Transforming the future for patients with breast cancer

Transcription

1 The personalised breast cancer programme Transforming the future for patients with breast cancer Paving the way to personalised breast cancer care May 2016

2 Introduction Researchers in Cambridge are at the forefront of pioneering research into personalised care for breast cancer patients. The ambition is to pave the way for genetic testing to become a routine part of clinical care and for treatment to be tailored to the unique genetic profile of each patient s tumour. As you are reading this, somewhere in the UK a woman is being told she has breast cancer. Every year, around 50,000 women receive this news that's 137 women every single day. Breast cancer is common one in eight women in this country will receive this diagnosis at some point in their life. Although rare in comparison, the disease also affects men - with equally devastating consequences. Thanks to research, today more people survive breast cancer than ever before. What we currently know about breast cancer Over the past decade there has been significant progress in our understanding of the biology of cancer in general and breast cancer in particular. Advances in genomics have increased our understanding of how tumours develop, grow and spread. We now know that breast cancer is not a single disease but a group of diseases with the common feature being changes in the genome of breast cells that cause abnormal cell growth. The number of genes that can cause cancer if affected by variation is large and, as yet, not finally determined. Diversity at the genetic level means tumours have equally diverse characteristics and vary in their speed of growth and responsiveness to treatment and that some are more The Cambridge Breast Unit at Addenbrooke's Hospital in Cambridge dangerous than others. Ultimately, this means a different quality of life and survival chance for each patient. In recent years, cancer treatment has gradually moved away from the one-size-fits-all approach and towards personalised treatment with stratification of patients based on the molecular makeup of their tumour. This approach has had some success. Early in the diagnosis process, patients today are tested for the presence of specific proteins, for example oestrogen receptor (ER) and human epidermal growth factor receptor (HER2) in their cancer cells and receive treatment that targets these proteins Page 2 of 7

3 However, the current classification of breast tumours has significant limitations. Many patients still face a poor prognosis because effective, targeted treatment for their type of cancer does not exist or the tumour becomes resistant. Further research is needed to develop targeted therapies for all types of breast cancer. I met the most amazing lady whilst having chemotherapy. We went through our treatment together and supported each other, waited with each other. I am the lucky one thanks to wonderful treatment and care, I am alive today. But she isn t and we don t know why. Alison Saunders, breast cancer survivor The METABRIC study a breakthrough in our understanding of breast cancer A major breakthrough in understanding the molecular changes underlying the different types of breast cancer has been generated by Professor Carlos Caldas, in collaboration with Breast Cancer Agency scientists in Vancouver. Professor Caldas is Director of the Cambridge Breast Cancer Research Unit at Addenbrooke s Hospital and Chair of Cancer Research at the University of Cambridge. In this study, one of the largest global studies of breast cancer tissue ever conducted and funded by Cancer Research UK and British Columbia Cancer Foundation, Professor Caldas and his fellow researchers examined the genetic changes that had taken place in breast tumour cells in great detail. As a result of what is known as the METABRIC study, published in 2012, they were able to show which genes had mutated, which genes were working in overdrive and which were being shut down. Based on their specific genetic changes, breast tumours could be grouped into ten different subtypes (the INTCLUST classifier), with each subtype associated with distinct patient outcomes, ie differences in tumour aggressiveness and survival. Page 3 of 7

4 The Personalised Breast Cancer Programme Personalised medicine holds great promise yet its effectiveness in a real-life clinical setting needs to be demonstrate. Currently, Professor Caldas Cambridge team is testing the feasibility and value of using genomic testing in clinical practice, in the real-life NHS setting of the Cambridge Breast Unit. This research aims to translates the findings of the METABRIC study into patient benefit through a personalised approach to breast cancer. Known as the Personalised Breast Cancer Programme, this study is unique in the UK and at the forefront of breast cancer research worldwide. Over 5 years, between 1,500 and 2,000 breast cancer patients (female or male) will be recruited at the Cambridge Breast Unit. For each patient s tumour, a highly detailed DNA profile will be obtained and mutations identified to provide a personal mutation barcode. The study accepts a wide range of breast cancer patients ensuring it will be representative of the wider population. Professor Carlos Caldas, Director of the Cambridge Breast Cancer Research Unit at Addenbrooke s and Chair of Cancer Research at the University of Cambridge The programme objectives are to: CLINICAL APPLICATIONS: Develop the use of genomics to personalise breast cancer care in a real-life clinical setting Use the mutation barcode to predict likely outcomes for patients and, ultimately, help patients understand their prognosis and make informed choices Identify patients best suited to standard treatment, targeted therapies or new drugs in clinical trial RESEARCH APPLICATIONS: Generate new knowledge about genetic mutations, risk factors, and the interplay between the immune system and breast tumours Increase the numbers of patients eligible for genomics-driven clinical trials and inform the design of new trials Show, in the longer term, whether using genomics improves clinical outcomes RESOURCE BUILDING: Create a large database of genomic data linked to patient follow-up which will be valuable for future research Put Cambridge at the centre of the latest developments and strengthen collaborations with existing clinical trials and national efforts (e.g. Genomics England) and other world-leading groups Attract investment from pharmaceutical companies Page 4 of 7

5 Even though my hospital treatment has finished, it isn t over. Every day, I m reminded when I take my medicine and when I see my scars. I m supporting this programme so women in the future can be more confident that they re receiving the best possible treatment for their particular cancer, so they can reconstruct their bodies and their lives as quickly as possible. Joy Martin, breast cancer survivor Project timeline and milestones The study will be conducted in two stages. Stage 1: feasibility for integrating genomic testing into a clinical breast cancer setting This stage involves setting up standard procedures and protocols as well as testing their practical application. Furthermore, this stage involves the setting-up of an expert panel and the development of clinical decision making processes towards tailoring treatment and conveying complex genomic information in a patient-friendly way and linking it to medical records. More than 100 patients will be recruited to test whether reliable DNA sequencing information can be generated in an acceptable timeframe. Stage 2: full clinical implementation (Year 2 to Year 5) Knowledge gained from stage 1 will help shape the implementation of the broader clinical programme in the full cohort of patients, which includes extensive data gathering and demonstration of impact for patients. The vast majority of the 1,500-2,000 breast cancer patients will be recruited in this stage. Transforming breast cancer care Cambridge scientists are driving research to advance breast cancer care. The personalised breast cancer programme bridges the gap between the substantial advances in research and the implementation of improved breast cancer care into routine clinical practice. The study will be conducted at the Cambridge Breast Unit at Addenbrooke s Hospital, a world-leading clinical centre at the heart of a scientific campus with close links to other world-leading research groups and organisations, putting Cambridge at the centre of the latest developments. Over 6,000 people attend the Cambridge Breast Unit every year, and of that number around 500 are diagnosed with breast cancer. Page 5 of 7

6 It sometimes felt like I was spending my whole life in hospital. Each chemo session took hours there were checks, blood tests, a weigh-in and consultation. But I felt really lucky to have such amazing medical treatment on my doorstep and took part in various research trials. If other people hadn t volunteered for research before me, I might not be alive today. Sally Newman, breast cancer survivor The role of Addenbrooke s Charitable Trust (ACT) ACT s mission is to support Cambridge University Hospitals (CUH), which runs Addenbrooke s and the Rosie hospitals, providing benefits for patients over and above those achievable through mainstream funding alone. ACT supports care, research and education. This involves initiating and maintaining translational and clinical research programmes of exceptional relevance to patients and/or the NHS that would not be possible without charitable support. ACT is committed to funding high-quality research expected to generate patient benefits in the short to medium term. We use rigorous selection and monitoring processes, unbiased scrutiny and peer review by qualified experts. ACT has previously funded a broad range of translational research projects and has a long standing partnership with the Cambridge Breast Cancer Research Unit. With approximately half of its previous research funding dedicated to cancer research, ACT is well placed to fund this programme of applied cancer research. To maximise on opportunities in support of this programme, we are aiming to work in close collaboration with the University of Cambridge Development Office (CUDAR). The fundraising campaign To fund the feasibility study (stage 1) and provide three-year funding for essential research posts, ACT has committed to raise 1,163,028. As of April 2016, we have raised 1,048,000, leaving a gap of 115,000. Page 6 of 7

7 Dr Jean Abraham (Honorary Consultant and Senior Clinical Research Associate) was appointed in April 2015, through ACT funding, to oversee progress and implement the project on a day-to-day basis. Recruitment of the feasibiliy study patients, is expected to begin summer The direct cost for the five-year project, reaching 1,500 to 2,000 patients, is estimated at 8.4 million* (*this may change as this is an evolving research programme). On 6 July 2015, ACT launched its Bracode Campaign to raise funds for this programme. Further information can be found at How you can help transform breast cancer care in Cambridge and the UK Today, we are at a tipping point where personalised care for breast cancer patients could become a reality. But we need your help to make this happen sooner rather than later. 5,000* will allow one patient diagnosed with breast cancer to take part in the programme. By supporting this remarkable initiative, you can help us save more lives and play a part in medical history. Please get in touch We hope that you find this programme compelling and will consider giving it your support. If you would like to find out more please contact: Samantha Sherratt, Interim Director of Fundraising at ACT on or by at Samantha.sherratt@act4addebrookes.org.uk or Dr Jenny Longmore, ACT s Director of Research jenny.longmore@addenbrookes.org.uk Addenbrooke s Charitable Trust Box 126 Addenbrooke s Hospital Hills Road Cambridge CB2 0QQ Registered charity number Dr Jean Abraham Honorary Consultant and Senior Clinical Research Associate Page 7 of 7