Giuseppe Viale, MD, PhD

2009-2010 BCRF Project:
The Breast International Group and TRANSBIG, Brussels, Belgium
(made possible by generous support from Roche)
Co-investigators: Martine Piccart-Gebhart, MD, PhD, Jules Bordet Institute; Fatima Cardoso, MD, Jules Bordet Institute; Phillippe Bedard, MD, Jules Bordet Institute; Laura van 't Veer, PhD, Netherlands Cancer Institute

In February 2007 an international research network known as the TRANSBIG Consortium launched the innovative MINDACT clinical trial (Micro array In Node negative and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy). The goal of this trial is to determine if a new test should be used to help doctors decide upon the best treatment for women diagnosed with early stage breast cancer. This new test, known as the 70-gene signature (or MammaPrint™), analyzes the genes of a patient's tumor to see if a cancer is likely to come back (in which case treatment with chemotherapy after surgery is probably needed) or not (in which case chemotherapy can safely be avoided).

MINDACT is an ongoing complex multinational clinical trial that has been recruiting patients since March 2007 and is now recruiting about 140 patients per month. The trial had a predefined "pilot phase" consisting on the first 800 patients enrolled. This important milestone was achieved in November 2008. Since the trial is contingent upon the comparison of the 70-gene signature with the standard clinical and pathological risk factors that doctors routinely use to decide whether a patient should be treated with chemotherapy, it is important to ensure that the pathological assessment of tumor specimens is consistent across the centers participating in the study. Previous studies have shown that there may be discrepancies in the assessment of histological grading, hormonal receptor status and HER-2 protein overexpression and/or gene amplification in up to 20% of cases between different pathological laboratories.

The goal of the current study is to retest the key pathological characteristics of the first 800 patients enrolled in the trial in a high quality pathology laboratory and evaluate how discrepancies in pathological assessment with local testing may affect the underlying assumptions for the ongoing MINDACT trial. In addition, the traditional pathological assessment of key markers at the protein level will be compared with expression of the gene using a new technology known as whole genome microarray. Ultimately, the hope is that in the future doctors can reliably distinguish women with breast cancer who can be spared unnecessary chemotherapy with those who need additional therapy to prevent a recurrence of their breast cancer.

Mid-Year Progress Report:
With the present study the researchers aim at evaluating the quality of the pathologic assessment of the tumors of patients enrolled in the MINDACT trial. Ensuring high quality pathological assessment is essential to the success of the MINDACT trial, since discrepancies in pathological marker assessment may change an individual patient’s clinical risk assignment from low to high risk or vice-versa with important consequences on treatment allocation and the ultimate interpretation of the findings of the study. With the support of BCRF the central pathology review of the first 800 patients enrolled in MINDACT has started.

Bio:
Education and Licences:
>M.D. degree at the University of Milan School of Medicine (1976)
>Specialisation in Pathology and Laboratory Medicine (1979).
>Member of the Royal College of Pathologists (MRCPath) (1987-1997) and Fellow (FRCPath) since1997

Academic Appointments:
>1994- : Professor of Pathology and Chairman, University of Milan School of Medicine
>2001- : Director of the Post-graduate Medical School in Pathology, University of Milan School of Medicine
>2001-: Director of the Master Course in "Senology" , University of Milan School of Medicine
>1987-1994: Associate Professor of Pathology, University of Milan School of Medicine.

Hospital Appointments:
>1994- : Director, Department of Pathology and Laboratory Medicine, European Institute of Oncology
>1981-1994: Deputy-director, Department of Pathology, S. Paolo Hospital
>1978-1981: Staff pathologist, department of Pathology, S. Raffaele Hospital (1978-1981) and S. Paolo Hospital (1981)

Other Appointments:
>2007- : Member of the AJCC working group for the TNM classification of breast cancer
>2007- : Member of the Pathology Sub-study Group of the Intergroup Exemestane Study (PathIES)
>2007- : Member of the Executive and Steering Committees of the ALTTO trial, co-chair of the International Pathology Committee and responsible for the Central Pathology Laboratory for non-US Centers
>2006- : Member of the FFPE Working Group of the Breast International (BIG) and National Cancer Institute (NCI)-sponsored breast cancer Cooperative Groups
>2005- : Chairman of the Biological Protocol Working Group of the IBCSG
>2005- : Member of the Early Breast Cancer Trialists’ Collaborative Group Steering Committee
>2004- : Founding Member of the International Sentinel Node Society
>2004- : Co-chair of the Translational Research Committee of the BIG2-98 trial (Trans-TAX)
>2004- : Member of the Executive and Steering Committees of the Breast International Group (BIG) and of the MINDACT trial
>2004- : Vice-President for Europe of the Senologic International Society
>2002- : Member of the Translational Research Committee of the HERA trial
>2002- : Member of the Scientific/Translational Research Committee of the Breast International Group (BIG)
>2001-2003: Member of the Scientific Committee of the Italian National Institute of Health
>2001- : Co-chairman of the Central Pathology Office of the International Breast Cancer Study Group (IBCSG)
>1997- : Member of the Scientific Committee of the International Breast Cancer Study Group (IBCSG)
>1994-1998: Director of the European School of Pathology

Record of Publications:
Prof. Viale authored 280 articles in indexed international Journals and 36 chapters in books.