Europa Donna promotes the advancement of breast cancer research and seeks to ensure that all women understand fully any proposed treatment options, including entry into clinical trials and their right to a second opinion. In accordance with the Brussels Statement from the 2nd EBCC “Randomised clinical trials represent the most effective way of evaluating new therapies but also offer treatment opportunities. Obstacles to the participation for both patients and clinicians should be as low as possible” Europa Donna provides education concerning research developments at all of its educational events, the Pan European Conferences, the annual advocacy training course and the Advocacy Leader Conferences. In addition, Europa Donna has developed a Training Module for Advocates who serve on Trial Committees.
The following booklets have been developed by Europa Donna to promote better understanding of breast cancer research and clinical trials:
- Clinical trials and breast cancer
- Advocates Guide to Understanding Breast Cancer Research
- Exploring the Role of Advocates in Breast Cancer Research
BIG-Breast International Group Collaboration
The Breast International Group (BIG) is a non-profit organisation for academic breast cancer research groups from around the world, with its Headquarters in Brussels, Belgium. BIG facilitates breast cancer research at international level by stimulating cooperation between its members and other academic networks, and collaborating with, but working independently from, the pharmaceutical industry. Large-scale cooperation is crucial to make significant advances in breast cancer research, reduce wasteful duplication of effort, and optimally serve those affected by the disease.
Founded by leading European opinion leaders in 1996, BIG now constitutes a network of 55 groups based in Europe, Canada, Latin America, Asia and Australasia. These research entities are tied to approximately 3000 specialised hospitals and research centres worldwide. About 30 clinical trials are run or are under development under the BIG umbrella. BIG also works closely with the US National Cancer Institute (NCI) and the North American Breast Cancer Group (NABCG), so that together they act as a strong integrating force in the breast cancer research arena.
International collaboration makes it possible to conduct studies that would not be possible for a single research group or network to carry out on its own, especially as treatments become increasingly targeted. Combining efforts makes it possible to quickly enrol large numbers of patients, or to share data and knowledge and efficiently answer important scientific questions. Faster results mean faster direct benefits to patients.
Europa Donna collaborates with BIG (Breast International Group) on a number of important projects, serving on the BIG Scientific Committee, the Steering Committees of the AURORA study, OLYMPIA and MINDACT trials, and the new Task Force on Survivorship.
AURORA is an international programme for women with MBC to use molecular screening to help physicians and researchers understand both why breast cancer metastasises and why some patients respond poorly to standard treatment, while others respond very well. Primary and MBC tissue as well as blood specimens are being collected and characterised on a large scale. If a genetic mutation is found, a clinical trial that tests a new treatment designed to target that mutation may be proposed to the patient (if the physician finds it appropriate). If no drug or clinical trial is available for a mutation, or if no mutation is found, the physician will choose the best available standard treatment for the patient. A total of 1,000 women and men from about 80 hospitals in 14 European countries are expected to take part initially.
Objectives of the study:
• Improve the understanding of MBC and its underlying causes
• Determine why some tumors respond poorly to standard treatment while others respond well
• Identify potential predictive biomarkers for response and resistance to commonly applied anticancer agents
AURORA will be the first broadly international programme of its kind to focus on Metastatic Breast Cancer in order to improve our understanding of the disease with the hope to develop individualised cures for the future.
MINDACT (BIG 3-04)
The MINDACT trial is sponsored and coordinated by the European Organisation for Research and Treatment of Cancer (EORTC). MINDACT compares a genomic prognostic test (Mammaprint®) developed with micro-array technology to traditional clinical-pathological methods for assessing the risk of breast cancer recurring in women with lymph node negative or 1 to 3 node positive disease. It is expected that this will help physicians and patients make better decisions about who can safely avoid chemotherapy and its potential side effects. Europa Donna sits on the Steering Committee, and previously on the Legal and Ethics Committee and the Spreading of Excellence Committee of the MINDACT trial.
The primary results of MINDACT were published in 2016 in the New England Journal of Medicine.
The long term follow-up results were published in March 2021 in the Lancet Oncology.
The POSITIVE Study (IBCSG 48-14/BIG 8-13): pregnancy after breast cancer
The majority of young women with early breast cancer have hormone-sensitive, or estrogen receptor-positive (ER+) disease, meaning the cancer cells are fed by their own estrogens. These women are therefore treated with anti-hormonal therapy for 5-10 years that impacts the ovaries and prevents conception. Young breast cancer patients often face the disease before having addressed their family planning: they may not have time to wait treatment completion before considering pregnancy. The best available evidence suggests that pregnancy after breast cancer does not increase a woman’s risk of developing a recurrence from her breast cancer and is safe for the baby. However, the available information was collected retrospectively and are not homogeneous. Thus, a controlled prospective study is needed to confirm these results.
The POSITIVE study will determine whether endocrine treatment can be paused for up to two years to allow for conception without increasing the risk of breast cancer recurrence. This study is conducted by the International Breast Cancer Study Group (IBCSG) under the umbrella of the Breast International Group (BIG) and will enroll up to 500 women from more than 150 oncology centers in 20 countries around the world.
The International Breast Cancer Study Group, with the collaboration and financial support of the young patient group of Southern Switzerland “Anna dai Capelli Corti”, has developed a video to promote awareness among the scientific and patient communities about the availability of this important controlled clinical study and to sensitize the health providers about the aspects unique to this population such as fertility and pregnancy. The video sees the participation of two young breast cancer survivors, Dr. Olivia Pagani and Dr. Fedro Peccatori as breast cancer experts and POSITIVE study scientific co-chairs and Dr. Gabriella Bianchi, psycho-oncologist. Dr Pagani is a member of the Europa Donna Board. Tanja Spanic, ED Donna Board member, serves on the Steering Committee.
For more information on participating centers contact: firstname.lastname@example.org
First publication from POSITIVE study August 2021: Who are the women who enrolled in the POSITIVE trial: A global study to support young hormone receptor positive breast cancer survivors desiring pregnancy
Other Research Collaborations
EBCTCG Early Breast Cancer Trialists Collaborative Group
The main purpose of the EBCTCG is to bring together the worldwide evidence from clinical trials in early (ie operable) breast cancer to obtain the most reliable possible assessment of the benefits and risks of different treatments. Europa Donna has two representatives on the Steering Committee.
IBCSG- International Breast Cancer Study Group
Since 1977, IBCSG conducts academic clinical trials in breast cancer, while respecting highest scientific and ethical standards. The patients are at the center of its considerations: the patient’s welfare and quality of life are important research topics. Europa Donna has a representative on the Ethics Committee.
Horizon 2020 is the biggest EU Research and Innovation programme ever with nearly €80 billion of funding available over 7 years (2014 to 2020) – in addition to the private investment that this money will attract it promises more breakthroughs, discoveries and world-firsts by taking great ideas from the lab to the market.
Europa Donna is the patient advocacy representative on the following Horizon 2020 projects that have been funded:
- MESI-STRAT Research Project (MEtabolic SIgnaling STRATification) explores the association between breast cancer metabolism and oncogenic signalling using systems medicine approaches to develop new models for patient stratification. For instance, it develops metabolite marker panels measurable in biological fluids to enable patient stratification, resistance monitoring and clinical decision-making throughout endocrine therapy. Europa Donna is a member of the Advisory Board.
- BOUNCE (Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE Back project) aims to research aspects that influence breast cancer patients’ resilience, and ability to return to normal/everyday life and work after breast cancer treatments. The project starts by modelling the factors that influence resilience. The BOUNCE Consortium includes experts from the field of oncology, computer modelling, psychology, and social medicine from Finland, Greece, Italy, Portugal, and Israel. Europa Donna is a member of the External Advisory Panel.
- MyPEBS (My Personal Breast Screening project) is a randomised-control trial that will compare standard breast cancer with a screening strategy that takes account of a woman’s breast cancer risk. It was launched in January 2018 and is to run for 8 years in 7 participating countries. Europa Donna is a member of the Independent Ethics and Data Monitoring Committee. More Info: https://mypebs.eu/
- PREFERABLE (Project on Exercise for Fatigue Eradication in Advanced Breast cancer to improve quality of life) consortium includes institutions from 6 European countries. PREFERABLE focuses on the role and benefits that structured and individualized exercise can have in the treatment of patients with breast cancer that has metastasised. This project will investigate if exercise can improve quality of life of this patient group. More info: https://www.h2020preferable.eu/
- INSPIRE (INnovative tools for Safety Pharmacology for Integrated cardiovascular safety assessment to REduce adverse events and late stage drug attrition) aims to develop better strategies to evaluate and prevent cardiovascular toxicity and adverse events in new drug candidates in the context of safety pharmacology. A number of (breast) cancer therapies have been reported to cause late-onset cardiovascular adverse events. A substantial part of the research will specifically investigate these late-onset cardiovascular adverse effects of anti-cancer drugs in experimental animal models as well as in a small-scale clinical trial of patients that are treated with anthracyclines. Europa Donna will support the INSPIRE project by joining the scientific advisory board and helping to provide feedback to the Early Stage Researchers and their supervisors, by providing a lecture on cardio-oncology from the patient’s perspective and by supporting the dissemination of research results geared toward patients.