Introduction
A phase III multi-center trial to compare ETC vs. EC-TX and Ibandronate vs. observation in patients with node-positive primary breast cancer
The last patient was brought in on 24.07.2008 by the Center 505 Westpfalz-Klinikum Kaiserslautern.
A Intergroup-Studie of the
News
The GAIN-Study is closed. End of recruitment 24.07.2008. This study included 3023 patients.
Design
Prospective, multi-center, controlled, non blinded, randomized phase III study with 2x2 factorial design.
A total of 3000 patients (i.e. 1500 patients per arm for ETC and EC-TX, 2000 patients for ibandronate treatment and 1000 for observation) will be enrolled in the study.
Boards
Protocol Board
- Prof. Dr. I. J. Diel, Mannheim
- Prof. Dr. D. Elling, Berlin (NOGGO)
- Prof. Dr. N. Harbeck, München (GBG)
- Prof. Dr. Ch. Jackisch, Offenbach (GBG)
- Prof. Dr. G. von Minckwitz, Frankfurt (GBG)
- Prof. Dr. V. Möbus, Frankfurt (AGO) (Leiter der klinischen Prüfung nach AMG)
- Prof. Dr. Ch. Thomssen, Halle (AGO)
- Prof Dr. M. Untch, Berlin (AGO)
Advisory Board
- Prof. Dr. Bender, Uniklinik, Düsseldorf
- Prof. Dr. J. Dunst, Uniklinik Lübeck
- Prof. Dr. G. Gitsch, Uniklinik Freiburg
- Prof. Dr. F. Jänicke, Uniklinik Eppendorf, Hamburg
- Prof. Dr. M. Kaufmann, Uniklinik Frankfurt
- Prof. Dr. M. Kiechle, Klinikum rechts der Isar der TUM, München
- Prof. Dr. R. Kimmig, Uniklinik Essen
- Prof. Dr. R. Kreienberg, Uniklinik Ulm
- Prof. Dr. U. Wagner, Uniklinik Marburg
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Contact
Project management
gain@gbg.de
+4961027480440