MINDACT Overview

The success of the independent validation of MammaPrint by the TRANSBIG research consortium has justified the commencement of a large collaborative MINDACT trial. MINDACT aims to give a definitive answer as to the clinical relevance of MammaPrint, its performance compared to traditional prognostic factors and its ability to predict response to commonly prescribed adjuvant treatments.

MINDACT will enrol 6,000 breast cancer patients to determine the benefit/risk ratio of chemotherapy when the prognostic assessment based on clinical-pathological features differs from that provided by the gene signature. MammaPrint is used to classify early stage breast cancer patients as being at high or low risk of distant relapse. This assessment is compared to the “Adjuvant! Online” software risk assessment that is widely used in clinical practice today.

All 6,000 patients enrolled in the study will have their risk of recurrence assessed by traditional clinical-pathological methods and MammaPrint. Those patients classified as “high risk” by both methods will be offered adjuvant chemotherapy. Those patients classified as “low risk” by both methods will not be offered adjuvant chemotherapy, although they will be offered endocrine therapy if their tumors are endocrine responsive. Those patients for whom the two risk assessments are discordant will be randomized to receive treatment plans based on either clinical criteria (using Adjuvant! Online) or genomic prognosis (using MammaPrint).

Study design:

Impact

It is expected that 10% to 20% of women who would normally receive adjuvant chemotherapy based on their clinical-pathological factors will be spared the inconvenience and morbidity of this therapy, without having any negative impact on their survival. The primary objective of the trial is to confirm that the number of patients that can be spared adjuvant chemotherapy is significantly increased when the decision is based on MammaPrint rather than on the clinical-pathological criteria, while the critical group of patients who have a high risk of recurrence according to the clinical-pathological criteria but a low risk according to MammaPrint is not under-treated. This will have immense benefits for women and will markedly improve our ability to predict which patients are likely to experience a distant relapse and therefore require additional systemic therapy.

Given the immense therapeutic and emotional repercussions for women, it is essential to determine, in an unbiased way, the true value of gene signatures in clinical practice today. The evaluation of the clinical application of MammaPrint to individualize management, to spare treatment without compromising long term outcome and hence diminish the public health burden is of utmost priority to women and governments.

Coordination

MINDACT is coordinated by the European Organisation for Research and Treatment of Cancer (EORTC) and run under the Breast International Group (BIG) and TRANSBIG network.

MINDACT Contacts

Coordinating group

European Organization for Research and Treatment of Cancer (EORTC)
Avenue Mounierlaan 83/11
B-1200 Brussels, Belgium
Tel: +32 2 774 16 11

www.eortc.be

Breast International Group (BIG)
Institut Jules Bordet / 121 Blvd de Waterloo, 7th floor
B-1000 Brussels, Belgium
Tel: +32 2 541 3526

www.breastinternationalgroup.org

Study Coordinators:

Emiel J.T. Rutgers, MD, PhD, FRCS EORTC
Martine J. Piccart-Gebhart, MD, PhD Institut Jules Bordet
Fatima Cardoso, MD Institut Jules Bordet

Collaborative groups:

FNCLCC Fédération nationale des centres de lute contre le cancer
GOIRC Italian oncology group for clinical research
IBCSG International Breast Cancer Study Group
ICORG Ireland Cooperative Oncology Research Group
SAKK Swiss Group for Clinical Cancer Research
SOLTI Grupo Español de Estudio y Tratamiento de Intensificación en Tumores Sólidos
BOOG Borstkanker Onderzoeks Groep Nederland
WSG Westdeutsche Studien Gruppe

MNDACT Locations

Belgium:
Institut Jules Bordet, Brussels
Cliniques Universitaires St. Luc, Brussels
ZNA Middelheim, Antwerp
Universitair Ziekenhuis Antwerpen, Edegem
Cliniques Universitaires De Mont Godinne , Yvoir
Clinique Sainte Elisabeth, Namur
Algemeen Ziekenhuis Sint-Augustinus, Wilrijk
Campus Maria's Voorzienigheid, Kortrijk
H. Hartziekenhuis, Roeselare
Hopital De Jolimont Haine, St Paul

France:
Institut Curie, Paris
Institut Gustave Roussy, Villejuif
Centre Georges-Francois-Leclerc, Dijon
Centre Eugene Marquis, Rennes
Centre Paul Papin, Angers
Claudius Regaud Institute, Toulouse
Centre Hospitalier René Dubos, Pontoise
C.H. De Mulhouse - Hopital Emile Muller-Moenchsberg, Mulhouse
Centre Regional Francois Baclesse, Caen
Centre Antoine Lacassagne, Nice
Centre Jean Godinot, Reims
Centre Leon Berard, Lyon
Institut Bergonie, Bordeaux
Centre Rene Gauducheau, Nantes - St. Herblain
Centre Jean Perrin, Clermont-Ferrand
Centre Alexis Vautrin, Vandoeuvre-Les-Nancy
Centre Rene Huguenin, Saint-Cloud
Institut J. Paoli & I., Calmettes

Netherlands:
Nederlands Kanker Instituut-AvL, Amsterdam
Onze Lieve Vrouwe Gasthuis, Amsterdam
Spaarne Ziekenhuis Hoofddorp
Medisch Centrum Alkmaar, Alkmaar
Medisch Centrum Leeuwarden-Zuid, Leeuwarden
Diakonessenhuis, Utrecht
Leids Universitair Medsich Centrum, Leiden
Rijnstate Ziekenhuis, Arnhem
Atrium Medisch Centrum, Heerlen
Meander Medisch Centrum, Amsterfoort
Jeroen Bosch Ziekenhuis, 's Hertogenbosch
Medisch Centrum Haaglanden – Westeinde, Den Haag Waterlandziekenhuis Purmerend, Purmerend
Rijnland Ziekenhuis, Leiderdorp
Ziekenhuisgroep Twente - Twenteborg Ziekenhuis, Almelo
Deventer Ziekenhuizen, Deventer
Ziekenhuis Nij Smellinghe, Drachten

Germany:
Ev. Bethesda Krankenhaus, Moenchengladbach
Marienhospital Witten, Witten
St Elisabeth-Krankenhaus, Koeln

United Kingdom:
University of Dundee - Ninewells Hospital, Dundee, Scotland

Italy:
Ospedale Civile Rimini, Rimini

Spain:
Hospital Universitario ‘12 de Octubre’, Madrid
Institut Catala D Oncologia, Girona
Institut Catala D'Oncologia L'Hospitalet Barcelona
Hospital De La Santa Creu I Sant Pau, Barcelona
Hospital General Vall D'Hebron, Barcelona
Hospital Clinico Universitario De Valencia, Valencia
Hospital Son Llatzer, Palma De Mallorca
Hospital Son Dureta, Palma De Mallorca

Slovenia:
The Institute Of Oncology, Ljubljana
University Medical Center Maribor, Maribor

Switzerland:
Centre Hospitalier Universitaire Vaudois (Lausanne, Switzerland)

MNDACT General Information

For protocol and general information regarding the MINDACT trial, please contact:

Jillian Harrison (Project Manager) - EORTC, Brussels

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, +32 2 7741051

Frédéric Henot (Project Manager) - EORTC, Brussels

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, +32 2 7741655

Carine Pontegnies (Project Manager) - EORTC, Brussels

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, +32 2 7741023
or EORTC at

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For information on the MammaPrint assay, please contact:

Agendia BV at +31 20 462 1500

INFORMATION

Please visit http://clinicaltrials.gov for additional information, including eligibility criteria and a schema of the pre-registration, registration and randomization process. Refer to this study by its ClinicalTrials.gov identifier:
NCT00433589.

SPONSORING

EORTC is the legal European Sponsor for the MINDACT trial, unless otherwise specified for legal or logistical reasons.

Financial support has primarily been provided by:

Industrial partners Novartis
F. Hoffman La Roche
Sanofi-Aventis
The European Commission Framework Programme VI (FP6-LSHC-CT-2004-503426),
the NCI (through the EORTC) and Charitable trusts including the Breast Cancer Research Foundation,
the Jacqueline Seroussi Memorial Foundation and
the Prix Mois du Cancer du Sein.