Updated long-term MINDACT study results confirm the clinical utility of MammaPrint®

Last week, during the virtual edition of the American Society of Clinical Oncology (ASCO) congress attended by 42,750 cancer specialists from 138 countries, Dr Fatima Cardoso, breast cancer expert from the Breast International Group (BIG) network, presented updated results from the MINDACT clinical trial.

 

With very first results published in the prestigious New England Journal of Medicine in 2016, MINDACT, enrolling 6693 women with early stage breast cancer from 112 hospitals across 9 countries and 7 BIG research groups, showed that up to 46% of patients who would have received chemotherapy in the past could be spared this treatment and its side effects in the future.

 

 

This pioneering study, run in close collaboration with the European Organization for Research and Treatment of Cancer (EORTC), was able to demonstrate that using a sophisticated diagnostic test to study 70 genes (MammaPrint®) in patients’ tumours, in addition to the usual clinical and pathological information collected, could help doctors and patients to make better decisions about whether chemotherapy was really needed after surgery. 

Now, almost 5 years later, the updated results presented by Dr Cardoso continue to support the 2016 findings: the evidence remains strong that MammaPrint® adds very helpful information to the usual tests to help make decisions about whether chemotherapy and its side effects can be avoided by many women with breast cancer.

The test was shown to be particularly useful in decision-making for postmenopausal women, for whom chemotherapy added no benefit when MammaPrint® indicated low risk of the breast cancer coming back, even if the usual tests indicated high risk.  In younger women, chemotherapy may still add benefit, but this requires careful discussion between doctor and patient.

One of the main challenges in treating breast cancer today has become to accurately distinguish between patients who need post-surgery treatment and those who do not. This, together with the identification of the best type of therapy for each individual patient and the development of drugs targeting specific characteristics of tumour cells, are the goals of treatment tailoring or personalised medicine.

Since 2019, gene-expression profiling tests, such as MammaPrint®, are reimbursed by Belgian health insurance.

It is BIG’s mission to find ways of ensuring patients receive the treatments most appropriate for them. MINDACT can be considered one of the very first clinical trials to investigate how drug therapy may be more effectively – and safely – tailored to individual breast cancer patient’s needs.

MINDACT demanded tremendous collaborative efforts and demonstrates how our joining efforts have a direct impact on patients’ lives. Today, it is a successful example of how, by working together across borders and disciplines, we can develop better treatments – and eliminate those that are not needed – while increasing the likelihood of finding cures.

Clinical trials are very expensive and running MINDACT, a fully academic study, cost approximately 47 million Euro.  The funding for the trial was also the result of tremendous efforts by all the partners involved in order to secure educational grants and in-kind donations from a great many sources: the European Commission Framework Programme VI (FP6-LSHC-CT-2004-503426, “TRANSBIG Network of Excellence”); the Breast Cancer Research Foundation; educational grants from Novartis, F. Hoffman La Roche, Sanofi-Aventis, Eli Lilly, and Veridex;  the U.S. National Cancer Institute; the European Breast Cancer Council-Breast Cancer Working Group (BCWG grant for the MINDACT biobank); the Jacqueline Seroussi Memorial Foundation (2006 JSMF award); Prix Mois du Cancer du Sein (2004 award); Susan G. Komen for the Cure (SG05-0922-02); Fondation Belge Contre le Cancer (SCIE 2005-27); Dutch Cancer Society (KWF); Association Le Cancer du Sein, Parlons-en!; the Brussels Breast Cancer Walk-Run and the American Women’s Club of Brussels; NIF Trust; Deutsche Krebshilfe;  the Grant Simpson Trust; and Cancer Research UK. This trial was also supported by the EORTC Charitable Trust. Whole genome analysis was provided in-kind by Agendia. Without all this support, the study would never have been possible.

MINDACT is sponsored and run by the European Organisation for Research and Treatment of Cancer (EORTC) under the Breast International Group (BIG) umbrella, and many other partners, both from academia and the private sector, including the breast cancer patient advocacy network Europa Donna. The biotechnology company Agendia developed MammaPrint®.