EORTC protocol 10031 - IBCSG 24-02

A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer tamoxifen versus ovarian function suppression + tamoxifen versus ovarian function suppression + exemestane (SOFT).
Trial StatusOpen
DatesDate of activation: 14/01/2004
Data management at EORTCMailbox
Phase3
Randomized trialYes
TypeAdjuvant
Targeted Sample sizeEORTC Groups: 360 - All Groups: 3000
Number of steps1
DrugExemestane (FCE 24304)
Triptorelin
Tamoxifen
Study StaffMarc Debled (Study Coordinator) - Institut Bergonie, Bordeaux
Jan Bogaerts (Statistician) - EORTC, Brussels
Peter De Burghgraeve (Data Manager) - EORTC, Brussels
Yue Song (Project Manager) - EORTC, Brussels, yue.song( at )eortc.be, +32 2 7741628
Type of cancerBreast
Participating GroupsInternational Breast Cancer Study Group(Coordinating Group)
EORTC Breast Cancer Group
Oncology Site Management Organization
Currently authorized centers ZNA Middelheim (Antwerpen, Belgium) - Inst. 114
Cliniques Universitaires St. Luc (Brussels, Belgium) - Inst. 121
Centre Hospitalier Etterbeek Ixelles (Brussels, Belgium) - Inst. 127
U.Z. Gasthuisberg (Leuven, Belgium) - Inst. 147
C.H.U. Sart-Tilman (Liege, Belgium) - Inst. 155
Hopital De Jolimont (Haine St Paul, Belgium) - Inst. 474
H. Hartziekenhuis (Roeselare, Belgium) - Inst. 1200
Clinique Sainte Elisabeth (Namur, Belgium) - Inst. 1201
Algemeen Ziekenhuis Sint-Augustinus (Wilrijk, Belgium) - Inst. 1234
Clinique Hartmann (Neuilly-Sur-Seine, France) - Inst. 2299
Clinique De Valdegour (Nimes, France) - Inst. 2308
Polyclinique Bordeaux-Nord Aquitaine (Bordeaux, France) - Inst. 2359
Clinique Etienne Dolet (Saint Nazaire, France) - Inst. 9085
Clinique de l'Alliance (St Cyr sur Loire, France) - Inst. 9089
C.H.R.U. De Limoges (Limoges, France) - Inst. 469
Centre Henri Becquerel (Rouen, France) - Inst. 208
Centre Claudius Regaud (Toulouse, France) - Inst. 209
Centre Jean Godinot (Reims, France) - Inst. 219
Institut Gustave Roussy (Villejuif, France) - Inst. 225
Centre Leon Berard (Lyon, France) - Inst. 227
Institut Bergonie (Bordeaux, France) - Inst. 228
Centre Georges-Francois-Leclerc (Dijon, France) - Inst. 229
Centre Rene Gauducheau (Nantes - St. Herblain, France) - Inst. 235
Centre Jean Perrin (Clermont-Ferrand, France) - Inst. 241
Centre Rene Huguenin (Saint-Cloud, France) - Inst. 252
Institut Curie (Paris, France) - Inst. 259
Centre Eugene Marquis (Rennes, France) - Inst. 272
Hopital Jean Bernard (Poitiers, France) - Inst. 296
Assaf Harofeh Medical Center (Zerifin, Israel) - Inst. 3814
Rambam Medical Center (Haifa, Israel) - Inst. 910
I.P.O. Francisco Gentil - Centro De Lisboa (Lisboa, Portugal) - Inst. 801
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, The Netherlands) - Inst. 301
Onze Lieve Vrouw Gasthuis (Amsterdam, The Netherlands) - Inst. 309
Leiden University Medical Centre (Leiden, The Netherlands) - Inst. 310
Marmara University Hospital (Istanbul, Turkey) - Inst. 971
Protocol summaryLink provided by NCI PDQ
Back to Protocol section