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The Breast International Group (BIG)-aisbl is a not-for-profit organisation for academic breast cancer research groups from around the world, with its headquarters in Brussels, Belgium.
BIG facilitates breast cancer research at an international level by stimulating cooperation between its members and other academic networks, and collaborating with, but working independently of, the pharmaceutical industry. Such large-scale cooperation is crucial to make significant advances in breast cancer research, reduce the wasteful duplication of effort and resources, enroll numerous patients more quickly, share data and knowledge, and efficiently answer important scientific questions. Faster and robust study results mean faster direct benefits to patients.
In the early 1990s, breast cancer research in Europe was highly fragmented, with academic groups running many similar trials, but not yet interacting in a way to facilitate collaboration. Together, Professors Martine Piccart and the late Aron Goldhirsch, two European opinion leaders, shared a different vision for the future: groups debating the latest research findings, sharing ideas for new clinical trials and working in harmony to conduct these trials together.
They created BIG in 1996 and the group became a legal entity in 1999. Over 20 years later, BIG constitutes the largest global network dedicated solely to breast cancer. It unites 57 academic research groups based in Europe, Canada, Latin America, Asia and Australasia. These entities are tied to several thousand specialised hospitals and research centres worldwide. More than 30 clinical trials and research programmes are run or are under development under the BIG umbrella at any one time, and several of BIG's past studies are already considered landmark and practice-changing. BIG also works closely with the US National Cancer Institute (NCI) and the North American Breast Cancer Groups (NABCG), so that together they act as a strong integrating force in the breast cancer research arena.
Over the years, BIG has developed and successfully run numerous large, phase 3 clinical trials involving thousands of international investigators and institutions. These clinical trials include HERA (HERceptin Adjuvant), MINDACT (Microarray In Node-Negative and 1 to 3 Positive Lymph Node Disease May Avoid Chemotherapy), and ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation).
Many BIG studies have been practice-changing, for example, putting aromatase inhibitors on the map (BIG 1-98), changing how we treat young women with breast cancer (SOFT), leading to a major breakthrough in treating HER2-positive breast cancer (HERA), or helping physicians evaluate which women with early breast cancer could be spared chemotherapy after surgery (MINDACT).
Most BIG trials incorporate a substantial translational research component and emphasise the collection and banking of biological specimens for the purpose of future research.
While many trials under the BIG umbrella are developed in collaboration with the pharmaceutical industry, BIG also designs and conducts purely academic studies, aiming to answer questions that are essential to patients but with no commercial interest. This is the case for POSITIVE (public name "BIG Time for Baby"), a study that aims to evaluate the safety of interrupting endocrine therapy for young women with hormone-sensitive breast cancer who wish to become pregnant, as well as the pregnancy outcomes. Other research in this category includes AURORA (the "Metastatic Breast Cancer GPS"), EXPERT ("BIG Radio Tuning") and the International Programme of Breast Cancer in Men. AURORA, for example, is an ambitious molecular screening programme aimed at understanding the aberrations driving breast cancer metastasis, understanding the evolution of the disease, and understanding why some tumours respond exceptionally well or very poorly to treatment.
These academic studies are made possible only by the generous support of foundations, individual donors, ambassadors, companies and by the fundraising activities run by BIG's philanthropy unit, BIG against breast cancer.
It is important to note that all of BIG's research activities, whether undertaken with commercial or academic partners, adhere to BIG's Principles of Research Conduct. These principles are designed to ensure that, while trials will meet industry requirements from a regulatory standpoint, BIG and its members remain responsible for determining the research agenda, for controlling the clinical study data, and for presenting and publishing research findings (positive and negative) according to academic standards. In this way, BIG preserves its scientific integrity while developing and conducting collaborative research with a variety of partners.
The Breast International Group is now chaired by Dr. David Cameron (UK). [1] Dr. Martine Piccart is Immediate Past Chair of the Group and President of BIG against breast cancer.
BIG's Co-Founder and Past Vice-Chair Dr. Aron Goldhirsch passed away on 26 February 2020. [2]
The era of cancer chemotherapy began in the 1940s with the first use of nitrogen mustards and folic acid antagonist drugs. The targeted therapy revolution has arrived, but many of the principles and limitations of chemotherapy discovered by the early researchers still apply.
Epirubicin is an anthracycline drug used for chemotherapy. It can be used in combination with other medications to treat breast cancer in patients who have had surgery to remove the tumor. It is marketed by Pfizer under the trade name Ellence in the US and Pharmorubicin or Epirubicin Ebewe elsewhere.
Adjuvant therapy, also known as adjunct therapy, adjuvant care, or augmentation therapy, is a therapy that is given in addition to the primary or initial therapy to maximize its effectiveness. The surgeries and complex treatment regimens used in cancer therapy have led the term to be used mainly to describe adjuvant cancer treatments. An example of such adjuvant therapy is the additional treatment usually given after surgery where all detectable disease has been removed, but where there remains a statistical risk of relapse due to the presence of undetected disease. If known disease is left behind following surgery, then further treatment is not technically adjuvant.
MammaPrint is a prognostic and predictive diagnostic test for early stage breast cancer patients that assess the risk that a tumor will metastasize to other parts of the body. It gives a binary result, high-risk or low-risk classification, and helps physicians determine whether or not a patient will benefit from chemotherapy. Women with a low risk result can safely forego chemotherapy without decreasing likelihood of disease free survival. MammaPrint is part of the personalized medicine portfolio marketed by Agendia.
The Komen Brinker Award for Scientific Distinction was established by Susan G. Komen for the Cure in 1992 to recognize leading scientists for their significant work in advancing research concepts or clinical application in the fields of breast cancer research, screening or treatment.
Breast cancer chemotherapy refers to the use of cytotoxic drugs (chemotherapy) in the treatment of breast cancer.
Triple-negative breast cancer (TNBC) is any breast cancer that either lacks or shows low levels of estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2) overexpression and/or gene amplification. Triple-negative is sometimes used as a surrogate term for basal-like.
Martine J. Piccart-Gebhart is a Belgian medical oncologist. She is a professor of oncology at the Université Libre de Bruxelles and scientific director at the Jules Bordet Institute in Brussels, Belgium. She is also a member of the Belgian Royal Academy of Medicine.
Bernard Fisher was an American surgeon and a pioneer in the biology and treatment of breast cancer. He was a native of Pittsburgh. He was Chairman of the National Surgical Adjuvant Breast Project at the University of Pittsburgh School of Medicine. His work established definitively that early-stage breast cancer could be more effectively treated by lumpectomy, in combination with radiation therapy, chemotherapy, and/or hormonal therapy, than by radical mastectomy.
Trastuzumab emtansine, sold under the brand name Kadcyla, is an antibody-drug conjugate consisting of the humanized monoclonal antibody trastuzumab (Herceptin) covalently linked to the cytotoxic agent DM1. Trastuzumab alone stops growth of cancer cells by binding to the HER2 receptor, whereas trastuzumab emtansine undergoes receptor-mediated internalization into cells, is catabolized in lysosomes where DM1-containing catabolites are released and subsequently bind tubulin to cause mitotic arrest and cell death. Trastuzumab binding to HER2 prevents homodimerization or heterodimerization (HER2/HER3) of the receptor, ultimately inhibiting the activation of MAPK and PI3K/AKT cellular signalling pathways. Because the monoclonal antibody targets HER2, and HER2 is only over-expressed in cancer cells, the conjugate delivers the cytotoxic agent DM1 specifically to tumor cells. The conjugate is abbreviated T-DM1.
Nivolumab, sold under the brand name Opdivo, is a medication used to treat a number of types of cancer. This includes melanoma, lung cancer, malignant pleural mesothelioma, renal cell carcinoma, Hodgkin lymphoma, head and neck cancer, urothelial carcinoma, colon cancer, esophageal squamous cell carcinoma, liver cancer, gastric cancer, and esophageal or gastroesophageal junction (GEJ) cancer. It is used by slow injection into a vein.
NeuVax is a peptide vaccine aimed at preventing or delaying the recurrence of breast cancer in cancer survivors who achieve remission after standard of care treatment. The product's developer is the US biotechnology company Galena Biopharma.
Dr. Cora Sternberg is an American medical oncologist at Weill Cornell Medicine and NewYork-Presbyterian Hospital, serving as a member of the Genitourinary (GU) Oncology Program. Dr. Sternberg facilitates the continued growth and development of clinical and translational research programs in GU malignancies. Dr. Sternberg is an internationally respected leader in the field of medical oncology and urological malignancies and a recognized expert in the area of new drug development. She is known for her seminal contributions in bladder cancer, her strong track record of sustained genito-urinary (GU) oncology leadership and collaboration in multiple practice-changing clinical trials, including novel medicines, and her current role applying her expertise in oncology and GU cancers to precision medicine to further improve outcomes for patients. Dr. Sternberg has been decidedly influential in the development of novel hormonal therapies and checkpoint inhibitors across the landscape of GU oncology as evidenced in her curriculum vitae. She is a globally respected researcher who has lectured extensively at universities and cancer symposia worldwide (>800). As Clinical Director of the Englander Institute for Precision Medicine (EIPM), Dr. Sternberg develops strategies to incorporate genomic sequencing and precision medicine throughout the Weill Cornell Medicine and NewYork-Presbyterian healthcare network, including Lower Manhattan, Brooklyn and Queens.
Eric P. Winer is a medical oncologist and clinical researcher specializing in breast cancer. He is director of Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital at Yale New Haven Health, effective February 1, 2022. He also is Deputy Dean for Cancer Programs at the Yale School of Medicine. From 1997 to 2021, he was the Chief of the Breast Oncology Program at Dana–Farber Cancer Institute in Boston, Massachusetts. Beginning in 2013, he held a range of institutional roles at Dana-Farber, including Chief of Clinical Development, the Thompson Chair in Breast Cancer Research and Director of the Dana-Farber/Harvard SPORE in Breast Cancer. He also served as a Professor of Medicine at Harvard Medical School. He was president of the American Society of Clinical Oncology (ASCO) 2022-2023 and became Chair of the Board in mid-June 2023. His career has been focused on breast cancer treatment and research.
Eftilagimod alpha is a large-molecule cancer drug being developed by the clinical-stage biotechnology company Immutep. Efti is a soluble version of the immune checkpoint molecule LAG-3. It is an APC Activator used to increase an immune response to tumors, and is administered by subcutaneous injection. Efti has three intended clinical settings:
Kathleen I. Pritchard, is the head of oncology at Sunnybrook Health Sciences Centre in Toronto, Canada, specializing in breast cancer therapies, and leading the clinical trials division of the centre. She has authored numerous studies on women's health, breast cancer, hormone replacement therapy, public health, and research methodology. According to Thomson Reuters, Pritchard was one of the most cited researchers in the world in 2014 and 2015.
Anne Louise Rosenberg is an American surgical oncologist retired from practice in Cherry Hill, New Jersey.
Trastuzumab/hyaluronidase, sold under the brand name Herceptin SC among others, is a fixed-dose combination medication for the treatment of HER2-overexpressing breast cancer in adults. It is a combination of trastuzumab and hyaluronidase.
Sherene Loi is an Australian oncologist. She is the 2021 winner of the Australian Prime Ministers Prize for Science, in the category of Frank Fenner Prize for Life Scientist of the Year. Loi is Head of Translational Breast Cancer Research, within the Peter Macallum Cancer Centre. Loi's research has advanced understanding into breast cancer, developing and implementing an immune system biomarker. This biomarker will enable improved management for people with advanced cancer. This biomarker is now part of routine pathology reporting across many countries and also is included in the World Health Organisation Classification of Tumours.
Beth Ann Overmoyer is an American physician and oncologist. She is Director of the Inflammatory Breast Cancer Program at the Dana–Farber Cancer Institute.