Discovery - University of Dundee - Online Publications

Library & Learning Centre

The EORTC 10041/BIG 03-04 MINDACT trial is feasible

The EORTC 10041/BIG 03-04 MINDACT trial is feasible: Results of the pilot phase

Research output: Contribution to journalArticle

View graph of relations

Authors

  • Emiel Rutgers
  • Martine J. Piccart-Gebhart
  • Jan Bogaerts
  • Suzette Delaloge
  • Laura Van't Veer
  • Isabel Teresa Rubio
  • Giuseppe Viale
  • Alastair M. Thompson
  • Rodolfo Passalacqua
  • Ulrike Nitz
  • Anita Vindevoghel
  • Jean-Yves Pierga
  • Peter M. Ravdin
  • Gustavo Werutsky
  • Fatima Cardoso

Research units

Info

Original languageEnglish
Pages2742-2749
Number of pages8
JournalEuropean Journal of Cancer
Journal publication dateDec 2011
Volume47
Issue18
DOIs
StatePublished

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. (C) 2011 Published by Elsevier Ltd.

Documents

Library & Learning Centre

Contact | Accessibility | Policy