Fighting breast cancer around the globe - Western Europe

Breast cancer research groups in Western Europe were among the first to join BIG when it was founded in 1999. Today, they recognise the advantages of a major international research organisation in reducing fragmentation of effort and avoiding duplication. However, escalating clinical trial costs, slower access to novel therapies, COVID-19 and even a major cyber-attack on a national healthcare computer system have been among recent challenges reported by leading oncologists in Western Europe to medical journalist, Jenny Bryan.

In the late 1990s, when Professor Hervé Bonnefoi, Professor of Medical Oncology at the University of Bordeaux, and medical oncologist at the Bergonié Cancer Institute, France, began to attend US cancer congresses as a young doctor, there were very few presentations by researchers outside the USA. Two decades later, practice-changing breast cancer trials are reported from all around the world – many of them run by the BIG network of academic research groups that reaches across over 70 countries on six continents.

“BIG’s trials show international academic research at its best, and studies such as HERA, SOFT, MINDACT and, most recently, OLYMPIA, are having a huge impact on breast cancer care for patients,” says Bonnefoi. “Even when BIG trials are not practice changing, they are important because they carry a label of excellence. Moreover, BIG can help to guide development of new drugs in areas or niches that are important to clinicians but are not always a priority for our pharma partners,” he adds.

Dr Evandro de Azambuja, Head of the Medical Support Team at the Institut Jules Bordet, Clinical Trials Support Unit (IJB / CTSU), Brussels, Belgium, agrees that the scientific leadership of BIG trials means that studies are carried out that answer important questions for clinicians and patients.

“If there was no BIG, it would be difficult to carry out trials with the thousands of patients needed to answer important questions and there would be a risk that by the time we had the answers, the questions would be irrelevant. Previously we might have had the same trials carried out in Europe and the USA so there was a lot of duplication, but now we can get

answers with one large international trial,” says de Azambuja.

Large, increasingly complex national and international breast cancer trials cannot be done cheaply, and they have brought an increased administrative and financial burden for researchers across Western Europe, as in other parts of the world.

Professor Michael Gnant, Professor of Surgery at the University of Vienna, and President of the Austrian Breast & Colorectal Cancer Study Group (ABCSG) explains that in the 1990s, one of the first trials in which he was involved had a budget of approximately €3 million for 3,000 patients.

“By the 2000s, that had increased to €30-35 million and, most recently, one needs a budget of €300+ million for 5,000 patients. That’s a 10-fold increase almost every decade, which is surely something that cannot continue,” he says.

Rising costs are not only affecting trial budgets in Western Europe, they are also starting to impede access to new treatments in some countries. Bonnefoi explains that, in the past, the French government was among the first to grant access to new treatments where supportive evidence was strong (for example trastuzumab in the adjuvant setting) but access to new treatments is becoming more difficult, particularly when health authorities consider the benefit to be modest.

Gnant is also seeing a trend towards reduced access to latest breast cancer treatments. “Access to novel cancer treatments in Austria is still among the best in Europe, but we are starting to feel economic pressures, made worse by the COVID-19 pandemic. We still have to act reasonably and, at the same time, decisively because some of these drugs are really very expensive – we try to interact with payers to prevent future problems,” he says.

In Switzerland and The Netherlands, professional advisory groups assess the evidence supporting novel agents, and their recommendations are proving helpful for reimbursement discussions.?

“For the most expensive new drugs, there may be problems with reimbursement and the Ministry of Health has to get involved in negotiations with companies, which can delay access for patients,” says Vincent Dezentjé, medical oncologist at the Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.

Reimbursement negotiations after European Medicines Agency (EMA) approval of new cancer medicines can also cause bottlenecks in Germany, adds Professor Christoph Thomssen, gynaecological oncologist from Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.

“There is a two-step procedure, which means that we have good access in the year after EMA approval, but the Federal Commission for Reimbursement may then question the benefit of a drug and want to negotiate over price. This may deter some physicians from prescribing the drug until the price has been agreed,” he says.

Shortage of oncologists threatens French breast cancer research

As the incidence of breast cancer continues to rise in France, there is growing concern that a shortage of trained oncologists and pathologists will put pressure on services and limit time for research.

“The workload for oncologists is increasing and it is tough to find time for research. The health system does not appear to recognise the importance of research and, while it is good that we are training more oncology nurses, we are not training enough oncologists,” says Bonnefoi.

“We also need biopathologists who can help drive molecular diagnosis of cancer as part of our move towards precision medicine. It makes me concerned not only for the health of our patients but also for our overworked doctors,” he adds.

Under France’s new National Cancer Plan agreed in February 2021, the government has committed €1.74 billion to improving cancer services. However, Bonnefoi explains that the emphasis is on reducing mortality from preventable cancers, such as stopping smoking and reducing alcohol intake, and also on rare tumours, such as pancreatic cancer, with high mortality where there has been little progress in treatment.

“This decision obviously makes sense but breast cancer does not fit well into these categories, though we may get some support for research into triple negative breast cancer. But that overlooks the fact that 12,000 people are still dying from breast cancer each year in France,” says Bonnefoi.

For the Unicancer Breast Group (UCBG) in France, the focus of research is on early diagnosis and personalised treatment, not only at the level of molecular biology but also for patient care, with a strong emphasis on regaining quality of life for cancer survivors.

“The main aims of this survivorship research are to identify patients who are at risk of deteriorating quality of life after breast cancer treatment, owing to long-term drug toxicities or other reasons, and to develop innovative, personalised, multi-modal, digital and in-person support,” explains medical oncologist, Dr Ines Vaz Luis, from Institut Gustave Roussy, Villejuif, France.

In the CANcer TOxicities (CANTO) study of chronic treatment toxicity, over 12,000 patients with localised breast cancer are being followed up over 10 years from diagnosis, with collection of a wide range of clinical, laboratory, biological (‘omic’), social and psychological data.1

“We have clearly identified the main issues that affect the lives of patients after cancer, and we are starting to build predictive models for patients who are likely to develop these issues, initially based on clinical data but also now including biological data, so that in the future we can stratify patients according to the support they are likely to need,” says Vaz Luis.

Progress is also being made in developing multi-modal interventions, with a study due to start that will investigate intensive, tailored support for patients struggling with hormone therapy. In addition, through a national WeShare grant, French and other researchers, starting with young investigators, will have access to digital tools to accelerate quality of life studies.?

French researchers are also leading the European My Personal Breast Screening (MyPeBS) initiative that is comparing a personalised risk-based screening strategy (based on an individual woman’s risk of developing breast cancer) to standard screening.

Vaz Luis explains that risk-based strategies are also being used in ongoing treatment studies, including the PADA-1 trial of hormone switching in patients with metastatic oestrogen receptor positive, HER2-negative breast cancer with an ESR mutation in sequential ctDNA analysis. Iterative ctDNA screening is also being used in the TRAKER study (in collaboration with researchers at the Royal Marsden Hospital, London) to detect resistance mutations in patients with highrisk localised cancer so that early therapeutic intervention can be started. For patients with HER2-positive metastatic breast cancer with isolated brain progressions, the INTERCEPT study is investigating triple therapy with trastuzumab, pertuzumab, and tucatinib to try to significantly delay further progression.?

Integrated breast cancer care and research in the UK

For Professor Judith Bliss, Director of the Institute of Cancer Research Clinical Trials and Statistics Unit (ICRCTSU), London, UK, the practice-changing UK trials that showed the benefits of hypofractionated radiotherapy after primary surgery for early breast cancer are among the most important advances for UK patients of the last two decades.

“These seminal trials have changed the international standard for how radiotherapy is given – from 25 fractions requiring 25 visits to hospital for patients, down to 15 and, most recently to five, without affecting treatment outcomes,” she explains.

Five-year data from the FAST-Forward trial in April 2020 confirming the non-inferiority of five fractions over one week compared to 15 fractions over 3 weeks could not have come at a better time for hard-pressed clinicians working in the midst of the COVID-19 pandemic.6

“There was phenomenal interest right from the start about how five fractions could be safely delivered, and the necessary technical protocols were rapidly shared, and recommendations included in relevant guidelines. The majority of patients in the UK – with the exception of those who need nodal as well as breast radiotherapy – are now given the much shorter course of treatment,” says Bliss.

In parallel with the hypofractionation studies, partial breast radiotherapy research in the UK has also yielded practicechanging results, with some women with early breast cancer now able to avoid whole-breast radiotherapy.7

Bliss explains that breast cancer researchers in the UK can carry out large, pragmatic, non-commercial trials, like the radiotherapy studies, thanks to in-built support services at participating hospital sites, such as data management, provided by the National Institute for Health Research (NIHR). This government-funded organisation was established in 2006 to encourage and fund clinicians and scientists to carry out research within the UK’s National Health Service. In addition, researchers benefit from the long history of charitable giving in the UK to organisations such as Cancer Research UK (CRUK) and Breast Cancer Now, which fund research.

CRUK funding was important for the POETIC study of pre- and peri-operative aromatase inhibition in early breast cancer,8 and NIHR funding enabled the PERSEPHONE trial of trastuzumab treatment de-escalation in early breast cancer to be carried out.9

“The NHS is set up to have research embedded within it so we can carry out non-commercial research on relatively low budgets because we don’t need to reimburse many of the infrastructure costs,” says Bliss.

She explains that the downside of this system is that it is difficult to open non-commercial UK trials to international sites because budgets do not stretch to paying for site-level data management and other support services that the NIHR pays for in the UK, but for which researchers in other countries would need funding.

“It’s not that we don’t want to open our trials to international sites, but we cannot ignore the financial considerations. Brexit has brought additional issues because we now need to have a representative in the EU to cover sponsorship in EU countries,” adds Bliss.

Moving forward, the main priorities for the ICR-CTSU in partnership with National Cancer Research Institute Breast Research Group are for risk-adaptive, personalised treatment for patients with breast cancer. Following the PERSEPHONE study, which showed that six months treatment with trastuzumab was non-inferior to 12 months treatment in HER2-positive early breast cancer, funding has been agreed for the HER2RADiCAL trial. This will aim to minimise additional treatment in patients who achieve a pathological complete response (pCR) after neoadjuvant systemic therapy, in order to reduce treatment toxicity while maintaining efficacy of treatment.

Although the POETIC trial showed that there is no advantage to pre- and peri-operative aromatase inhibition in early breast cancer, it did show the added value of Ki67 as a prognostic biomarker at surgery – after two weeks of an aromatase inhibitor – rather than at pre-treatment baseline.

“It gives us an easier, cheaper diagnostic test than many others to identify patients with emerging endocrine resistance who may need additional therapy, and we have recently initiated POETIC-A to investigate the effects of CDK4/6 inhibition in this high-risk group. So personalised therapy is not just about deescalating treatment, it’s also about possibly increasing treatment for those who need it,” says Bliss.

For patients with emerging metastatic disease, there is a focus on using ctDNA testing for early identification of patients who need treatment, as demonstrated in the plasmaMATCH study.10

“We want to find out if ctDNA can be used to identify markers of a patient’s current disease more effectively than taking a biopsy. Mutations identified through ctDNA may give us a more accurate picture of the active clones that are driving the disease in that patient at that time, and can be used to monitor patients for emerging metastatic disease. However, we need to decide the practicalities of monitoring patients and how this can really work in practice. Our recently completed c-TRAK TN study will give early indications about this,” Bliss concludes.

German research puts neoadjuvant therapy in the spotlight

With the largest population in Western Europe, German breast cancer researchers make a major contribution to practice-changing clinical trials as members of a number of research groups, many of them coordinated through the Arbeitsgemeinschaft Gyn?kologische Onkologie Breast Study Group (AGO-B).

“Over the last 20 years, certification of breast centres in Germany and production of evidence-based guidelines have had a major impact on the organisation of all stages of breast cancer care, and our current priorities are improvements in neoadjuvant treatment, treatment individualisation for sparing chemotherapy, and advances in treatment of triple negative breast cancer,” says Professor Christoph Thomssen.

He explains that, after the SENTINA trial showed that sentinel node biopsy is a reliable diagnostic technique before neoadjuvant therapy but associated with increased false negatives after therapy,11 the AXSANA trial was set up to evaluate surgical techniques for axillary staging (sentinel lymph node biopsy, targeted axillary dissection, axillary dissection) in patients with clinically node-positive breast cancer after neoadjuvant chemotherapy.

Thomssen highlights a series of studies that have improved understanding of optimal regimens in different breast cancer types, including the German Breast Group’s (GBG) recently reported GEPARNuevo study showing that neoadjuvant durvalumab improves long-term outcome in TNBC when added to anthracycline/taxane based chemotherapy.12 Other recently reported data – from the ADAPT trial carried out by the West West German Study Group (WSG)?– showed excellent pCR and survival in patients receiving de-escalated neoadjuvant chemotherapy and dual HER2 blockage in HRnegative, HER2-positive breast cancer.13 Early pCR after 12 weeks was strongly associated with improved outcomes and has potential as a predictive marker for further de-escalation.

With regard to luminal breast cancer, WSG’s ADAPT program studies the predictive impact of Ki-67 drop after a short period of endocrine therapy in order to reduce the need of adjuvant chemotherapy in these patients.

“The main challenges still facing us are risk estimation for reducing chemotherapy in all breast cancer types and better individualisation of neoadjuvant treatment according to subgroups. We also need to explore the relationship between pCR and disease-free survival, how to improve pCR rates with neoadjuvant therapy, and what should be offered to those who do not get a pCR,” says Thomssen.

“In 5 or 10 years'’ time, I hope there will be less surgical intervention – even though I am a surgeon. If we can reduce the rate of false negative biopsy results after neoadjuvant therapy, we may be able to reduce the need for surgery or at least reduce the need for chemotherapy. I am also looking forward to drugs that are as effective as the taxanes but without their neurotoxic effects. All these advances would have an important impact on the quality of life of our patients,” concludes Thomssen.

Treatment de-escalation is a priority in the Netherlands

Celebrating two decades of the Dutch Breast Cancer Research Group (Borstkanker Onderzoek Groep (BOOG)) studies this year, Dutch breast cancer researchers are rightly proud of the impact that multiple trials have had on patient care in The Netherlands since the organisation was established.

“Since 2001, we have recruited over 30,000 patients in The Netherlands to breast cancer trials and, as BOOG is now the most important breast cancer research platform in The Netherlands and nearly all breast cancer oncologists are members; BOOG research has helped to standardise clinical practice in hospitals across the country,” says Vincent Dezentjé, medical oncologist at the Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.

He explains that the TRAIN trials have been important in establishing neoadjuvant therapy as standard of care for patients with HER2-positive breast cancer. After promising data from an initial single arm Phase 2 study,14 TRAIN 2 showed that, in the presence of dual HER2 blockade, non-anthracycline and anthracycline-containing regimens were equally effective but the former was less toxic.15

“Neoadjuvant therapy was previously thought to be logistically complex and disliked by patients, but the TRAIN studies showed the value of this approach, and that anthracycline-free treatment could reduce toxicity,” explains Dezentjé.

TRAIN 3, another single arm, Phase II study is now evaluating the efficacy of image-guided de-escalating neoadjuvant treatment with paclitaxel, carboplatin and dual HER2 blockade in stage II-Ill HER2-positive breast cancer.

“A key part of the BOOG research strategy is treatment deescalation and the aim of TRAIN 3 is to see whether, in patients who have a radiological complete response, three or six courses of neoadjuvant treatment will be as effective as nine courses before breast cancer surgery,” explains Dezentjé.

Recruitment is almost complete to the SONIA trial, which is investigating the optimal place of CDK4/6 inhibitors, either as f irst line treatment with aromatase inhibitors or second line with fulvestrant in patients with hormone receptor positive advanced breast cancer.

“We very much hope to show that giving CDK4/6 inhibitors as second line will be non-inferior to first line, as this will mean fewer hospital visits and potentially better quality of life for patients and more cost-effective treatment,” Dézentjé points out. “SONIA is seen as such an important study in The Netherlands that it has government funding.”

Currently at the planning stage is the SEQUEL-Breast study, which is hoped to provide further insights into optimal endocrine sequencing in patients with advanced breast cancer. This Phase 2 study will investigate the combination of fulvestrant and alpelisib in patients with PIK3CA-mutated, hormone receptor positive, HER2-negative advanced breast cancer, following progression on fulvestrant as second line therapy.?

In addition, the nationwide Triple B study is investigating the optimal chemotherapy backbone (carboplatincyclophosphamide versus paclitaxel) to use with or without atezolizumab immunotherapy as first line treatment in advanced triple negative breast cancer.

“We are also really glad to participate in BIG trials and, in the future, we hope to open up some of our studies to the BIG network, particularly the subgroup studies aimed at answering important questions but for which we don’t have enough patients in The Netherlands. Of course, we hope that BIG can help us set up these international collaborations without the need for increased paperwork, administration, and regulation,” concludes Dezentjé.

Beware of the effects of cyber-attacks on breast cancer care and research

Imagine arriving at work to find that a major cyber-attack has paralysed your country’s health service and you have no access to patient records, appointments, or research data. That was the scenario facing the 18,000 doctors working in Ireland earlier this year, including Professor Seamus O’Reilly, Consultant Medical oncologist at Cork-Mercy and South Infirmary Victoria University Hospitals, Ireland.

“It happened when we were trying to clear the backlog after COVID-19, so the timing was dreadful, and I would recommend that anyone reading this should ask their hospitals how susceptible they are to cyber-attack and what steps they should take to prepare for it. COVID-19 was a ‘speed bump in the road’ compared to ‘the mountain on the motorway’ resulting from our cyber-attack,” he says.

Setting aside recent events, Ireland has seen major improvements in breast cancer survival over the last 20 years – thanks to substantial improvements in treatment and greater integration of care. Patients now receive care through well-defined pathways from primary care to eight large cancer centres across Ireland instead of the previous 30 less specialist hospitals. In parallel, a less well-known benefit of the 1998 Belfast/Good Friday agreement that brought peace to Northern Ireland, was a partnership between the US National Cancer Institute and the Northern Ireland and Ireland governments for the development of cancer services and research.16

“This agreement has been transformative for breast cancer research because it sanctioned government funding for cancer trials in cancer centres throughout the country. It really turbocharged research because we were able to build infrastructure and recruit staff, and develop cross-border synergies, education, training, and career development on an all-Ireland basis,” O’Reilly explains.

He adds that a reorganisation of Ireland’s hospitals into clusters attached to universities with links to the national clinical research organisation, Cancer Trials Ireland (CTIRE), aims to increase the footprint of clinical cancer research and build stronger links between cancer research units and universities.?

“We recognise that many of us can’t work harder but many of us can work better, so we need to decide how to work together and adapt career pathways to the reality of modern working patterns, where doctors don’t just get a job and stay in it for ever as used to be the case,” says O’Reilly.

CT-IRE’s workstreams are currently focused mainly on improving survival and quality of life in early breast cancer through better drug selection, and at reducing side effects of hormone treatment.

“Hormones are one of the key challenges of breast cancer medicine. They are pivotal for treating the disease, but the cost in terms of side effects for patients can be considerable. There is a disparity between clinical reality and patient reality for many of these side effects, and these issues can lead to non-compliance with treatment and worse outcomes. Most of the conversations I have with patients about side effects are not about chemotherapy but about hormone therapy,” says O’Reilly.

Among the trials to which CT-Ireland members are contributing are BIG’s EXPERT trial of personalised radiotherapy in early breast cancer and to the German Breast Group’s SASCIA study of post neoadjuvant treatment with the antibodydrug conjugate sacituzumab govitecan in women with early HER2-negative breast cancer and a high risk of relapse after standard neoadjuvant treatment. They are also recruiting for the KEYNOTE-756 study of pembrolizumab and the CA209-7FL study of nivolumab – both in combination with neoadjuvant or adjuvant hormone treatment in high-risk earlystage ER-positive, HER2-negative breast cancer – and for the KEYLYNK-009 study of olaparib and pembrolizumab in triple negative breast cancer.?

Belgian research: helping to change the international treatment landscape

Over the last 20 years, the Institut Jules Bordet/Clinical Trials Support Unit (IJB/CTSU), Brussels, Belgium, has made a major contribution to practice-changing breast cancer research, including BIG’s HERA and APHINITY trials in early stage HER2-postive breast cancer. IJB also recruited many patients to the MINDACT trial of genomic risk to help identify patients with early breast cancer who can potentially avoid chemotherapy.

“We are very privileged to have been involved in many clinical trials and to be able to rapidly contribute significant numbers of patients to studies of trastuzumab, pertuzumab, CDK4/6 inhibitors and others that have changed the treatment landscape,” says Dr Evandro de Azambuja, Head of the Medical Support Team at the Institut Jules Bordet, Clinical Trials Support Unit (IJB / CTSU), Brussels.

Among current research priorities is an investigation into risk factors for brain metastases in patients with breast and other solid tumours, using the clinical research platform BrainStorm, carried out with researchers in the Oncodistinct network under the supervision of Dr Nuria Kotecki. Clinical and biological data are being collected to identify risk factors for central nervous system (CNS) metastases and better understand the biology of CNS metastases (brain and leptomeningeal). de Azambuja explains that it is hoped that this will lead to the discovery of new treatment targets and help to intensify the multidisciplinary approach for the management of CNS metastases. The translational part of the programme will include the use of cerebrospinal fluid circulating tumour DNA (CSF-ctDNA) as a surrogate for CNS metastases in order to characterise its molecular landscape.

In Belgium, there is also a strong focus on triple negative breast cancer (TNBC), with IJB/CTSU researchers working closely with BIG on the use of immunotherapy and chemotherapy in the adjuvant setting. IJB is also conducting a trial testing combination immunotherapy and chemotherapy as first line treatment in patients with metastatic TNBC. In addition, there is an initiative looking at whether neoadjuvant immunotherapy and radiotherapy can boost response to chemotherapy in patients with luminal breast cancer.

Austria – focusing on early breast cancer

For a country with fewer than 9 million people, Austria has an enviable history of cancer research with nearly 30,000 patients recruited to the Austrian Breast & Colorectal Cancer Study Group (ABCSG) trials since 1984, and patients currently being enrolled in nine breast cancer trials. Although the PALLAS trial, of which the ABCSG was co-sponsor, failed to show that adding palbociclib to adjuvant hormone treatment improved diseasefree survival in patients with HR-positive, HER2-negative early breast cancer, Austria’s breast cancer community has much to be proud of.

“The PALLAS trial is a role model of what can be achieved with global collaboration – recruiting almost 6,000 patients in 21 countries in three years is an achievement that speaks for itself,” says Gnant.

The focus of much of the current research in Austria is on early breast cancer, including the ABCSG’s Phase 2 ATHENE trial, which started in 2020 to investigate the use of atezolizumab in combination with dual HER2 blockade plus epirubicin as neoadjuvant therapy for HER2-positive early breast cancer. ABCSG members are currently also enrolling patients into the international POLAR study of adjuvant palbociclib in combination with endocrine therapy in patients with HRpositive, HER2-negative resected isolated locoregional recurrence of breast cancer. Gnant explains that there is also a lot of translational research being carried out using the ‘huge treasure trove’ of biological material donated by patients.

“About 15 years ago, the ABCSG recognised that, as an academic group, we needed to professionalise our structures if we wanted to carry out independent research. If you want to play in the champions’ league you must have the right equipment, and we now have 71 highly skilled people, including statisticians and data monitoring specialists in the organisation, so that we are well placed for taking the lead in conducting clinical trials,” says Gnant.

As in so many countries, a major challenge for academic breast cancer researchers in Austria is funding, in particular the lack of public and charitable support for clinical trials.

“The general political approach in Austria is that the limited funds that are available should be spent on basic research, so we are more reliant on industry to support clinical trials than clinicians in some countries. However, by ensuring that nearly all breast cancer clinical trials in Austria are coordinated through the ABCSG, we are able to ensure these meet the needs of patients and the aims of our academic members,” says Gnant.

Swiss research emphasises quality of life

Although breast cancer care in Switzerland is not exclusively focused in cancer centres as much as in some other parts of Western Europe, mortality is the lowest in the region. Dr Manuela Rabaglio and Dr Khalil Zaman, oncologists at the University Hospital of Bern and Lausanne, explain that access to standard breast cancer care is consistent across Switzerland, though there may be some differences between city and rural areas.

“People in Switzerland are not used to travelling far for treatment, so breast cancer care is provided locally wherever possible. There is good access to newer drugs, and costs are reimbursed through health insurance, which is mandatory for patients,” explains Zaman.

A new platform has been established through which the Swiss Society of Medical Oncology makes recommendations about access to new drugs, and this is proving very helpful for reimbursement discussions.

Owing to the country’s size, Swiss researchers are mainly involved in local Phase 2 studies, or in international collaborative Phase 3 studies, and there is considerable emphasis on quality of life and treatment safety and toxicity. Three hundred and f ifty patients undergoing aromatase inhibitor (AI) treatment have been recruited to a study to investigate the effects of regular exercise on AI-related arthralgia. Using activity trackers, the study is comparing the impact of an organised exercise programme with that of advice to patients to be as active as possible.

The Swiss Group for Clinical Cancer Research (SAKK) initiated the TAXIS study of tailored vs standard axillary dissection to avoid surgical overtreatment in patients with node positive disease, and the ongoing REDUSE study is comparing the use of monthly and quarterly denosumab for the prevention of skeletal events in patients with breast or prostate cancer metastases.

“In Switzerland, there are good opportunities for breast cancer research either collaborating with other organisations on large studies, or carrying out smaller studies ourselves in niche areas,” says Rabaglio. “Although we have around 5,000-6,000 new cases of breast cancer each year in Switzerland, we are also seeing more patients who are interested in participating in trials, especially in younger age groups,” she adds.

As one of the smaller country members of BIG, Swiss clinicians recognise the importance of the collaboration.

“It is very important for us to participate in BIG trials because it enables us to make a greater contribution to breast cancer research than would otherwise be possible, and we also benefit from being part of the exchange of ideas,” says Rabaglio. “Being able to participate in trials of new agents is very useful to our clinicians because it gives them early experience with them before they are approved, so they are familiar with how to use them and to deal with any adverse effects.”

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