title: Gene signature evaluation as a prognostic tool: challenges in the design of the MINDACT trial.
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.
authors.affiliation: Medical Oncology & Translational Research, Jules Bordet Institute, Boulevard de Waterloo 125, 1000 Brussels, Belgium.
authors.forename: Jan
authors.initials: J
authors.lastname: Bogaerts
authors.forename: Fatima
authors.initials: F
authors.lastname: Cardoso
authors.forename: Marc
authors.initials: M
authors.lastname: Buyse
authors.forename: Sofia
authors.initials: S
authors.lastname: Braga
authors.forename: Sherene
authors.initials: S
authors.lastname: Loi
authors.forename: Jillian A
authors.initials: JA
authors.lastname: Harrison
authors.forename: Jacques
authors.initials: J
authors.lastname: Bines
authors.forename: Stella
authors.initials: S
authors.lastname: Mook
authors.forename: Nuria
authors.initials: N
authors.lastname: Decker
authors.forename: Peter
authors.initials: P
authors.lastname: Ravdin
authors.forename: Patrick
authors.initials: P
authors.lastname: Therasse
authors.forename: Emiel
authors.initials: E
authors.lastname: Rutgers
authors.forename: Laura J
authors.initials: LJ
authors.lastname: van 't Veer
authors.forename: Martine
authors.initials: M
authors.lastname: Piccart
mesh_terms: D001943:Breast Neoplasms / Q000188:drug therapy / Q000235:genetics* / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D023381:Endpoint Determination; D005260:Female; D020869:Gene Expression Profiling; D006801:Humans; D015337:Multicenter Studies as Topic; D020411:Oligonucleotide Array Sequence Analysis; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D018401:Sample Size