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“New England Journal of Medicine” publishes results of MINDACT clinical trial

“New England Journal of Medicine” publishes results of MINDACT clinical trial

The 70-gene test (Mammaprint®) can significantly reduce use of chemotherapy among breast cancer patients and has the potential to change clinical practice

26 Aug 2016

  • 46% of early stage breast cancer patients classified ashigh-risk by traditional methods can avoid chemotherapy

Brussels, 26 August 2016 - The prestigious “New England Journal of Medicine” published the primary outcome results of the MINDACT study. This breakthrough clinical trial is an example of international, academic, and multi-disciplinary leadership and achievement in breast cancer research. It is also a clear illustration of an integrated public, private and patient group collaboration.

The MINDACT trial results provide the highest level of evidence that using the 70-gene test (Mammaprint®) could change clinical practice by substantially de-escalating the use of adjuvant chemotherapy and sparing many patients a treatment that may cause toxicities, and will offer no to very little benefit.

What is MINDACT?
MINDACT stands for “Microarray In Node negative and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy”.

In summary, MINDACT provides evidence from a large-scale, prospective, randomised, controlled phase III international clinical trial for the value of integrating the 70-gene test (MammaPrint®) into clinical practice, which can now be considered in early breast cancer.

The results of the MINDACT clinical trial were presented for the first time by Dr Martine Piccart at the AACR Annual Meeting 2016 (American Association for Cancer Research, New Orleans, USA, April 2016). The aim of MINDACT – which enrolled 6693 breast cancer patients from 112 hospitals across 9 European countries – was to evaluate the added value of a test of 70 gene test (Mammaprint®) to the traditional method of assessing the likelihood of breast cancer recurrence for women with node-negative or 1-to-3 node positive breast cancer. The study results can help oncologists decide which of these patients will be able to safely avoid chemotherapy and the side effects that come with it.

Future research using the study’s biological sample collection can also contribute to a much deeper understanding of breast cancer and how to continue to improve treatment in the future.

MINDACT, an extensive and complex academically-driven international partnership
Sponsored by the European Organisation for Research and Treatment of Cancer (EORTC) as part of an extensive and complex academically-driven international partnership in collaboration with the Breast International Group (BIG), Europa Donna – the European Breast Cancer Coalition, Agendia (the company behind MammaPrint®, the 70-gene test), as well as many other academic and commercial partners, MINDACT is the first prospective translational research study of this magnitude in breast cancer to report the results of its primary objective.

MINDACT is an international, prospective, randomised, phase III study investigating the clinical utility of the 70-gene test, in addition to standard clinical-pathological criteria in selecting patients for adjuvant chemotherapy (CT). It was designed to compare the ability of the 70-gene signature MammaPrint® with the clinical risk assessment tool Adjuvant!Online in identifying those patients with node-negative or 1-to-3 node positive early-stage breast cancer who can be safely spared adjuvant chemotherapy without affecting their long term outcome (i.e. Distant Metastasis-Free Survival, DMFS).

The hypothesis that a considerable proportion of patients with LN0 or 1-3 LN+ early breast cancer can be safely spared adjuvant CT based on the biology of their disease was proven. The assay is useful in the group of patients characterised as high-risk per traditional clinical-pathological characteristics (clinical-high, or C-high), in which 46% are low-risk according to MammaPrint® (genomic-low or G-low) and can thus forego adjuvant CT.  C-high/G-low patients had a 5-year DMFS above 94%, independently of receiving or not CT.  The study set-up was challenging because of the numerous statistical, ethical, legal and intellectual property rights issues to be addressed at a time when genomic risk assessment assays were still new territory. Furthermore, the need to perform the test on fresh frozen material at the time of the trial (it can now be done on FFPE) led to complex logistics for the real-time collection and analysis of tumour tissue from 112 hospitals across 9 different countries. Notwithstanding these hurdles, the study successfully enrolled and treated 6693 early breast cancer patients, proving the feasibility of large, prospective, randomised, biomarker-focused trials, in a multinational setting.



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