What are clinical studies?
A clinical study involves human volunteers taking part in studies to evaluate novel methods with the aim of progressing medical knowledge.
Clinical studies can be subtyped into two main categories: observational or interventional studies.
This is where the study is designed to observe people in their normal environment. This can often involve observing behaviours of people, filling out questionnaires or conducting tests. This type of study can help researchers come up with hypothesis to investigate further. It can also generate results by determining associations i.e. that one thing cases another. For example a study could observe that people who attend less than 60% of lectures in college are less likely to do well in final exams.
Interventional studies (often called clinical trials)
As the name suggests this is a study involving people aimed at assessing the use of an intervention to progress our knowledge of a disease. It can involve medical (e.g. novel therapies), surgical or behavioural interventions. These are often used to test if a novel treatment is more effective than currently prescribed treatments. These trials are also used to determine if currently approved drugs could be used on alternative diseases, in combination with other treatment or establish what impact the therapy may have on quality of life. It is the number one way which by which new therapeutics enter the market and become effective therapies for many diseases.
Initiating a clinical trial is a highly regulated and challenging process. Scientists must be able to provide overwhelming evidence from laboratory experiments and studies in animals that the intervention is not dangerous to participants and the outcome of the trial is likely to be favourable. The accumulation of this data is then presented to agencies such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) where it is reviewed and can be given approval for the study to go ahead.
Why do we do clinical studies?
There are many reasons why scientists and doctors conduct clinical studies. Some are outlined below
- The main aim behind clinical studies is to improve the health and quality of life of people.
- Unless clinical trials have been completed you cannot bring a new drug into the market. Therefore they are an essential part of progressing medical treatments.
- We need to know if the novel therapies work better than other treatments already in use.
- They enable us to determine the potential side effects of the drug. This way we can identify people with contraindications that the drug may be harmful to.
- Clinical trials can often benefit patients who disease may have progressed on mainstream therapies and have limited therapeutic options available to them.
What can I do?
Be informed. Learn about clinical studies, how they are conducted, how they can benefit people and also the risks that may be involved in them.
The choice to partake in a clinical study is unique to each individual and their circumstances. Talk to your health care provider to discuss the best possible options which may be available to you.
There are many clinical trials in the area of breast cancer research. These often do not focus specifically on ILC subtype however patient can often participate in these trials.
Here are links to websites in which you can find clinical trials in breast cancer https://www.breastcancertrials.org/BCTIncludes/index.html or https://clinicaltrials.gov/
Clinical trials specifically focusing on ILC include
GELATO trial – This is looking at the use of combining immunotherapy and chemotherapy in metastatic ILC https://clinicaltrials.gov/ct2/show/NCT03147040
PELOPS trial – This trial uses a CDK4/6 inhibitor Palbociclib and endocrine therapy for patients who have not yet had surgery to remove their tumours. https://clinicaltrials.gov/ct2/show/results/NCT02764541
ROLO trial – Here the researchers are assessing how good the combination of crizotinib and fulvestrant is in shrinking lobular breast cancer tumours https://clinicaltrials.gov/ct2/show/NCT03620643
ROSALINE trial – A Clinical Trial for Lobular Breast Cancer. Neoadjuvant Study of Targeting ROS1 in Combination With Endocrine Therapy in Invasive Lobular Carcinoma of the Breast (ROSALINE)ROSALINE phase 2 study will evaluate the efficacy of Entrectinib (a potent inhibitor of ROS1 among other targets) in combination with letrozole (+ goserelin in premenopausal women) in the early setting of ILBC (stages 1 to 3). .https://clinicaltrials.gov/ct2/show/NCT04551495…
- Sponsor: Jules Bordet Institute Collaborator: Hoffmann-La Roche. This single arm, multi-center, phase 2 trial will include pre and post-menopausal women with ER+/HER2- early stage invasive lobular carcinoma of the breast to evaluate the effect of combining endocrine therapy with entrectinib .