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EORTC, BIG, and Agendia Announce Completion of Patient Recruitment for International MINDACT Study
Date:10/18/2011

BRUSSELS, IRVINE, California, and AMSTERDAM, October 18, 2011 /PRNewswire/ --

The EORTC, BIG, and Agendia, a commercial-stage molecular cancer diagnostics company, today announced the completion of patient registration for the EORTC 10041/BIG3-04 MINDACT (Microarray In Node negative and 1-3 positive lymph node Disease may Avoid Chemotherapy Trial) study. More than 6,600 patients in 111 institutions across nine countries were enrolled from February 2007 to July 2011 in this trial.

Genomic risk profiling lies at the heart of personalized management of cancer.  MINDACT is investigating the added clinical value of MammaprintTM to standard clinicopathological criteria for the accurate selection of breast cancer patients for adjuvant chemotherapy. The study aims to provide further evidence that early breast cancer patients with a low recurrence risk genomic profile by Mammaprint® may not need chemotherapy.  This would spare patients from burdensome side effects without increasing the risk of metastasis or reducing survival. The study is also designed to show whether MammaPrint® can predict patient response to specific therapies.

Commercialized by Agendia, MammaPrint® has been cleared by the FDA as a prognostic tool identifying patients at low risk of metastasis, and can already be used across the spectrum of breast cancer cases for this purpose (including ER positive and negative, and lymph node negative and positive). It is being tested in MINDACT to provide large-scale prospective validation of its clinical utility.

"The completion of patient recruitment is a major milestone for this groundbreaking trial. If MammaPrint® is ultimately shown to predict individual patient response to the trial specific cancer therapies currently on the market, it will likely create significant and valuable synergies for the manufacturers
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SOURCE Agendia B.V.
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