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Standard or Hypofractionated Radiotherapy Versus Accelerated Partial Breast Irradiation (APBI) for Breast Cancer
Sponsor: UNICANCER
Summary
The standard treatment for localized breast cancer is based on conservative surgery (when possible) followed by radiation therapy (RT) delivered to the whole breast. The recommended total RT dose is 45 to 50 Gy delivered in 4.5 to 5 weeks followed by a 10 to 16 Gy boost to the tumor bed for 1 to 1.5 weeks. The rationale for the development of APBI was based on the difficulty for many patients to reach RT centers to receive standard whole breast irradiation (WBI) after conservative surgery. APBI offers decreased overall treatment time and several theoretical advantages over WBI, including a decrease in dose delivered to uninvolved portions of the breast and adjacent organs. If equivalence between the two treatments can be shown, then APBI will be considered as a historic evolution in breast cancer management. In this phase III trial, designed in postmenopausal women \>50 years of age, the objective is to compare the effectiveness and safety of APBI compared with whole breast irradiation. This study is also designed to ensure high quality criteria for surgery, pathology and RT techniques in the 3 arms and will allow to provide data on economics and costs.
Official title: Phase III Multicentric Trial Comparing Accelerated Partial Breast Irradiation (APBI) Versus Standard or Hypofractionated Whole Breast Irradiation in Low Risk of Local Recurrence of Breast Cancer
Key Details
Gender
FEMALE
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1006
Start Date
2010-12-27
Completion Date
2025-10
Last Updated
2025-05-14
Healthy Volunteers
No
Conditions
Interventions
Whole Breast Irradiation + Boost or Hypofractionated irradiation
Whole Breast Irradiation 50 Gy + Boost 16 Gy or Whole breast, either 40 Gy in 15 fractions in 3 weeks or 42.5 Gy in 16 fractions in 3 weeks
Accelerated partial breast irradiation
Tumor bed 40 Gy in 10 fractions, 2 fractions of 4 Gy per day in 5 to 7 days.
Locations (34)
Centre de traitement des Hautes energie - Clinique de l'Europe
Amiens, France
Centre Hospitalier Universitaire
Amiens, France
Institut Bergonié
Bordeaux, France
Centre Hospitalier
Brivé, France
Centre Francois Baclesse
Caen, France
CH Chambery
Chambéry, France
Hopital Henri Mondor
Créteil, France
Centre Leonard de Vinci
Dechy, France
CHU Michallon
Grenoble, France
Hôpital Robert Boulin
Libourne, France
Centre Oscar Lambret
Lille, France
CHU Dupuytren
Limoges, France
Centre Léon Bérard
Lyon, France
Institut Paoli Calmettes
Marseille, France
Clinique du Pont de Chaume
Montauban, France
Centre Hospitalier
Montélimar, France
CRLC Val d'Aurelle
Montpellier, France
Centre Hospitalier de Mulhouse
Mulhouse, France
Centre d'Oncologie de Gentilly
Nancy, France
Clinique Hartmann
Neuilly-sur-Seine, France
Centre de Haute Energie
Nice, France
Groupe Hospitalier Pitié Salpétrière
Paris, France
Hopital Tenon
Paris, France
Saint Louis Hospital
Paris, France
Centre Catalan d'Oncologie
Perpignan, France
Institut Jean Godinot
Reims, France
Centre Eugène Marquis
Rennes, France
CH de Roanne
Roanne, France
Centre Henri Becquerel
Rouen, France
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, France
Centre Paul Stauss
Strasbourg, France
Centre Marie Curie
Valence, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, France
Institut Gustave Roussy
Villejuif, France