A BC. Advanced Breast Cancer. Br i d g i ng t h e G a p. Second International Consensus Conference. Conference Chairs: FINAL PROGRAMME

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1 A BC Br i d g i ng t h e G a p Advanced Breast Cancer 7-9 November 2013 partner journal Lisbon, Portugal Second International Consensus Conference dedicated media partner CancerWorld 50 September-October 2012 Conference Chairs: September-October 2012 Number 50 IT S FUTILE So why do we do it, and how can we stop? A NEW TOOL IN THE ARMOURY? Immunotherapies have never looked more promising Fatima Cardoso, PT Eric P. Winer, US Larry Norton, US Alberto Costa, IT/CH THE FATAL ALLURE OF ALTERNATIVE THERAPIES One woman s story of how she lost her chance to be cured FINAL PROGRAMME The ABC 2 guidelines will be developed by ESO and ESMO The ABC2 conference is held under the auspices of The ABC2 conference and guidelines are endorsed by FEDERACIÓN LATINOAMERICANA DE MASTOLOGIA SOCIÉTÉ INTERNATIONALE DE SÉNOLOGIE SENOLOGIC 7-9 INTERNATIONAL SOCIETY NOVEMBER 2013, LISBON, PORTUGAL ABC2 1

2 Advanced Breast Cancer Second International Consensus Conference A Phase 2 Study Investigating the PARP inhibitor, Veliparib, in Combination With Temozolomide or in Combination With Carboplatin and Paclitaxel in Subjects With BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer KEY INCLUSION CRITERIA: Men or women must be greater than or equal to 18 years of age Locally recurrent (not amenable to curative therapy) or Metastatic Breast Cancer BRCA1 or BRCA2 germline mutation KEY EXCLUSION CRITERIA: More than 2 prior lines of cytotoxic chemotherapy for metastatic disease Prior therapy with temozolomide, a platinum agent, or a PARP (Poly (ADP ribose) Polymerase) inhibitor. Prior taxane therapy for metastatic disease with exceptions A history of or evidence of brain metastases or leptomeningeal disease COUNTRIES: Australia, Argentina, Belgium, Brazil, Canada, Czech Republic, Denmark, Finland, France, Hungary, Israel, Netherlands, Norway, Poland, Romania, Russia, Slovakia, Spain, Sweden, Ukraine, United States BROCADESTUDY.COM ONCOLO(GY) ABC2 7-9 NOVEMBER 2013, LISBON, PORTUGAL A

3 CLINIPORATOR LEADING CLINICAL ELECTROPORATION Electrochemotherapy Effective, safe, simple. For local tumours control Before electrochemotherapy 10 weeks after electrochemotherapy CLINICAL INDICATIONS Melanoma and other skin tumors Local recurrences and cutaneous metastases from breast cancer Gehl J, EJC Supplements, Volume 4, N 11:35-37, 2006 Before electrochemotherapy 60 days after electrochemotherapy Head and neck cancers High response rate Preservation of normal tissue and organ function Efficacy in areas previously treated with radiation therapy Palliation of apinful, ulcerated or bleeding lesions Improved quality of life and cosmetic results Quaglino P, Annals Of Surgical Oncology. 15 (8): IGEA SpA, Carpi, Italy info@igeamedical.com 7-9 NOVEMBER 2013, LISBON, PORTUGAL ABC2 3

4 Advanced Breast Cancer Second International Consensus Conference Dear Colleagues, T he 1st International Consensus Conference for Advanced Breast Cancer (ABC1), which took place in Lisbon, Portugal in November 2011, brought together 800 participants from 64 countries worldwide to develop a set of consensus guidelines for the management of advanced breast cancer (ABC). Participants including health professionals, patient advocates and journalists agreed to a series of guidelines, which are based on the most up-to-date evidence and can be used to guide treatment decision making in diverse health care settings globally. ABC Consensus Conferences have the ambitious goal of improving outcomes for all patients with advanced breast cancer. We believe that, backed by strong political advocacy, ABC guidelines will raise standards of care, improve awareness about how best to meet the needs of this underserved group of patients, and help identify research priorities so that clinical research is focused on the most important areas of unmet need. The guidelines developed at ABC1 have been welcomed by a broad spectrum of professional and patient organizations active in breast cancer setting. Discussions are on-going with a number of international oncology societies regarding the endorsement of the guidelines that will greatly increase their impact globally. Furthermore, we are pleased to announce that the ABC2 guidelines will be developed in co-operation with ESMO and will be endorsed by EUSOMA, FLAM and SIS. The encouragement and positive feedback we have received from individual patients and professionals has emphasised the importance of this initiative and reinforced our belief that this effort is worth pursuing in the long term. It is therefore with great enthusiasm that we welcome you to the Advanced Breast Cancer Second International Consensus Conference (ABC2). ABC2 will have a specific additional program for breast cancer advocates coordinated by some of the major breast cancer advocacy groups worldwide. By working together we can change the dismal survival figures associated with ABC and improve the quality of life of all patients living with ABC worldwide. Fatima Cardoso, Eric P. Winer, Larry Norton and Alberto Costa ABC Conference Chairs 4 ABC2 7-9 NOVEMBER 2013, LISBON, PORTUGAL

5 Team Abstract submission Dolores Knupfer (2) Registration Laura Richetti (2) Accommodation and Optional tours Helder Carvalho (3) Organisation Roberta Ventura (1) Programme Secretariat Dolores Knupfer (2) Alexandra Zampetti (2) Exhibition, satellite symposia and sponsorship Chatrina Melcher (2) Communication Gabriele Maggini (2) 1 European School of Oncology Head Office Via Turati, Milano, Italy ph fx European School of Oncology Bellinzona Office Piazza Indipendenza Bellinzona, Switzerland ph fx Viagens Abreu SA Av. 25 de Abril, Linda-a-Velha, Portugal ph fx NOVEMBER 2013, LISBON, PORTUGAL ABC2 5

6 Advanced Breast Cancer Second International Consensus Conference A BC 3 Bridging the Gap Advanced Breast Cancer Chairs: F. Cardoso, PT L. Norton, US E. P. Winer, US A. Costa, IT/CH 5-7 November 2015, Lisbon, Portugal Third International Consensus Conference SAVE THE DATE R E C E I V E U P D A T E S A T : W W W. A B C - L I S B O N. O R G 6 ABC2 7-9 NOVEMBER 2013, LISBON, PORTUGAL dedicated media partner

7 General information Venue ABC2 will be held at the CCL - Centro de Congressos de Lisboa, Praça das Industrias, Lisbon, Portugal. Official language The official language will be English. No translation will be provided. Insurance The organisers bear no responsibility for untoward events in relation to the participation in the Conference. Participants are advised to take out their own personal and travel insurance coverage. Abstract book The abstract book is published as a supplement of The Breast (volume 22, supplement 3, November 2013) and contain abstracts of the invited lecturers and those submitted by the participants that have been accepted for oral or poster presentation or for publication only. The abstract deadline was 8 July Continuing Medical Education (CME) The Accreditation Council of Oncology in Europe (ACOE) and the European Accreditation Council for Continuing Medical Education (EACCME) have acknowledged the quality of the scientific programme and its educational value. ABC2 has been assigned 12 European Continuing Medical Education Credits (ECMEC). Through an agreement between the European Union of Medical Specialists and the Ameri- can Medical Association, physicians may convert EACCME credits to an equivalent number of AMA PRA Category 1 Credits. Information on the process to convert EACCME credit to AMA credit can be found at Furthermore, the conference has been accredited with 14 ESMO-MORA points Category 1. Dedicated website and certificates Participants (regular registrations and nurse registration) will be entitled to receive their attendance and CME certificates at the close of the Conference by completing the online evaluation questionnaire on the event dedicated website. The website address and your log-in details are indicated on the back of the name badge. Patient advocates and media representatives will receive the evaluation questionnaire with their registration materials. The certificate of attendance can be obtained at the registration desk at the closure of the Conference in return of the completed evaluation form. Internet access Free internet Wi-Fi access is available on Level 1 by entering the following log-in: Network name: ESO_ABC Password: ABC2Lisbon Social Media Twitter is available during the Conference - tweet, network and follow updates at #ABC2 7-9 NOVEMBER 2013, LISBON, PORTUGAL ABC2 7

8 Advanced Breast Cancer Second International Consensus Conference Lunches and coffee breaks Buffet points are organised in the exhibition area on Level 1. During the lunch break of Friday, 8 November participants are invited to visit the poster session in the same area. Press office Accredited journalists wearing a «Media representative» badge are invited to refer to the press office on Level 1. Third party media policy The policy applies to all activities related to the news media during or in connection with ABC2 and is posted at pagine-interne/third-party-media-policy.html. The aim is to ensure that information distributed to the journalists is accurate and is issued at the correct times, complying with any embargoes that may be in place. The policy applies to media events that are organised at the ABC2 venue and off-site, and all third parties are requested to adhere. Filming, audio-taping and photographs Please note that capturing contents of the sessions is prohibited. No smoking policy ABC2 is a tobacco-free event. All participants are kindly asked to respect the no-smoking policy. Badge All participants and exhibitors are kindly requested to wear their badges at all times. The badge is the only official evidence of registration and loss of badge causes loss of registration. Faculty and panel members Members of the faculty and of the panel are invited to refer to the speakers room located on Level 1. Registration information Admission to the sessions is granted to faculty members, participants and media representatives who hold a full registration. Furthermore, registration grants a copy of the programme book and of the abstracts book, coffee breaks, lunches and welcome cocktail as indicated in the programme. 8 ABC2 7-9 NOVEMBER 2013, LISBON, PORTUGAL Regular registration Early (by 19 August) Registration fee EUR 400 Club ESO Members EUR 300 ESMO Members EUR 300 Late (by 21 October) On-site (after 21 October) EUR 500 EUR 650 Cancellation of registration or replacement Replacement or refund of registration fees (less handling charges of EUR 100) was possible for notification to ESO by 1 October. Group registration The online group registration was available for groups of 5 or more participants. Please note that the group leader might have indicated that the on-site materials are to be collected by the individual participant, or by the group leader, or by a representative delegated for such task. The group leader was requested to provide the contact details of the person who will collect the group registration material onsite and such details were communicated to the participants on the confirmation of registration. Please note that on-site materials (badge, delegates bag, etc.) once collected may not be re-issued. Nurses and patient advocates Nurses and representatives of cancer patient advocacy non-profit organisations are eligible for a discounted registration fee: Nurses and Patient Advocates Early (by 19 August) Late (by 21 October) On-site (after 21 October) Registration fee EUR 200 EUR 250 EUR 350 To qualify for the discounted fee, the following documents are required: - Nurses: curriculum vitae with full contact details; - Patient advocates: curriculum vitae or resume indicating the experience in the field of patient advocacy, role within the organisation and the full contact details of the patient advocate organisation.

9 Media representatives The congress is open to representatives of print and electronic media. Registration is free of charge to journalists who are in possession of a valid, recognised press card. Freelance journalists must present a commissioning letter on headed paper from a recognised news organisation or publication. Representatives of advertising, marketing and public relations companies are not eligible for free media registration. For on-site registration, please present a copy of the press card or of the commissioning letter. Travel grants Travel grants were made available on a competitive basis to physicians from middleand low-income countries as defined by The World Bank, physicians under the age of 40, nurses and patient advocates who applied by the deadline of 8 July The successful submission of an abstract was not mandatory but it was considered in the selection process. Registration desks, opening hours Wednesday, 6 November 10:00-18:00 Thursday, 7 November 8:00-19:30 Friday, 8 November 8:30-20:30 Saturday, 9 November 8:30-13:00 Felipe Ades, BE Sushma Agrawal, IN Mahmoud Ahmed Alhussini, EG Akshay Anand, IN Adel Aref, AE Olexiy Aseyev, UA Natalia Botnariuc, MD Roswitha Britz, ES Diana Borlakova, BG Niya Chari, CA Karen S. Durham, US Sandy Finestone, US Julia Fishwick, IT Ahmed Gaballah, EG Désirée Hairwassers, NL Arin Hanson, US Alisher Kahharov, UZ Evangelia Kolypera, GR Ingrid Kössler, SE Elvisa Kozma, AL Behera Manoj Kumar, IN Matteo Lambertini, IT Maria Leadbeater, UK Gloria Lin, TW Roman Liubota, UA Iryna Liubota, UA Lori Marx-Rubiner, US Ginny Mason, US Ramona Matei, RO Anna Midlenko, KZ Ana Caterina Pinto, BE Lazar Popovic, RS Ann Potter, US Doris Price, US Sandra Radenkovic, RS Gabrielle Rocque, US Jean Rowe, US Charu Singh, IN Aggeliki Stefanaki, GR Richard Tancredi, IT Desiree Walker, US Mahfoudh Wijden, TN Exhibition, opening hours Thursday, 7 November Friday, 8 November Saturday, 9 November 9:00-19:30 9:00-20:00 9:00-13:00 «I am not the cancer» art installation During this year s conference Here & Now will be holding a thought-provoking art installation. «I am not the cancer» is an immersive audiovisual artwork that powerfully communicates the real-life experiences of patients living with advanced stage breast cancer through the patient voice. This innovative installation was created by two critically acclaimed artists, John Wynne and Tim Wainwright, to provide patients with a platform to share their thoughts, experiences and emotions in order to raise awareness of advanced breast cancer amongst both the breast cancer community and the wider public. The installation is part of the Here & Now campaign, an advanced breast cancer disease awareness initiative supported by Novartis Oncology. It will be hosted in Auditorium II on Thursday, 7 November and participants are invited to experience this initiative. Acknowledgements ESO wishes to express its appreciation and gratitude to the ABC2 Chairs for their support and vision in organizing this conference, all faculty members panelists and members of the Patient Advocacy Committee for their commitment and contribution to the programme, to The Breast and Cancer World for their partnership in this initiative. ESO is grateful to the The Breast Cancer Research Foundation, Susan G. Komen and Celgene Corporation for having provided travel grants to support the participation of: 7-9 NOVEMBER 2013, LISBON, PORTUGAL ABC2 9

10 Advanced Breast Cancer Second International Consensus Conference Official Carrier ESO is grateful to Star Alliance member airlines who supported the Conference as Official Carrier and offered discounted fares to the ABC2 participants. The participating airlines for ABC2 are: Adria Airways, Aegean Airlines, Air Canada, Air China, Air New Zealand, ANA, Asiana Airlines, Austrian Airlines, Avianca / TACA, Brussels Airlines, Copa Airlines, Croatia Airlines, EgyptAir, Ethiopian, EVA Air, LOT Polish Airlines, Lufthansa, Scandinavian Airlines, Singapore Airlines, South African Airways, SWISS International Air Lines, TAM Airlines, TAP Portugal, THAI, Shenzhen Airlines, Turkish Airlines, United, US Airways. Public transportation Public transportation is available from the hotels the congress centre: Distance Km/time Public transportation Altis Belém 3/15 A1 Pestana Palace 0,8/8 (walking distance) Jeronimos 8 2,5/15 A Sofitel Lisbon Liberdade 5/20 B Vila Gale Opera 0,3/3 (walking distance) Tivoli Lisboa 5/20 B Marques de Pombal 5/20 B Tivoli Jardim 5/20 B Sana Lisboa 6,5/25 B Fenix Lisboa 5/20 B Fenix Garden 5/20 B Hotel A1 Walk Tram 15 or bus meters from the hotel to tram/bus stop Belem Praça do Comercio (city centre) A Tram 15 or bus 28 Belem From hotel to venue: Bus 732 then tram 15 or bus 28 Praça do Comercio (city centre) B Avenida da Liberdade (1) Praça do Comercio (city centre) Avenida Fontes Pereira de Melo (2) 1: Tivoli Lisboa, Sofitel Lisbon Liberdade, Marques de Pombal, Tivoli Jardim, Fenix Lisboa, Fenix Garden 2: Sana Lisboa Belem Praça do Comercio (city centre) The stop at the congress centre «Rua Junqueira». 10 ABC2 7-9 NOVEMBER 2013, LISBON, PORTUGAL

11 BOOKING YOUR OWN CONFERENCE TRAVEL IS EASY AS ABC WITH THE GLOBAL ON LINE BOOKING TOOL FROM STAR ALLIANCE CON VENTION S PLUS No matter where you are travelling from, the Star Alliance network offers you a wide choice of flights to the ABC2 Advanced Breast Cancer Second Consensus Conference in Lisbon. And with over 21,900 flights a day to 1,329 destinations across 195 countries, our 28 member airlines extend the same choice to any future conferences you are planning to attend. You can also save money when you book your flights. Simply quote the Convention Code TP01S13 and you plus one travelling companion will receive a special discount. Better still, no matter which Star Alliance member airline s frequent flyer programme you belong to, you can earn and redeem miles across all 28 airlines. For more information, or to join the airline network that offers you more choice wherever your conferences take you, simply go to Information correct as of 06/ NOVEMBER 2013, LISBON, PORTUGAL ABC2 11

12 Advanced Breast Cancer Second International Consensus Conference Floor plan Room 5C Sala 3.C. Sala 5.C. copa Hall 5 PAVILHÃO 5 POSTERS AREA Patient Advocacy Sessions Auditorium I Serviços Auditorium III/IV 11 NANOSTRING TECHNOLOGIES Sala 5.A. CATERING Room 5A AREA Room 1.14 Sala 1.13 Foyer D 8 IGEA Room 1.09 Hall 4 6 WISEPRESS Hall 4 4 EISAI Room 1.13 Room 1.12 Sala PFIZER ONCOLOGY GSK Glaxo Smith Kline Room 1.06 secretaria Pfizer Oncology Meeting Suite Room 1.05 Room 1.11 Sala secretaria 2 NOVARTIS ONCOLOGY arrumos Auditorium Auditório II II 1A 1B EUROPA DONNA ESO Room 1.10 Sala 1.10 W.C. Bar SPEAKERS ROOM arrumos Room 1.04 PRESS ROOM CATERING AREA W.C. Room 1.03 Room 1.02 W.C. W.C. W.C. RESTAURANT restaurante First Floor 12 ABC2 7-9 NOVEMBER 2013, LISBON, PORTUGAL

13 Sponsors (as of 21 October 2013) ESO wishes to extend its appreciation for the following sponsors for having granted their participation and support to ABC2. Travel grants Participating companies, publisher and organisation 7-9 NOVEMBER 2013, LISBON, PORTUGAL ABC2 13

14 Advanced Breast Cancer Second International Consensus Conference Breast cancer patient advocacy programme Representatives of breast cancer patient advocacy groups are warmly invited to participate in ABC2 and actively contribute to the scientific programme and consensus sessions. Furthermore, in collaboration with several leading breast cancer patient advocacy groups worldwide, specific additional patient advocacy sessions have been scheduled. Breast Cancer Patient Advocacy Committee Coordinators: Fatima Cardoso Kathy Redmond Breast Cancer Unit, Champalimaud Cancer Center, Lisbon, PT Cancer World Magazine, Editor, Lugano, CH Dian «CJ» M. Corneliussen-James Shirley Mertz METAvivor Research and Support, Annapolis, US Metastatic Breast Cancer Network, Inverness, US Susan Knox Maxine Morand Europa Donna - The European Breast Cancer Coalition, Milan, IT Australian Breast Cancer Network Victoria, Camberwell, AU Amelia Pinto Leite Kimberly A. Sabelko Europa Donna, Portugal, Lisbon, PT Musa Mayer AdvancedBC.org, New York, US 14 ABC2 7-9 NOVEMBER 2013, LISBON, PORTUGAL Komen Foundation, Dallas, US

15 Breast cancer patient advocacy sessions Thursday, 7 November 9:00-10:30 Introductions and greatest challenges in meeting the needs of patients with advanced breast cancer (Chairs: S. Knox, IT - K.A. Sabelko, US - F. Cardoso, PT) 11:00-12:30 Challenges and guidelines in advanced breast cancer (Chairs: D.«CJ» M. Corneliussen-James, US and M. Morand, AU) 18:00-19:30 How can the ABC guidelines address global challenges? (Chairs: M. Mayer, US and S. Mertz, US) Friday, 8 November 18:30-20:00 Meet the expert session: Where will we be in the coming years? (Chair: K. Redmond, CH) (Panelists: L. Fallowfield, UK - L. Norton, US - A.H. Partridge, US - M.J. Piccart, BE) Saturday, 9 November 11:00-11:15 Report from ABC Patient Advocacy Committee D. «CJ» M. Corneliussen-James, US Registration Representatives of cancer patient advocacy non-profit organisations are eligible for a discounted registration fee. For further information, please refer to the paragraph Registration Nurses and Patient Advocates. Travel grants Travel grants were made available on a competitive basis. The application deadline is passed (8 July 2013). Acknowledgements ESO is grateful to Susan G. Komen for having provided an unrestricted grant to support the patient advocacy programme. 7-9 NOVEMBER 2013, LISBON, PORTUGAL ABC2 15

16 Advanced Breast Cancer Second International Consensus Conference ABC Award ESO is pleased to announce that, in recognition of his work on discovering fundamental, clinically-relevant biological and molecular mechanisms for metastases including site specificity, latency, self-seeding and the role of the microenvironment in colonization and drug resistance, the first ABC Award has been assigned to Joan Massagué. The Award Ceremony and Lecture are scheduled on Thursday, 7 November at 17:30. Chairs Fatima Cardoso Larry Norton Alberto Costa Eric P. Winer Breast Cancer Unit, Champalimaud Cancer Center, Lisbon, PT Breast Cancer Programs, Memorial Sloan-Kettering Cancer Centre, New York, US Scientific Director, European School of Oncology, Milan, IT and Bellinzona, CH Breast Oncology Center, Dana-Farber Cancer Institute, Boston, US Faculty members Matti S. Aapro Department of Oncology-Pathology, Karolinska Institute, Stockholm, SE Fabrice André Laura Biganzoli Department of Medical Oncology, Gustave Roussy Institute, Villejuif, FR Carlos H. Barrios Department of Medicine, PUCRS School of Medicine, Porto Allegre, BR 16 Jonas Bergh IMO Clinique De Genolier, Institut Multidisciplinaire d Oncologie, Genolier, CH ABC2 7-9 NOVEMBER 2013, LISBON, PORTUGAL Department of Medical Oncology, Sandro Pitigliani Oncology Centre, Prato, IT Kimberley L. Blackwell Breast Cancer Clinical Program, Duke Cancer Institute, Durham, US

17 Maria João Cardoso Breast Cancer Unit, Champalimaud Cancer Center, Lisbon, PT Musa Mayer AdvancedBC.org, New York, US Sofia D. Merajver Tanja Cufer University of Michigan Medical School and School of Public Health, Ann Arbor, US Nagi S. El Saghir Cancer Imaging, Paul Strickland Scanner Centre, Mount Vernon Cancer Centre, Northwood, UK Lesley Fallowfield Department of Medical Oncology, Oncology Institute of Southern Switzerland, Bellinzona, CH University Clinic of Respiratory & Allergic Diseases Golnik, Golnik, SL NK Basile Cancer Institute, American University of Beirut Medical Center, Beirut, LB Sussex Health Outcomes Research & Education in Cancer, Brighton & Sussex Medical School, University of Sussex, Brighton, UK Doris Fenech Breast Care Support Group, Europa Donna Malta, Mtarfa, MT Anwar R. Padhani Olivia Pagani Ann H. Partridge Department of Medical Oncology, Division of Women s Cancers, Dana-Farber Cancer Institute, Boston, US Frédérique Penault-Llorca Prudence A. Francis Jean Perrin Centre, Comprehensive Cancer Centre, Clermont Ferrand, FR Karen Gelmon Department of Medicine, Jules Bordet Institute, Brussels, BE Sharon H. Giordano Cancer World Magazine, Editor, Lugano, CH Joseph Gligorov Breast Oncology and Clinical Trials Education, UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, US Division of Cancer Medicine, Peter MacCallum Cancer Centre, Melbourne, AU Department of Medical Oncology, BC Cancer Agency, Vancouver, CA Department of Breast Medical Oncology, UT MD Anderson Cancer Centre, Houston, US Department of Medical Oncology, CancerEst APHP Tenon, University Paris VI, Paris, FR Nadia Harbeck Breast Center, University of Munich, Munich, DE Nehmat Houssami Screening and Test Evaluation Program (STEP), Sydney Medical School, University of Sydney, AU Clifford A. Hudis Breast and Imaging Center, Memorial SloanKettering Cancer Centre, New York, US Bella Kaufman Breast Cancer Unit, Sheba Medical Center, Tel Hashomer, Israel, IL Ian E. Krop Breast Oncology Center, Dana-Farber Cancer Institute, Boston, US Stella Kyriakides Europa Donna Cyprus, Nicosia, CY Nancy U. Lin Breast Oncology Center, Dana-Farber Cancer Institute, Boston, US Joan Massagué Cancer Biology and Genetics Program, Memorial Sloan-Kettering Cancer Center, New York, US Martine J. Piccart Kathy Redmond Hope S. Rugo Elzbieta Senkus-Konefka Department of Oncology and Radiotherapy, Medical University of Gdansk, Gdansk, PL George W. Sledge Division of Oncology, Stanford School of Medicine, Stanford, US Christoph Thomssen Clinic for Gynaecology, Martin-Luther-Universität, Klinikum Kröllwitz, Halle (Saale), DE Laura van t Veer Breast Oncology Program, University of California, San Francisco, US Daniel A. Vorobiof Sandton Oncology Centre, Johannesburg, ZA Conny Vrieling Department of Radiotherapy, Eaux Vives Oncology Centre, Geneva, CH Nicola West Nursing Division, Health Board, Cardiff and Vale University, Cardiff, UK Binghe Xu Department of Medical Oncology, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, CN 7-9 NOVEMBER 2013, LISBON, PORTUGAL ABC2 17

18 Advanced Breast Cancer Second International Consensus Conference ESO Advanced Breast Cancer Task Force Coordinators: Fatima Cardoso Eric P. Winer David A. Cameron Joseph Gligorov Breast Cancer Unit, Champalimaud Cancer Center, Lisbon, PT Edinburgh Breast Unit, Western General Hospital, Edinburgh, UK Department of Medical Oncology, CancerEst APHP Tenon, University Paris VI, Paris, FR Alberto Costa Stella Kyriakides Scientific Director, European School of Oncology, Milan, IT and Bellinzona, CH Nancy U. Lin Tanja Cufer University Clinic of Respiratory & Allergic Diseases Golnik, Golnik, SL Lesley Fallowfield Sussex Health Outcomes Research & Education in Cancer, Brighton & Sussex Medical School, University of Sussex, Brighton, UK Prudence A. Francis Division of Cancer Medicine, Peter MacCallum Cancer Centre, Melbourne, AU 18 Breast Oncology Center, Dana-Farber Cancer Institute, Boston, US ABC2 7-9 NOVEMBER 2013, LISBON, PORTUGAL Europa Donna Cyprus, Nicosia, CY Breast Oncology Center, Dana-Farber Cancer Institute, Boston, US Olivia Pagani Department of Medical Oncology, Oncology Institute of Southern Switzerland, Bellinzona, CH Elzbieta Senkus-Konefka Department of Oncology and Radiotherapy, Medical University of Gdansk, Gdansk, PL Christoph Thomssen Clinic for Gynaecology, Martin-Luther-Universität, Klinikum Kröllwitz, Halle (Saale), DE

19 ABC Conference and consensus guidelines The consensus guidelines for the management of advanced breast cancer that were developed at ABC1 (November 2011) are published in The Breast 21 (2012) The ABC1 guidelines are endorsed by SIS, the International Society of Senology ( The ABC2 guidelines will be developed by: ESO and ESMO and will be published simultaneously in Annals of Oncology and The Breast and are endorsed by: Furthermore, the ABC2 conference is held under the auspices of 7-9 NOVEMBER 2013, LISBON, PORTUGAL ABC2 19

20 EBCC 9 Advanced Breast Cancer Second International Consensus Conference European Breast Cancer Conference March 2014 GlasGow, scotland Fleurs et Fruits by J D Fergusson The Fergusson Gallery, Perth & Kinross Council, Scotland Conference Secretariat: 20 c/o ECCO the European CanCer Organisation Tel.: +32 (0) Fax: + 32 (0) Avenue E. Mounier, 83 B-1200 Brussels Belgium EBCC9@ecco-org.eu ABC2 7-9 NOVEMBER 2013, LISBON, PORTUGAL

21 Programme outline Wednesday, 6 November Thursday 7 November Friday 8 November Saturday 9 November 9:00-19:30 Exhibition 9:00-20:00 Exhibition 9:00-13:00 Exhibition 9:00-10:30 Breast cancer patient advocacy session 9:00-10:15 Inoperable locally advanced breast cancer (part I) 9:00-10:30 Consensus session (part I) 10:15-10:45 Coffee break 10:00 Registration opens 10:30-11:00 Coffee break 11:00-12:30 Breast cancer patient advocacy session 11:00-12:30 prime Oncology Satellite symposium supported by Celgene Corporation 12:30-13:30 Lunch 13:30-14:15 Opening session 14:15-16:15 Major advances since ABC1 10:45-11:40 Inoperable locally advanced breast cancer (part II) 10:30-11:00 Coffee break 11:00-11:15 Report from ABC Patient Advocacy Committee 11:40-12:30 Specific populations 11:15-12:45 Consensus session (part II) 12:30-13:00 Survivorship in advanced breast cancer: Panel discussion 12:45-13:00 Close 13:00-14:00 Lunch and poster session 14:00-15:40 Specific metastatic sites 15:40-16:00 Special session 16:00-16:30 Coffee break 16:15-16:35 Coffee break 16:35-17:30 Best abstract presentations 16:30-18:00 Supportive and palliative care issues 17:30-18:00 ABC Award and Lecture 18:00-19:30 Breast cancer patient advocacy session 18:00-18:30 Novartis Oncology Reception 18:00-19:30 GlaxoSmithKline Satellite symposium 18:30-20:00 Breast cancer patient advocacy - Meet the expert session 19:30 Welcome cocktail 18:30-20:00 Novartis Oncology Satellite symposium A/V Recording during the Conference is prohibited. 7-9 NOVEMBER 2013, LISBON, PORTUGAL ABC2 21

22 Advanced Breast Cancer Second International Consensus Conference Programme Wednesday, 6 November 10:00 Registration opens for individual participants and groups Thursday, 7 November 9:00-10:30 Audit. III/IV Breast cancer patient advocacy session: Introductions and greatest challenges in meeting the needs of patients with advanced breast cancer (Chairs: S. Knox, IT K.A. Sabelko, US F. Cardoso, PT) 10:30-11:00 Coffee break 11:00-12:30 Breast cancer patient advocacy session: Audit. III/IV Challenges and guidelines in advanced breast cancer (Chairs: D. «CJ» M. Corneliussen-James, US and M. Morand, AU) 11:00-12:30 prime Oncology Satellite symposium supported by Audit. I Celgene Corporation Innovation and differentiation: Key components of successful strategies for management of advanced breast cancer (Chair: A. Di Leo, IT) 11:00 Welcome and introduction (A. Di Leo, IT) 11:05 Contemporary chemotherapy for advanced breast cancer (ABC): Have we hit a glass ceiling? (A. Di Leo, IT) 11:15 Tailoring chemotherapy for selected breast cancer phenotypes: The scientific rationale (G. Curigliano, IT) 11:35 Audience questions and faculty comments 11:40 The current and potential future role of albumin-bound paclitaxel in ABC (J. Cortés, ES) 12:00 Audience questions and faculty comments 12:05 Taking what we ve learned from ABC into the neoadjuvant setting (M. Untch, DE) 12:25 Symposium pearls and concluding remarks (A. Di Leo, IT) Symposium faculty: Angelo Di Leo, Istituto Toscano Tumori, Hospital of Prato, Prato, IT Javier Cortés, Vall d Hebron University Hospital, Barcelona, ES Giuseppe Curigliano, European Institute of Oncology, Milan, IT Michael Untch, Helios Klinikum Berlin-Buch, Berlin, DE 12:30-13:30 Lunch A/V Recording during the Conference is prohibited. 22 ABC2 7-9 NOVEMBER 2013, LISBON, PORTUGAL

23 13:30-14:15 Opening session Audit. I (Chairs: F. Cardoso, PT and L. Norton, US) 13:30 Opening and introduction (F. Cardoso, PT) 13:40 Welcome to Lisbon (N. Cabral, President of the Port of Lisbon, PT) 13:50 Keynote lecture: A personal journal through advanced breast cancer [abstract IN2] (D. Fenech, MT) 14:15-16:15 Major advances since ABC1 Audit. I (Chair: E.P. Winer, US) 14:15 Advances in HER-positive advanced breast cancer (I.E. Krop, US) 14:45 Advances in TN advanced breast cancer [abstract IN4] (G.W. Sledge, US) 15:05 Advances in endocrine therapy and endocrine resistance [abstract IN5] (M.J. Piccart, BE) 15:25 Advances in cytotoxic and other targeted therapy [abstract IN6] (J. Gligorov, FR) 15:45 Advances in imaging [abstract IN7] (A.R. Padhani, UK) 16:00 Discussion 16:15-16:35 Coffee break 16:35-17:30 Best abstract presentations Audit. I (Chair: F. Cardoso, PT) 16:35 Nursing and patient advocacy: The challenges in optimising care in patients with advanced breast cancer: Results of an international survey [abstract OR26] (S. McCutcheon, UK) 16:50 Clinical issues: Overall survival and sequential treatment of patients with metastatic breast cancer treated by German office-based medical oncologists - Outcome data from the TMK Registry Group [abstract OR39] (N. Marschner, DE) 17:05 Clinical issues: Meta-analysis resolves the role of combination versus sequential chemotherapy for metastatic breast cancer [abstract OR130] (R. Dear, AU) 17:20 Basic and translational research: What we know about primary metastatic breast cancer: Pathological characteristics and outcome over a 10-year period [abstract OR112] (J. Barinoff, DE) 17:30-18:00 ABC Award and Lecture: Deconstructing metastasis [abstract IN1] Audit. I (Chair: L. Norton, US) (Awardee: J. Massagué, US) A/V Recording during the Conference is prohibited. 7-9 NOVEMBER 2013, LISBON, PORTUGAL ABC2 23

24 Advanced Breast Cancer Second International Consensus Conference 18:00-19:30 Breast cancer patient advocacy session: How can the ABC guidelines Audit. III/IV address global challenges? (Chairs: M. Mayer, US and S. Mertz, US) 18:00-19:30 GlaxoSmithKline Satellite symposium Audit. I Integrating novel combinations into the sequencing of HER2-positive metastatic breast cancer treatment 18:00 Introduction 18:10 Progression beyond trastuzumab: Where are we now? (V. Guarneri, IT) 18:25 Biologic rationale and clinical evidence for using two anti-her2 therapies with different modes of action (W. Janni, DE) 18:45 How to define the right sequence in the HER2-positive metastatic breast cancer scenario? Interactive case studies (E. Ciruelos, ES) 19:20 Discussion and closing remarks Symposium faculty: Valentina Guarneri, University of Padova, IRCSS, Padova, IT Wolfgang Janni, University Hospital Ulm, Ulm, DE Eva Ciruelos, Hospital Universitario 12 de Octubre, Madrid, ES 19:30- Welcome cocktail Friday, 8 November 9:00-10:15 Inoperable locally advanced breast cancer (part I) Audit. I (Chairs: F. Cardoso, PT and E.P. Winer, US) 9:00 The biology of locally advanced breast cancer: Inflammatory and non-inflammatory [abstract IN8] (F. Penault-Llorca, FR) 9:20 Epidemiology and geographic differences [abstract IN9] (E. Senkus-Konefka, PL) 9:40 Systemic therapy: Optimal strategies and therapies [abstract IN10] (N. Harbeck, DE) 10:05 Discussion 10:15-10:45 Coffee break 10:45-11:40 Inoperable locally advanced breast cancer (part II) Audit. I (Chairs: F. Cardoso, PT and E.P. Winer, US) 10:45 Radiotherapy: Best timing and techniques [abstract IN11] (C. Vrieling, CH) 11:05 Surgery: Challenges and opportunities [abstract IN12] (M. J. Cardoso, PT) 11:25 Discussion A/V Recording during the Conference is prohibited. 24 ABC2 7-9 NOVEMBER 2013, LISBON, PORTUGAL

25 11:40-12:30 Specific populations Audit. I (Chair: K. Gelmon, CA) 11:40 Metastatic male breast cancer [abstract IN13] (S.H. Giordano, US) 12:00 BRCA-related advanced breast cancer [abstract IN14] (P.A. Francis, AU) 12:20 Discussion 12:30-13:00 Audit. I Survivorship in advanced breast cancer Panel discussion (Chair: K. Redmond, CH) (Panelists: L. Fallowfield, UK S. Kyriakides, CY - M. Mayer, US - O. Pagani, CH - Ann H. Partridge, US N. West, UK) 13:00-14:00 Lunch and poster session (please see the list of poster presentations on pages 28-31) 14:00-15:40 Specific metastatic sites Audit. I (Chairs: F. André, FR and H.S. Rugo, US) 14:00 Multidisciplinary approach to liver metastases [abstract IN15] (C.H. Barrios, BR) 14:15 Update on brain metastases management (N.U. Lin, US) 14:30 Optimal management of pleural effusions (B. Kaufman, IL) 14:45 Chest wall recurrences and cutaneous metastases [abstract IN18] (K.L. Blackwell, US) 15:05 Can specific sites of metastases be predicted and prevented? [abstract IN19] (L. van t Veer, US) 15:25 Discussion 15:40-16:00 Special session Audit. I (Chair: L. Norton, US) 15:40 The role of mathematical and computer modeling for metastases research [abstract IN20] (S.D. Merajver, US) 15:55 Discussion 16:00-16:30 Coffee break 16:30-18:00 Supportive and palliative care issues Audit. I (Chairs: M.S. Aapro, CH and G.W. Sledge, US) 16:30 Optimal pain control [abstract IN21] (L. Biganzoli, IT) 16:50 Optimal management of nausea and vomiting [abstract IN22] (J. Bergh, SE) 17:05 Psycological support: When and how? [abstract IN23] (L. Fallowfield, UK) 17:20 Patient perspective on symptom control [abstract IN24] (M. Mayer, US) 17:35 Disparities in access to supportive/palliative specialised care [abstract IN25] (Nagi S. El Saghir, LB) 17:50 Discussion A/V Recording during the Conference is prohibited. 7-9 NOVEMBER 2013, LISBON, PORTUGAL ABC2 25

26 Advanced Breast Cancer Second International Consensus Conference 18:00-18:30 Novartis Oncology Reception Foyer 18:30-20:00 Audit. III/IV Breast cancer patient advocacy Meet the expert session Where will we be in the coming years? (Chair: K. Redmond, CH) (Panelists: L. Fallowfield UK, L. Norton, US A.H. Partridge, US M. J. Piccart, BE) 18:30-20:00 Novartis Oncology Satellite symposium Audit. I Advanced breast cancer cases - Packing for the journey (Chair: W. Janni, DE) 18:30 Welcome aboard (W. Janni, DE) 18:40 Understanding the landscape of ABC (W. Janni, DE) 18:50 Mapping out treatment options in HR+/HER2- ABC (G. Jerusalem, BE) 19:10 Maintaining quality of life and staying on course with therapy in HER+/HER2- ABC (M. Mano, BR) 19:30 Overall Q&A (Panel) 19:45 Conclusions and overview of the journeys ahead (W. Janni, DE) Symposium faculty: Wolfgang Janni, University of Ulm, Ulm, DE Guy Jerusalem, Centre Hospitalier Universitaire, Liege, BE Max Mano, University of Sao Paulo, Sao Paulo, BR Saturday, 9 November :00-10:30 Consensus session (part I) Audit. I (ABC2 Chairs) 10:30-11:00 Coffee break 11:00-11:15 Report from ABC Patient Advocacy Committee Audit. I (D. «CJ» M. Corneliussen-James, US) 11:15-12:45 Consensus session (part II) Audit. I (ABC2 Chairs) 12:45-13:00 Close Audit. I A/V Recording during the Conference is prohibited. 26 ABC2 7-9 NOVEMBER 2013, LISBON, PORTUGAL

27 Consensus Panellists Matti S. Aapro, CH Ian E. Krop, US Fabrice André, FR Stella Kyriakides, CY Carlos H. Barrios, BR Nancy U. Lin, US Jonas Bergh, SE Musa Mayer, US Laura Biganzoli, IT Sofia D. Merjaver, US Kimberley L. Blackwell, US Larry Norton, US Fatima Cardoso, PT Anwar R. Padhani, UK Maria J. Cardoso, PT Olivia Pagani, CH Alberto Costa, CH/IT Ann H. Partridge, US Tanja Cufer, SL Frédérique Penault-Llorca, FR Nagi S. El Saghir, LB Martine J. Piccart, BE Lesley Fallowfield, UK Hope S. Rugo, US Doris Fenech, MT Elzbieta Senkus-Konefka, PL Prudence A. Francis, AU George W. Sledge, US Karen Gelmon, CA Christoph Thomssen, DE Sharon H. Giordano, US Laura van t Veer, US Joseph Gligorov, FR Daniel A. Vorobiof, ZA Nadia Harbeck, DE Conny Vrieling, CH Nehmat Houssami, AU Nicola West, UK Clifford A. Hudis, US Eric P. Winer, US Bella Kaufman, IL Binghe Xu, CN 7-9 NOVEMBER 2013, LISBON, PORTUGAL ABC2 27

28 Advanced Breast Cancer Second International Consensus Conference Poster session Posters can be viewed from Thursday, 7 November, 11:00 hours till Saturday, 9 November at 13:00 hours. On Friday, 8 November, during the lunch break from 13:00 to 14:00 hours, the poster session will be held with the visit of the designated members of the faculty. BP: Best poster presentation; PO: Poster presentation 28 BP27 Count us, know us, join us global survey: Looking at quality of life issues affecting advanced breast cancer patients worldwide and the role of their caregivers. Shirley Mertz, US BP40 Multicenter phase II study of apatinib, a novel inhibitor of VEGFR, in heavily pretreated patients with metastatic triple negative breast cancer. Biyun Wang, CN BP41 Effectiveness of taxane- or anthracylin-based compared to taxane- and anthracyline-free firstline treatments of patients with metastatic breast cancer treated by German office-based medical oncologists. Data from the TMK Registry Group. Norbert Marschner, DE PO28 Defining the unique and persistent needs of young women in the U.S. living with metastatic breast cancer through a multi-phased needs assessment. Arin Hanson,US PO29 Metastatic breast cancer in Canada: The lived experience of patients and caregivers presented by the Canadian Breast Cancer Network. Niya Chari, CA PO30 Surveying young women with metastatic breast cancer to create interventions with impact. Jean Rowe, US PO31 Palliative care and metastatic breast cancer: Involvement of a community palliative care specialist nursing team. Maria Leadbeater, UK PO32 How do women with metastatic breast cancer view palliative care? A qualitative study using a grounded theory approach to enable the views of women to be sought. Tara Beaumont, UK PO33 Susan G. Komen investment in metastatic breast cancer (MBC). Karen S. Durham, US PO34 Funding priorities for cancer research in USA. An advocacy initiative to gauge perception of metastatic breast cancer research and funding amongst cancer researchers in the USA. Arti Santhanam, US PO35 YSC research think tank: Determining research priorities for young women with metastatic breast cancer. Jean Rowe, US PO36 Inflammatory breast cancer research foundation: Patient information and support, research collaboration and IBC biobank. Ginny Mason, US PO37 Advanced breast cancer: Living in the moment. Never give up; even toward the end of life, a tiny flame of candle can give still warmth. Gloria Wei-Chieh Lin, TW PO38 A healthy walk with sticks in the midst of nature. Julia Lynn Fishwick, IT PO42 Surgical management of primary tumor in newly diagnosed metastatic breast cancer patients A systematic review of the literature. Felipe Ades, BE PO43 Role of breast surgery on survival of patients with primary advanced breast cancer. Iryna Liubota, UA ABC2 7-9 NOVEMBER 2013, LISBON, PORTUGAL

29 PO44 Audit of the investigation and management of loco-regional breast cancer recurrences in a UK district general hospital. Alice Elvy, UK PO45 Surgical resection of the primary tumor may improve survival in patients with stage IV breast cancer. Kenji Higaki, JP PO46 Pulmonary resection for lung oligometastatic disease in metastatic breast cancer. Mariko Kochi, JP PO47 Using local flaps for coverage of defects after excision of advanced malignant breast lesions. Mahmoud Alhussini, EG PO52 Are postchemotherapy target volume adequate as boost volume for conserved breast in locally advanced breast cancer? Sushma Agrawal, IN PO53 Clinical target volume in conserved breast in locally advanced breast cancer. Sushma Agrawal, IN PO54 Activity and duration of chemotherapy in different biologic subtypes in metastatic breast cancer patients. Matteo Lambertini, IT PO55 The combination chemotherapy of gemcitabine and vinorelbine in HER2-negative patients with taxane-pretreated metastatic breast cancer: A phase II study of Kinki Multidisciplinary Breast Oncology Group (KMBOG) 1015 (UMIN ). Jun Yamamura, JP PO56 Triple negative and hormone-negative/her2-positive breast cancer: Which the worst for women with meta static disease? A mono-institutional retrospective analysis on 460 patients. Raffaella Palumbo, IT PO57 Comparison of docetaxel plus trastuzumab and vinorelbine plus trastuzumab as first-line therapy of anthracycline pre-treated metastatic or locally advanced human epidermal growth factor receptor 2-positive breast cancer (a sub-group analysis of the HERNATA study). Michael Andersson, DK PO58 Efficacy and safety of first-line everolimus plus letrozole in ER+ HER2- metastatic breast cancer: A multi-center, open-label, phase 2 trial BOLERO-4. Francois Ringeisen, CH PO59 Efficacy and safety of everolimus plus exemestane combination therapy versus monotherapy with everolimus or capecitabine in HR+, HER2- breast cancer: A multi-center, open-label, phase 2 trial BOLERO-6. Guy Jerusalem, BE PO60 Good results of intensive systemic treatment of patients with HER2-positive breast cancer with brain metastases. Anna Niwinska, PL PO61 Oral vinorelbine and capecitabine: An acceptable and effective combination chemotherapy for early metastatic breast cancer (MBC). Martin Hogg, UK PO62 Different patterns of treatment with albumin-bounded paclitaxel (nab-paclitaxel) for targeted chemotherapy in metastatic breast cancer: A multicenter Italian experience on 125 women. Raffaella Palumbo, IT PO63 Impact of treatment with lapatinib in systemic advanced carcinoma breast. Manoj Behera, IN PO64 Comparison of fulvestrant versus tamoxifen for treatment advanced breast cancer in postmenopausal women. Charu Singh, IN PO65 The comparison of methotrexate and liposomal cytarabine in the intrathecal treatment of patients with breast cancer and leptomeningeal metastasis. Anna Niwinska, PL PO66 All-oral combination chemotherapy with capecitabine and cyclophosphamide is effective and safe for metastatic breast cancer patients. Masahiko Suzuki, JP PO67 Clinical benefit of ethinylestradiol as a salvage endocrine therapy for the heavily pretreatedmetastatic breast cancer. Hirotaka Iwase, JP PO68 Treatment with eribulin (Halaven) in heavily pre-treated patients with metastatic breast cancer. M Lynge, DK 7-9 NOVEMBER 2013, LISBON, PORTUGAL ABC2 29

30 Advanced Breast Cancer Second International Consensus Conference PO69 Eribulin in practice, review of 70 cases from single institute and comparison with Japan phase 2 study. Junichiro Watanabe, JP PO70 Clinical benefit of fulvestrant in postmenopausal women with advanced breast cancer according to prior therapy. Carmine De Angelis, IT PO71 Safety profile and tolerability of trabectedin and indole-3-carbinol combination in refractory advanced breast cancer. Preliminary results of phase 1 clinical study. Richard Tancredi, IT PO72 Clinical safety and efficacy of long-term use of zoledronic acid hydrate for breast cancer bone metastasis. Tomofumi Osako, JP PO74 New trends in the survival of patients with locally advanced breast cancer. Nagi El Saghir, LB PO75 Is the breast cancer graded prognostic assessment tool valid in Scottish patients with secondary brain metastases? Lucy Wells, UK PO76 Clinicopathological features and survival after recurrence in breast cancer patients with early and late recurrence after adjuvant chemotherapy. Byung Ho Son, KR PO77 Disease characteristics in HER2-positive metastatic breast cancer patients achieving complete remission during trastuzumab therapy. Snezana Susnjar, RS PO79 Prolonged survival after breast cancer brain metastases (BCBM): Who has a chance? Zorica Tomasevic, RS PO80 Neutropenia may be a prediction marker of therapeutic effect in metastasis breast cancer patients treated with eribulin. Yuri Yoshimura, JP PO81 Electrochemotherapy of skin breast cancer metastases. Rodrigo Oom, PT PO82 Clinicopathological analysis of the risk factors of disease progression in HER2 positive breast cancer patients. Joanna Huszno, PL PO83 Assessing acute thrombophlebitis due to intravenous vinorelbine chemotherapy in metastatic breast cancer patients at the University Hospital of North Staffordshire (UHNS). Shahid Gilani, UK PO84 Visualizing treatment and outcomes in metastatic breast cancer. Gabrielle Rocque, USA PO85 Characteristics and prognosis of hormone receptor positive and HER2 negative recurrent breast cancer patients receiving postoperative aromatase inhibitor. Ishida Mayumi, JP PO86 Predictive markers of clinical outcome for breast cancer patients treated in phase 1 trials: National Cancer Center Hospital experience. Aiko Nagayama, JP PO87 Prognostic factors predicting survival after first recurrence in patients with metastatic breast cancer. Masahiro Hikichi, JP PO88 Locally advanced breast cancer in Albanian women. Elvisa Kozma, AL PO89 Advanced breast cancer in Ethiopia: Characteristics and follow-up of 148 patients with stage 4 disease. Christoph Thomssen, DE PO100 Long-term bone management by bisphosphonate in metastatic breast cancer patients. Junichiro Watanabe, JP PO101 Management of peripheral neuropathy induced by nab-ptx therapy for breast cancer. Tsuyoshi Ohno, JP PO102 Paclitaxel induced CIPN - Can it be controlled? Rakesh Roy, IN PO103 Improving palliative care in clinical routine: Inhouse training of palliative medicine and its effects and evaluation in a breast and gynecological center of a CCC. Rachel Wuerstlein, DE PO104 Patients with discordance in estrogen receptor between primary breast cancers and recurrent tumors have poor outcomes. Sayuri Akiyoshi, JP PO105 Changes in activities and participation resulting in disability associated with metastatic breast cancer. Ann Marie Potter, US 30 ABC2 7-9 NOVEMBER 2013, LISBON, PORTUGAL

31 PO106 Extended stability studies of anticancer drugs can improve the access of patients to innovative treatments. Example of eribulin in advanced/metastatic breast cancer. Alain Astier, FR PO107 Study of health resource utilisation in patients with HER2-positive metastatic breast cancer (SHRUB) A prospective data collection study in progress. Jacinta Abraham, UK PO108 Safety and efficacy of brachium implanted central venous access port for metastatic breast cancer patients. Tomomi Fujisawa, JP PO109 Use of whole body MRI in breast cancer: A retrospective analysis of WB-MRIs within a 12 month period in a cancer centre. Bhavi Trivedi, UK PO113 Discordance of hormone receptor and HER2 status between primary and recurrent breast cancer: New treatment strategy for predicting outcome of patients with breast cancer. Sho Shiino, JP PO115 Expression of androgen receptor in locally advanced breast cancer with special relation to various molecular phenotypes, clinicopathological factors and response to anterior chemotherapy in Indian women. Akshay Anand, IN PO116 Discordance in triple-receptor status between primary and recurrent breast cancer. Akiko Matsumoto, JP PO117 Impairment of IFN gamma production and NK cell cytotoxicity of advanced breast cancer patients. Sandra Radenkovic, RS PO118 Significance of gene amplifications on relapse-free survival (RFS) and overall survival (OS) in metastatic breast cancer. Natasa Todorovic-Rakovic, RS PO119 Immune reactivity at patient with breast cancer associated with type 2 diabetes mellitus. Natalia Botnariuc, MD PO120 Factors, affecting changes in immunohistochemistry phenotype of breast cancer. Olexiy Aseyev, UA PO121 Increased relapse ratios in node-positive breast cancer patients with methylenetetrahydrofolate reductase polymorphism. Hakan Buyukhatipoglu, TR PO122 Predictive factor of late recurrences in breast cancer patients. Hiromitsu Jinno, JP PO123 Thymidylate synthase expression as a significant predictive factor in metastatic breast cancer. Hirohito Seki, JP PO124 The influence of HER2 status on localization of the first relapse site in young HR-positive breast cancer patients treated with adjuvant ovarian ablation. Marijana Milovic-Kovacevic, RS PO125 Influence of HER2 status on metastatic pattern in postmenopausal hormone receptor positive breast cancer patients treated with adjuvant tamoxifen only. Ivana Bozovic Spasojevic, RS 7-9 NOVEMBER 2013, LISBON, PORTUGAL ABC2 31

32 Advanced Breast Cancer Second International Consensus Conference Abstract presenters Jacinta Abraham, Velindre Cancer Centre, Cardiff, UK Felipe Ades, Institut Jules Bordet, Department of Medical Oncology, Brussels, BE Sushma Agrawal, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Department of Radiotherapy, Lucknow, IN Sayuri Akiyoshi, National Kyushu Cancer Center, Department of Breast Oncology, Fukuoka, JP Mahmoud Alhussini, Alexandria Faculty of Medicine, Department of Surgery, Alexandria, EG Akshay Anand, KG Medical University Lucknow, Department of Surgery, Lucknow, IN Michael Andersson, Copenhagen University Hospital Rigshospitalet, Copenhagen, DK Olexiy Aseyev, Dnepropetrovsk State Medical Academy, Department of Oncology and Medical Radiology, Dnepropetrovsk, UA Alain Astier, GH Henri Mondor, Department of Pharmacy, Créteil, FR Jana Barinoff, Kliniken Essen Mitte, Klinik Für Gynäkologische Onkologie, Essen, DE Tara Beaumont, Breast Cancer Care, Clinical Department, Sheffield, UK Manoj Behera, All India Institute Of Medical Sciences (AIIMS), Department of Radiation Onclogy, New Delhi, IN Natalia Botnariuc, Oncologic Institute, Mammology Department, Chisinau, MD Ivana Bozovic Spasojevic, Institute for Oncology and Radiology of Serbia, Department of Medical Oncology, Belgrade, RS Hakan Buyukhatipoglu, Gaziantep University Oncology Hospital, Gaziantep, TR Niya Chari, University of Queensland, University of Toronto, Ottawa, CN Dian «CJ» M. Corneliussen-James, METAvivor Research and Support, Annapolis, US Carmine De Angelis, University of Naples «Federico II» Medical Oncology Department, Naples, IT Rachel Dear, University of Sydney, Sydney, AU Karen S. Durham, Susan G. Komen, Advocates In Science, Lindale, US Nagi El Saghir, American University of Beirut Medical Center, Breast Center of Excellence, Naef K. Basile Cancer Institute, Beirut, LB Alice Elvy, University Of Birmingham, Department of Medicine, Birmingham, UK Julia Lynn Fishwick, Associazione Salute Donna Onlus, Milan, IT Tomomi Fujisawa, Gunma Prefectural Cancer Center, Department of Breast Oncology, Takabayashi-Nishi Cho, JP Shahid Gilani, University Hospital of North Staffordshire, Cancer Centre, Stoke On Trent, UK 32 ABC2 7-9 NOVEMBER 2013, LISBON, PORTUGAL

33 Arin Hanson, Living Beyond Breast Cancer, Haverford, US Kenji Higaki, Hiroshima City Hospital, Breast Surgery Department, Hiroshima, JP Masahiro Hikichi, Fujita Health University Department of Breast Surgery, Toyoake JP Martin Hogg, Royal Preston Hospital, Preston, UK Joanna Huszno, Maria Skłodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Clinical and Experimental Oncology Department, Gliwice, PL Hirotaka Iwase, Kumamoto University, Breast and Endocrine Surgery Department, Kummamoto, JP Guy Jerusalem, Sart-Tilman University Hospital, Liège, BE Hiromitsu Jinno, Keio University School of Medicine, Department of Surgery, Shinjuku, JP Mariko Kochi, Hiroshima City Hospital, Department of Breast Surgery, Hiroshima, JP Elvisa Kozma, University Hospital Mother Theresa, Oncology Department, Tirana, AL Matteo Lambertini, IRCCS AOU San Martino-IST, Department of Medical Oncology A, Genoa, IT Maria Leadbeater, Ashgate Hospice, Macmillan Specialist Palliative Care Nursing Team, Chesterfield, UK Iryna Liubota, National Medical University named After O.O. Bogomolets, Municipal Clinical Oncological Centre, Surgical Oncology, Kiev, UA Sven T. Langkjer, Aarhus University Hospital, Aarhus, DK Maja Lynge, Aarhus University Hospital, Department of Oncology, Odense S, Højby, DK Norbert Marschner, Praxis für Interdisziplinäre Onkologie und Hämatologie, Freiburg i. Br., DE Ginny Mason, Inflammatory Breast Cancer Research Foundation, Bainbridge Island, West Lafayette, US Akiko Matsumoto, Keio University School of Medicine, Surgery Department, Tokyo, JP Ishida Mayumi, National Kyushu Cancer Center, Department of Breast Oncology, Fukuoka, JP Susan McCutcheon, Eisai Europe Ltd, Eisai Value Maximization Systems, Hatfield, UK Shirley Mertz, Metastatic Breast Cancer Network, New York, US Marijana Milovic-Kovacevic, Institute for Oncology and Radiology of Serbia, Medical Oncology Department, Belgrade, RS Aiko Nagayama, National Cancer Center, Department of Breast and Medical Oncology, Tokyo, JP Anna Niwinska, The Maria Sklodowska-Curie Memorial Cancer Center and Institute Of Oncology, Department of Breast Cancer and Reconstructive Surgery, Warsaw, PL Tsuyoshi Ohno, Nagasaki Municipal Hospital, Department of Surgery, Nagasaki, JP Rodrigo Oom, Instituto Português de Oncologia de Lisboa, Department of General Surgery, Lisbon, PT Tomofumi Osako, Kumamoto City Hospital, Breast and Endocrine Surgery Department, Kumamoto, JP Raffaella Palumbo, Fondazione Maugeri-IRCCS, Operative Unit of Departmental Medical Oncology, Pavia, IT Ann Marie Potter, Elizabethtown College, Occupational Therapy Department, Elizabethtown, US Sandra Radenkovic, Institute of Oncology and Radiology of Serbia, Department of Radiation Oncology, Belgrade, RS Francois Ringeisen, Novartis Pharma AG, Basel, CH 7-9 NOVEMBER 2013, LISBON, PORTUGAL ABC2 33

34 Advanced Breast Cancer Second International Consensus Conference Gabrielle Rocque, University of Wisconsin, Department of Hematology/Oncology, Mountain Brook, US Jean Rowe, Young Survival Coalition, Programs Department, New York, US Rakesh Roy, Sarod Gupta Cancer Centre & Research Institute, Department of Medical Oncology, Kolkata, IN Hirohito Seki, Kitasato Institute Hospital, Breast Center, Surgery Department, Tokyo, JP Sho Shiino, National Cancer Center Hospital, Tokyo, Japan Charu Singh, S.M.S. Medical College and Hospital, Department of Radiotherapy and Clinical Oncology, Jaipur, IN Byung Ho Son, Asan Medical Center, Department of Surgery, Seoul, KR Snezana Susnjar, Institute for Oncology and Radiology of Serbia, Medical Oncology Department, Belgrade, RS Masahiko Suzuki, Kitamurayama Hospital, Breast Center, Higashine, JP Richard Tancredi, IRCCS Foundation Salvatore Maugeri, Medical Oncology Unit, Pavia, IT Christoph Thomssen, Martin Luther University Halle an der Saale, Department of Gynaecology, Halle an der Saale, DE Zorica Tomasevic, Institute for Oncology and Radiology, Daily Chemotherapy Hospital, Belgrade, RS Bhavi Trivedi, Musgrove Park Hospital, Department of Oncology, Somerset, UK Biyun Wang, Fudan University, Shanghai Cancer Center, Department of Medical Oncology, Shanghai, CN Junichiro Watanabe, Shizuoka Cancer Centre, Breast Oncology Department, Shizuoka, JP Gloria Wei-Chieh Lin, Taiwan Breast Cancer Alliance, Taipei, TW Lucy Wells, NHS Lothian, Department Of Oncology, Edinburgh, UK Rachel Wuerstlein, University Hosiptal Munich, Breast Center, Munich, DE Jun Yamamura, Sakai City Hospital Surgery, Breast Oncology Department, Sakai, JP Yuri Yoshimura, Hiroshima City Hospital, Breast Surgery Department, Hiroshima, JP 34 ABC2 7-9 NOVEMBER 2013, LISBON, PORTUGAL

35 Disclosure of conflict of interest Faculty members have been asked to disclose any potential conflict of interest in relation to their participation in the conference. Potential conflict of interest are considered any of the following: Any financial interest in or arrangement with a company whose products or services are discussed in the lecture or that might be considered as part of the consensus process. Any financial interest in or arrangement with a competing company. Any other financial relationship, direct or indirect, or other situations that might raise the question of bias in the work presented or in the participation in the consensus process, including pertinent commercial or other sources of funding for the speaker or panellist or for the associated department or organisation, personal relationships or direct academic competition. Chairs, faculty and panel members Matti S. Aapro: Amgen, BMS, Celgene, GSK, Helsinn, JnJ, Novartis, Merck, Merck Serono, Pfizer, Pierre Fabre, Roche, Sandoz, Teva, Vifor: speakers bureau, research and travel support. Pfizer: consultant or advisory board member and travel support. Maria João Cardoso: No significant relationships. Dian «CJ» M. Corneliussen-James: No significant relationships. Fabrice André: AstraZeneca and Novartis: speakers bureau, consultant or advisory board member, research support. Alberto Costa: Dune Medical: consultant or advisory board member. Carlos H. Barrios: Genentech, Amgen, Glaxo Smithkline, Novartis Biociencias S.A., Pfizer, Roche Produtos Quimicos e Farmaceuticos S.A.: PI of clinical trials. Nagi S. El Saghir: GSK: research support. Roche: research and travel support for conferences and conference honoraria. Novartis: travel support to conferences and conference honoraria. Sanofi: research and travel support. Jonas Bergh: No significant relationships. Laura Biganzoli: Celgene: research and travel support. Roche: travel support. Kimberley L. Blackwell: Celgene Corporation and Gentech BioOncology/Roche: research support. Genomic Health: speakers bureau. Novartis Pharmaceuticals and Sandoz: consultant or advisory board member. Fatima Cardoso: AstraZeneca, Eisai, GE Oncology, Genentech, Merck-Sharp, Merus BV, Novartis, Roche: consultant or advisory board member. Celgene and GSK: speakers bureau and consultant or advisory board member. Tanja Cufer: No significant relationships. Lesley Fallowfield: Amgen: speakers bureau and consultant or advisory board member. Boehringer-Ingelheim: research support. Roche: consultant or advisory board member and research support. GSK: consultant or advisory board member. Doris Fenech: No significant relationships. Prudence A. Francis: Amgen: travel support. Karen Gelmon: No significant relationships. Sharon H. Giordano: No significant relationships. 7-9 NOVEMBER 2013, LISBON, PORTUGAL ABC2 35

36 Advanced Breast Cancer Second International Consensus Conference Joseph Gligorov: Roche: speakers bureau, consultant or advisory board member, research and travel support. Eisai: consultant or advisory board member and research support. Genomic Health: speakers bureau and research support. Novartis: consultant or advisory board member. GlaxoSmithKline, Novartis, Roche-Genentech and Sanofi-Aventis: grant support. Bayer, Roche-Genentech, Amgen, Sanofi-Aventis, AstraZeneca, Novartis: honoraria. Nadia Harbeck: Celgene, Novartis, Roche: speakers bureau and consultant or advisory board member. GSK: consultant or advisory board member. Kathy Redmond: Novartis Oncology, Amgen and GSK: consultant or advisory board member. Nehmat Houssami: No significant relationships. Clifford A. Hudis: Merck: research support ended in Bella Kaufman: No significant relationships. Susan Knox: No significant relationships. Ian E. Krop: Genentech: research support. Stella Kyriakides: No significant relationships. Nancy U. Lin: GlaxoSmithKline, Genentech and Geron: research support. Joan Massagué: Scholar Rock Inc.: consultant or advisory board member. Musa Mayer: No significant relationships. Sofia D. Merajver: No significant relationships. Shirley Mertz: No significant relationships. Maxine Morand: No significant relationships. Larry Norton: No significant relationships. Anwar R. Padhani: Siemens HealthCare and Janssen Pharmaceutical Company: speakers bureau. Olivia Pagani No significant relationships. Ann H. Partridge: No significant relationships. Frédérique Penault-Llorca: Roche: consultant or advisory board member and research support. Martine J. Piccart: PharmaMar: board member. Sanofi-Aventis, Amgen, RocheGenentech, Bayer, AstraZeneca, Pfizer, Verastem, MSD, Synthon, Invivis, Astellas, Symphogen: consultant. Pfizer, Amgen, Bayer, Boehringer-Ingelheim, Bristol Myers- Squibb, 36 ABC2 7-9 NOVEMBER 2013, LISBON, PORTUGAL Amelia Pinto Leite: No significant relationships. Hope S. Rugo: Novartis and Genomic Health: travel support. Plexxikon, Merck, Celsion, Eisai, GSK, Amgen: research support to University of California, San Francisco (UCSF) only. Kimberly A. Sabelko: No significant relationships. Elzbieta Senkus-Konefka: Roche: speakers bureau and travel support. Amgen: travel support. GlaxoSmithKline and AstraZeneca: speakers bureau and consultant or advisory board member. George W. Sledge: Symphogen and Genomic Health: consultant or advisory board member. Seattle Genetics: speakers bureau. Christoph Thomssen: Roche Pharma AG, Amgen GmbH, Pfizer Pharma GmbH and Celgene GmbH, Sanofi-Aventis, GlaxoSmithKline, Novartis Pharma AG, AstraZeneca, Genomic Health: speakers bureau, consultant or advisory board member and travel support. Teva: travel support. Laura van t Veer: Agendia Inc.: consultant or advisory board member, stock, royalties or equity ownership, employment. Daniel A. Vorobiof: Roche and Novartis: consultant or advisory board member, research and travel support. Amgen: consultant or advisory board member and research support. Sanofi: consultant or advisory board member. Conny Vrieling: No significant relationships. Nicola West: No significant relationships. Eric P. Winer: Genetech: research support. Binghe Xu: No significant relationships.

37 ESO INSIDE TRACK CONFERENCE 2ND BREAST CANCER IN YOUNG WOMEN CONFERENCE In collaboration with Israel Cancer Association 5-7 November 2014 Tel Aviv, Israel Chairs: F. Cardoso, PT - O. Pagani, CH - A. Partridge, US Host Chair: B. Kaufman, IL FURTHER INFORMATION AVAILABLE AT Organising secretariat: Via Turati, Milan - Italy Francesca Marangoni - fmarangoni@eso.net - Tel: Roberta Ventura - rventura@eso.net - Tel: NOVEMBER 2013, LISBON, PORTUGAL ABC2 37

38 NOW APPROVED Advanced Breast Cancer Second International Consensus Conference in HER2+/HR- disease Tyverb in combination with trastuzumab: Vertical Dual Blockade atic breast h chemotherapy move forward to 17.2 months from 8.9 months with Tyverb is indicated for the treatment of adult patients with breast cancer, whose tumors overexpress HER2 (ErbB2); in combination with trastuzumab for patients with hormone receptor negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy5. As with other therapies for HER2 overexpression, Tyverb has been associated with reports of decreases in left ventricular ejection fraction. Prescribing Information (Please refer to full SmPC before prescribing) Tyverb (lapatinib) 250 mg film-coated tablets. Each tablet contains 250 mg lapatinib as ditosylate monohydrate. Indications Treatment of adult patients with breast cancer whose tumours overexpress ErbB2 (HER2). In combination with capecitabine for treatment of patients with advanced or metastatic breast cancer who have received prior therapy including anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting. In combination with trastuzumab for patients with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy. In combination with an llularly 3-5 aromatase inhibitor (AI) for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy 2 patients in the registration study were not previously treated with trastuzumab ffect profile or an AI and no data are available on the efficacy of this combination relative to trastuzumab in combination with an AI in this patient population. Dosage and Administration Only to be initiated by physician experienced in use of anti-cancer medicines. Lapatinib should be taken 1 hour before or 1 hour after food. Standardise administration in relation to food intake. Do not replace missed dose. When given with capecitabine, lapatinib should be given at a dose of 1250 mg (5 tablets) once daily continuously. Capecitabine: 2000 mg/m2/day taken in 2 doses 12 hours apart on days 1-14 in a 21-day cycle. Capecitabine should be taken with food or within 30 mins after food. When given with trastuzumab, lapatinib should be given at a dose of 1000 mg (4 tablets) once daily continuously. Trastuzumab: 4 mg/kg administered as an intravenous loading dose, followed by 2 mg/ kg IV weekly. When given with an AI, lapatinib should be given at a dose of 1500 mg (6 tablets) once daily continuously. AI: Refer to full SmPC of AI for dosing details. Please refer to the SmPC for information on dose delays, 38 ABC2 7-9 NOVEMBER 2013, LISBON, PORTUGAL Caution should be taken if Tyverb is to be administered to patients with severe hepatic impairment due to increased systemic exposure to the drug. The most common adverse events during treatment with the combination of Tyverb and trastuzumab were diarrhea, nausea, rash, fatigue, and vomiting1. dose reductions or interactions. Contra-indications Hypersensitivity to active substance or excipients. Special Warnings and Precautions Decreases in LVEF, in some cases severe reported. Lapatinib has not been evaluated in patients with symptomatic cardiac failure. Caution advised if lapatinib given to patients with conditions that could impair LVEF. Evaluate cardiac function including LVEF in all patients prior to starting treatment to ensure baseline LVEF within institution s normal limits. Evaluate LVEF during treatment to ensure it does not decline to unacceptable level. Caution should be taken if lapatinib is administered to patients with conditions that could result in prolongation of QTc. Consider ECGs with QT measurement prior to and throughout lapatinib treatment. Pulmonary toxicity (including interstitial lung disease/pneumonitis) reported; may be severe. Monitor for symptoms of pulmonary toxicity. Hepatotoxicity has occurred (may rarely be fatal); advise patients of risk. Monitor liver function before initiation of treatment and monthly thereafter or as clinically indicated. The risk of lapatinib-induced hepatotoxicity was associated with carriage of the HLA alleles DQA1*02:01 and DRB1*07:01 Diarrhoea including severe diarrhoea has been reported and can be potentially life-threatening if accompanied by dehydration, renal insufficiency, neutropenia and/or electrolyte imbalances, fatal cases have been reported. Diarrhoea generally occurs early during lapatinib treatment, with almost half of those patients with diarrhoea first experiencing it within 6 days. This usually lasts 4-5 days. Instruct patients to promptly report change in bowel patterns. Proactive management of diarrhoea with anti-diarrhoeal agents is important. Severe cases may require oral or i.v. electrolytes and fluids, use of antibiotics and interruption/ discontinuation of therapy. Caution advised in moderate or severe hepatic impairment or severe renal impairment. Interactions Avoid grapefruit juice during lapatinib treatment. Avoid concomitant treatment with inducers.

39 In the treatment of patients with HER2+/hormone receptor negative (HR-) metastatic breast cancer who have progressed on prior trastuzumab therapy(ies) in combination with chemotherapy Synergize forces to move forward Extend survival with 2 proven, targeted agents Clinically relevant survival benefit in HER2+/HR- disease6 Tyverb in combination with trastuzumab extended median Overall Survival to 17.2 months from 8.9 months with lapatinib alone* (HR=0.62; 95% CI: 0.42, 0.90)6 * Lapatinib is not approved for use as a single agent Cumulative Proportion Alive (%) OS in HER2+ HR- patients treated with Tyverb in combination with trastuzumab compared to lapatinib monotherapy 100 lapatinib 1500mg month improvement in median OS Risk Reduction Tyverb 1000mg + trastuzumab 2mg/kg weekly months % months HR 0.62 ( ) Time from Randomisation (Months) Potentially synergistic, vertical dual blockade of HER2 signaling3 Tyverb combined with trastuzumab targets HER2 intracellularly and extracellularly 3-5 A chemo-free regimen with a predictable and manageable side effect profile 2 Avoid concomitant treatment with inducers and strong inhibitors of CYP3A4 and with medical products with narrow therapeutic windows that are substrates of CYP3A4 or CYP2C8. Avoid grapefruit juice during treatment. Avoid concomitant use of substances that increase gastric ph. Undesirable Effects Please refer to the SmPC for further information. The following adverse reactions have been reported in association with lapatinib as monotherapy or in combination with agents such as capecitabine or letrozole. Very Common: Diarrhoea, nausea, vomiting, dyspepsia, stomatitis, constipation, abdominal pain, rash (including dermatitis acneiform), dry skin, PPE, pruritus, alopecia, anorexia, fatigue, mucosal inflammation, asthenia, pain in extremity, back pain, arthralgia, insomnia, hot flush, headache, epistaxis, cough, dyspnoea. Common: Decreased LVEF, nail disorders including paronychia, hyperbilirubinaemia, hepatotoxicity. Uncommon: Interstitial lung disease/pneumonitis. Rare: Hypersensitivity reactions including anaphylaxis. Specific Events Decreased LVEF: Reported in ~1% of all patients receiving lapatinib across clinical programme and asymptomatic in 70% cases. Symptomatic LVEF decreases observed in ~0.3% of patients on lapatinib either as monotherapy or in combination with other anticancer medicines. Adverse reactions included dyspnoea, cardiac failure, palpitations. In 3 pivotal registration trials, LVEF decreases were reported in 2.5% of patients on lapatinib + capecitabine vs. 1% on capecitabine alone; 6.7% of patients on lapatinib + trastuzumab vs. 2.1% on lapatinib alone and in 3.1% of patients on lapatinib + letrozole vs. 1.3% on letrozole + placebo. Small concentration dependent increase in QTc observed in phase I trial. Diarrhoea: Occurred in ~65% of patients on lapatinib + capecitabine, 62% of patients on lapatinib + trastuzumab and in 64% of patients who received lapatinib + letrozole. Lapatinib-induced diarrhoea is usually low-grade, with severe diarrhoea of NCI CTCAE grades 3 and 4 occurring in < 10% and <1% of patients, respectively. Rash: Occurred in ~28% of patients on lapatinib + capecitabine, 23% of patients on lapatinib + trastuzumab and 45% of patients on lapatinib + letrozole. Generally low grade and did not result in discontinuation of lapatinib. Cost Contact your local GlaxoSmithKline office for pricing information. Marketing Authorisation (MA) no s. EU/1/07/440/ MA Holder Glaxo Group Ltd, 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom. Legal Category Prescription Only Medicine. ONCE/LPD/0042/13. August Adverse events should be reported. Please contact your local medicines authority for further information. Adverse events should also be reported to your local GlaxoSmithKline office. In Portugal please telephone Further information is available from Customer Contact Centre, GlaxoSmithKline, Stockley Park West, Uxbridge, Middlesex UB11 1BT; customercontactuk@gsk.com; Freephone: Tyverb is a registered trademark of the GlaxoSmithKline group of companies. ONCE/LPD/0051/13, Aug 2013 Expiry date: Aug 2014 Tyverb is a registered trademark of the GlaxoSmithKline group of companies. ONCE/LPD/0051/13, Aug 2013 References: Blackwell KL et al. J Clin Oncol. 2012;30(21): Expiry date: Aug Blackwell KL et al. J Clin Oncol. 2010;28(7): Scaltriti M et al. Oncogene 2009;28(6): Trastuzumab Summary of Product Characteristics. 5. Tyverb Summary of Product Characteristics. medicines.org.uk/emc/medicine/20929/spc. Accessed May 22, European Medicines Agency Tyverb Assessment Report, available at: Report_-_Variation/human/000795/WC pdf. Accessed Aug NOVEMBER 2013, LISBON, PORTUGAL ABC2 39

40 FASLODEX IS INDICATED FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH OESTROGEN RECEPTOR POSITIVE, LOCALLY ADVANCED OR METASTATIC BREAST CANCER FOR DISEASE RELAPSE ON OR AFTER ADJUVANT ANTI-OESTROGEN THERAPY, OR DISEASE PROGRESSION ON THERAPY WITH AN ANTI-OESTROGEN Faslodex 250 mg solution for injection fulvestrant. Consult the Summary of Product Characteristics before prescribing. Registration conditions differ from country to country. Please refer to your locally approved license and take this into consideration when viewing this information. Use Faslodex is indicated for the treatment of postmenopausal women with oestrogen receptor positive, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant antioestrogen therapy or disease progression on therapy with an antioestrogen. Presentation A pre-filled syringe contains 250 mg fulvestrant in 5 ml solution. Safety needles (SafetyGlide TM ) are also provided. Dosage and administration Adult females (including the elderly): 500 mg at monthly intervals, with an additional 500 mg dose given two weeks after initial dose. Administered intramuscularly as two consecutive injections, one in each buttock. Faslodex is not recommended for use in children or adolescents, as safety and efficacy have not been established in this age group. No dose adjustments are needed for patients with mild to moderate hepatic or renal impairment (creatinine clearance 30 ml/min). However, safety and efficacy have not been evaluated in patients with severe hepatic or renal impairment. Dosage adjustment is not necessary for patients co-prescribed Faslodex and CYP3A4 inhibitors or inducers. Contraindications Hypersensitivity to the active substance or to any of the excipients, pregnancy, in breast-feeding and in patients with severe hepatic impairment. Precautions Caution in patients with mild to moderate, hepatic impairment and severe renal impairment. Caution if treating patients with bleeding diatheses, thrombocytopenia or those taking anticoagulant treatment. Thromboembolic events are commonly observed in women with advanced breast cancer in clinical trials. There are no long-term data on the effect of fulvestrant on bone. There is a potential risk of osteoporosis with Faslodex. Patients of child-bearing potential should be advised to use effective contraception during treatment. Breast-feeding must be stopped during treatment. Asthenia (a loss of strength) has been reported during treatment with Faslodex, therefore caution if experiencing this symptom when driving or operating machinery. Undesirable events Very common: Nausea, asthenia, injection site reactions, increased liver enzymes. Common: GI disturbances including vomiting, diarrhoea and anorexia; rash; urinary tract infections; hot flushes; venous thromboembolism; headache; back pain; hypersensitivity reactions; elevated bilirubin. Consult SmPC for a full list of side-effects. Legal category Prescription Only Medicine. Marketing Authorisation number EU/1/03/269/002. Faslodex is a trade mark of the AstraZeneca group of companies. SafetyGlide TM is a trade mark of Becton Dickinson and Company. Reporting adverse events or side effects AstraZeneca monitors the safety of our products by collecting, evaluating and reporting adverse events/side effects from a variety of sources. Countries worldwide may have specific processes in place to handle reports of adverse events. Please refer to the manufacturer contact information contained in the prescribing information to report any adverse events/side effects experienced by patients while taking an AstraZeneca prescription drug. October 2013 ATLAS Expiry date 31st December 2013.