completed within the past 20 weeks **You may NOT be eligible if...** - You have stage III or IV breast cancer - You have triple-negative breast cancer - You carry a BRCA1 or BRCA2 gene mutation - You have had previous breast cancer or are currently pregnant - You received chemotherapy before surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONsingle-fraction very accelerated partial breast irradiation

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

Locations(22)

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

Maria Skłodowska-Curie Bialystok Oncology Center

Bialystok, Poland

Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny

Brzozów, Poland

National Institute of Oncology

Gliwice, Poland

Greater Poland Cancer Centre

Poznan, Poland

Lower Silesian Oncology, Pulmonology and Hematology Center

Wroclaw, Poland

Instituto Português de Oncologia do Porto

Porto, Portugal

Oncology Institute Vojvodina

Kamenica, Serbia

Fundacion IMOR's Oncology Clinic

Barcelona, Spain

Institut Catala d'Oncologia

Barcelona, Spain

Hospital Universitario de Navarra

Pamplona, Spain

Instituto Valenciano de Oncologia

Valencia, Spain

Inselspital, Universitätsspital Bern

Bern, Switzerland

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NCT07067437

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