title: The EORTC 10041/BIG 03-04 MINDACT trial is feasible: results of the pilot phase.
abstract: BACKGROUND
  The MINDACT (Microarray In Node-negative and 1-3 node positive Disease may Avoid ChemoTherapy) trial investigates the clinical utility of the 70-gene profile (MammaPrint) for the selection of breast cancer patients for adjuvant chemotherapy (CT) together with standard clinicopathological criteria. We present the results of the pilot phase consisting of first 800 patients included.
  
  
  METHODS
  MINDACT has enrolled 6600 patients, classified into high or low risk by MammaPrint and clinicopathological risk through Adjuvant! Online. Patients with both clinical (C) and genomic (G) high risks are offered adjuvant CT; those with both C and G low risks do not receive CT; patients with discordant risk are randomised for the decision of adjuvant CT based on C or G risk. CT randomisation of anthracycline-based versus docetaxel/capecitabine and endocrine therapy randomisation between letrozole and tamoxifen→letrozole are offered.
  
  
  RESULTS
  During the pilot phase 46% of screened patients were enrolled. Main reasons for non-enrolment were node positivity before trial amendment, sample quality problems and failure to meet logistic settings. Among the 800 patients, 386 (48%) were C-low/G-low, 198 (24.8%) as C-high/G-high, 75 (9.4%) as C-low/G-high and 141 (17.6%) as C-high/G-low. In total 216 (27%) cases were discordant. The difference between patients with C-high (42%) and G-high risk (34%) is 8.25% (95% confidence interval (CI), 4.7-11.8%; P<.0001). Compliance with the treatment decision was high (>92%).
  
  
  CONCLUSIONS
  The logistically complex MINDACT trial is feasible in a multinational setting. The proportion of discordant patients, the potential reduction in CT by using the genomic signature and compliance to treatment assignment are in accordance with the trial hypotheses.
authors: The Netherlands Cancer Institute, Department of Surgery, Amsterdam, The Netherlands. E.Rutgers@nki.nl
authors: Emiel
authors: E
authors: Rutgers
authors: Martine J
authors: MJ
authors: Piccart-Gebhart
authors: Jan
authors: J
authors: Bogaerts
authors: Suzette
authors: S
authors: Delaloge
authors: Laura Van 't
authors: LV
authors: Veer
authors: Isabel Teresa
authors: IT
authors: Rubio
authors: Giuseppe
authors: G
authors: Viale
authors: Alastair M
authors: AM
authors: Thompson
authors: Rodolfo
authors: R
authors: Passalacqua
authors: Ulrike
authors: U
authors: Nitz
authors: Anita
authors: A
authors: Vindevoghel
authors: Jean-Yves
authors: JY
authors: Pierga
authors: Peter M
authors: PM
authors: Ravdin
authors: Gustavo
authors: G
authors: Werutsky
authors: Fatima
authors: F
authors: Cardoso
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D005260:Female; D006801:Humans; D008875:Middle Aged; D010349:Patient Compliance; D010865:Pilot Projects