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

Publication Name: EUROPEAN JOURNAL OF CANCER

Author(s): Emiel Rutgers, Martine J. Piccart-Gebhart, Jan Bogaerts, Suzette Delaloge, Laura Van ‘t Veer

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 Mamma-Print 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/Glow, 198 (24.8%) as C-high/G-high, 75 (9.4%) as C-low/G-high and 141 (17.6%) as C-high/G-

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