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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/1994

Title: Gene signature evaluation as a prognostic tool: challenges in the design of the MINDACT trial
Authors: Bogaerts, J.
Cardoso, F.
BUYSE, Marc
Braga, S.
Loi, S.
Harrison, J. A.
Bines, J.
Mook, S.
Decker, N.
Ravdin, P.
Therasse, P.
Rutgers, E.
van't Veer, L. J.
Piccart, M.
Issue Date: 2006
Publisher: NATURE PUBLISHING GROUP
Citation: NATURE CLINICAL PRACTICE ONCOLOGY, 3(10). p. 540-551
Abstract: This Review describes the work conducted by the TRANSBIG consortium in the development of the MINDACT (Microarray In Node negative Disease may Avoid ChemoTherapy) trial. The goal of the trial is to provide definitive evidence regarding the clinical relevance of the 70-gene prognosis signature, and to assess the performance of this signature compared with that of traditional prognostic indicators for assigning adjuvant chemotherapy to patients with node-negative breast cancer. We outline the background work and the key questions in node-negative early-stage breast cancer, and then focus on the MINDACT trial design and statistical considerations. The challenges inherent in this trial in terms of logistics, implementation and interpretation of the results are also discussed. We hope that this article will trigger further discussion about the difficulties of setting up and analyzing trials aimed at establishing the worth of new methods for better selection of patients for cancer treatment.
Notes: Inst Jules Bordet, Chemotherapy Unit, B-1000 Brussels, Belgium. Free Univ Brussels, B-1050 Brussels, Belgium. Univ Texas, San Antonio, TX 78285 USA. Breast Int Grp, Brussels, Belgium. Netherlands Canc Inst, Amsterdam, Netherlands. Hasselt Univ, Diepenbeek, Belgium. IDDI, Diepenbeek, Belgium. Inst Jules Bordet, Dept Med, B-1000 Brussels, Belgium. EORTC, Res Ctr, Brussels, Belgium. EORTC, Ctr Data, Brussels, Belgium. EORTC, Breast Canc Grp, Brussels, Belgium. EORTC, Head & Neck Canc Grp, Brussels, Belgium.Cardoso, F, Inst Jules Bordet, Chemotherapy Unit, Blvd Waterloo 125, B-1000 Brussels, Belgium.fatima.cardoso@bordet.be
URI: http://hdl.handle.net/1942/1994
DOI: 10.1038/ncponc0591
ISI #: 000241054700007
ISSN: 1743-4254
Category: A1
Type: Journal Contribution
Validation: ecoom, 2007
Appears in Collections: Research publications

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