Clinical Trials

Research and Clinical Trials

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 about  research developments at all of its educational event; the ED Pan European Conferences, its annual Advocacy Training courses and its biannual Advocacy Leader Conferences.  Furthermore, EUROPA DONNA developed its Clinical Trials and Breast Cancer and The Advocate’s Guide to Understanding Breast Cancer Research booklets to promote better understanding of breast cancer research and clinical trials.

 

EUROPA DONNA and BIG-Breast International Group

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.

 

EUROPA DONNA collaborates with BIG on a number of important projects, including serving on the Steering Committee of the AURORA study.

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.

 

REGISTRIES OF CLINICAL TRIALS

To find information on clinical trials currently running in Europe and throughout the world and results of completed trails, you can consult these sources:

ClinicalTrials.gov, a service of the U.S. National Institutes of Health, is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.  This site currently lists more than 200,000 studies with locations in 195 countries.

The European Union Clinical Trials Register contains information on interventional clinical trials on medicines conducted in the European Union (EU), or the European Economic Area (EEA) which started after 1 May 2004.  This register allows you to search for protocol and results information on: interventional clinical trials that are conducted in the EU and the EEA; clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development. The EU Clinical Trials Register currently displays approximately 30,000 clinical trials with a EudraCT (European Union Drug Regulating Authorities Clinical Trials)  protocol.