MEETING OF THE QASDG CLINICAL RESEARCH SUBGROUP European Commission Initiative on Breast Cancer (ECIBC) Varese, ITALY, 22 November 2016.

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1 EUROPEAN COMMISSION DIRECTORATE GENERAL JOINT RESEARCH CENTRE Directorate F Health, Consumers and Reference Materials Unit F1 Health in Society MEETING OF THE CLINICAL RESEARCH SUBGROUP European Commission Initiative on Breast Cancer (ECIBC) Varese, ITALY, 22 November 2016 Minutes Document history Version Date Drafted by Comments 0 06/12/2016 Silvia DEANDREA and Nadya DIMITROVA To be reviewed and approved by the participants 1 15/12/2016 Silvia DEANDREA Approved Page: 1 of 5

2 Tuesday 22 November :30 18:30 Clinical Research subgroup meeting List of participants is reported in ANNEX I The meeting was chaired by Giorgio STANTA Purpose of the meeting: To updated members of the Clinical Research subgroup on the outcomes of the teleconference between the subgroup's coordinator and the GDG Diagnosis subgroup editors (A. Lebeau, C. Quinn, P. Giorgi Rossi) and make decision on the steps forward. Giorgio Stanta made a presentation on the current perspectives of clinical research for breast cancer and also shared with the group the comments received by an absent subgroup member (Tibot Tot). The presentation is available on CIRCABC. The main points were: Identification of "second level centers": at European level the organisation of breast cancer care is very diverse. The participants to the meeting reported different experiences and models, from countries where all the centres must be able to treat every breast cancer case (e.g. Sweden) to contexts where the "comprehensive cancer centre" model is prevalent (e.g. OECI accreditation) to areas where a "hub-andspoke" model is applied. The group discussed also on the new perspectives offered by biobanks, that allows the possibility to have a tissue (sample/specimen) moving e.g to a reference centre, and not the patient. The underlined that a definition of an organisation model for breast cancer care at European level is out of the scope of this project, although it should be taken into account already from the piloting the possibility that some breast centres may not be able to treat specific breast cancer cases for several reasons: too complex, too costly, etc. Having a list of "special cases" for which it may be acceptable (or may be not) a referral to a second level centre would be useful already at this stage of the project Identification of breast cancer "special cases": the group discussed on the identification of these "special cases". Giorgio Stanta presented the opinion of Tibor Tot, stating that a meeting organised by the EC stated that breast cancer sarcomas and breast hematologic malignancies should be treated in second level institutions. Then the group discussed whether a predictors may be identified in order to select other kinds of breast cancer (e.g. in BRCA women, HER+ cases etc.) but without coming to a decision. It also seemed that a literature search on this topic would not be helpful. Then, the discussion moved to the identification of tests and technologies that should be provided in second level only and/or in structures with a special accreditation for this (e.g. OECI). Giorgio Stanta mentioned exome sequencing, plasma level DNA and liquid biopsies as test that may fall under this category. As accreditation of testing activities within the ECIBC is discussed in the Testing subgroup, the suggested bringing this proposal at that table. PICO question: the subgroup considered as relevant issuing a PICO question on the impact of clinical research on breast cancer women outcomes (i.e. does the presence of a research activity in a hospital improve certain outcomes vs. hospital without a significant research activity?). CCIb highlighted that it is not sure that a PICO question like this will retrieve a sufficient number of suitable studies, but as the group agreed on the relevance of the question a tentative will be made. Page: 2 of 5

3 The subgroup also raised issues on research at a general level (e.g. how women are informed, informed consent, etc.). The European QA scheme's requirements are discussed and selected via Delphi rounds. The will investigate with IQ Healthcare a way to have such requirements discussed in one of the planning rounds. Action points Action Timeline Who Raise the issue of special accreditation of high specialisation tests within the Testing subgroup Investigate with IQ Healthcare the feasibility of the discussion of research questions in Delphi rounds Investigate with CCIb the feasibility of a PICO question on research Provide a list with "special/rare breast cancer cases" for which it may be acceptable a referral to an expert/ second level centre As soon as a new version of the list of pathology testing for the European QA scheme is distributed to the subgroup January 2017 January 2017 End of January 2017 Giorgio Stanta Giorgio Stanta Page: 3 of 5

4 ANNEX I: List of participants NAME SURNAME David RIGAU CCIb Luigi CATALIOTTI Silvia Nadya Daniele Paolo Vitor Francesco Giorgio Maggie DEANDREA DIMITROVA GENERALI GIORGI ROSSI RODRIGUES SARDANELLI STANTA WILCOX GDG Page: 4 of 5

5 ANNEX II Meetings Notes - Teleconference between and Giorgio Stanta, Paolo Giorgi Rossi, Annette Lebeau and Cecily Quinn (8 November 2016) During the teleconference it was discussed: 1. The possibility that some breast lesions (B3) and/or breast cancer subtypes may need further research, or may benefit from services or treatment offered by centers with particular expertise in clinical research, bioinformatics, etc. 2. If this implies the need of a second level network of services offering this kind of facilities is still an open issue, also depending on the organisation of care in a specific country, the resources available, etc. It has been agreed that a systematic review aimed at identifying the cases falling under point 1. would form the basis for any future discussion. Therefore, the next Clinical Research Subgroup meeting will have as a goal the definition of this systematic review. Paolo gave his availability to attend that meeting, while Annette and Cecily will be engaged with the Testing -Pathology meeting. The will brief CCIb in advance, so that someone from their team can come to the meeting and help to define the systematic review's specifications. Page: 5 of 5