A Phase II, Multicentre, Open-Label Study to Assess the Efficacy and Safety of Olaparib Monotherapy and Olaparib Plus Durvalumab Combination as Neoadjuvant Therapy in Patients with BRCA Mutations and Early Stage HER2- negative Breast Cancer (OlympiaN)
This study, called OlympiaN, aims to find better treatments for early-stage breast cancer in people who have a specific inherited gene change called a BRCA mutation. This type of breast cancer is also HER2-negative. Researchers are testing two different treatment approaches before surgery: one uses a medicine called olaparib by itself, and the other combines olaparib with another medicine called durvalumab. The main goal is to see how much of the tumour disappears or shrinks after these treatments, before surgery. They also want to understand if these medicines are safe and how they affect people's health overall. This is a Phase II study, meaning it's an early stage but still focused on finding effective treatments.
At a glance
What is this study about?
This study, called OlympiaN, is for people with a specific type of early breast cancer. This cancer is unique because it's linked to a gene change called a BRCA mutation, and it's also HER2-negative. Having a BRCA mutation can sometimes mean your body has trouble repairing damaged cells, which can increase the risk of certain cancers, including breast cancer.
Researchers are investigating new ways to treat this particular kind of breast cancer *before* surgery. This approach is called 'neoadjuvant therapy' and it aims to shrink the tumour as much as possible, potentially making surgery easier and more effective. The study is comparing two different treatment plans: one uses a medicine called olaparib on its own, and the other combines olaparib with another medicine called durvalumab. Both medicines are given through an IV or as tablets.
The main question the researchers want to answer is how effectively these treatments shrink or remove the cancer from the breast and nearby lymph nodes *before* surgery. This is measured by looking at the tissue after surgery. They will also look at other factors like how much the tumour volume changes and, most importantly, if the treatments are safe and what side effects people might experience. This information will help doctors understand if these new treatments could be good options for people with this type of breast cancer in the future.
Key takeaways
- Tests new treatments for early breast cancer with BRCA mutations.
- Compares olaparib alone versus olaparib with durvalumab before surgery.
- Aims to shrink tumours and assess safety.
- Involves regular clinic visits and health checks.
- Offers close medical supervision throughout the study.
Who may be eligible?
To be considered for this study, you would need to be an adult, aged 18 or older. The study is open to both men and women.
Crucially, you would need to have been diagnosed with early-stage breast cancer that is HER2-negative. On top of that, a genetic test must have shown that you have a BRCA mutation.
The research team will have a more detailed list of criteria to make sure the study treatments are right for you and that the results can be properly understood. This might include specific health conditions you have or other treatments you've received.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have early-stage breast cancer that is HER2-negative?
- Have genetic tests shown you have a BRCA mutation?
- Are you generally healthy enough to participate in a clinical study?
What does participation involve?
If you decide to join this study, you would first go through a screening process to make sure you meet all the requirements. If you do, you would receive one of the study treatments (either olaparib alone or olaparib with durvalumab) before you have surgery for your breast cancer. These treatments would likely involve taking tablets or having an infusion (a drip) of medicine.
Throughout the study, you would have regular visits to the clinic. These visits would involve various assessments, such as physical examinations, blood tests, checks of your heart health (like ECGs), and MRI scans to monitor the size of your tumour. The study team would also track any side effects you experience very carefully. After your surgery, there would be a follow-up period to see how you are doing and to understand the long-term effects of the treatment. The total duration of your involvement could be several months, including the pre-surgery treatment, surgery, and subsequent follow-up appointments.
Potential risks and benefits
Locations (5)
- —UnverifiedGermany
- —UnverifiedBelgium
- —UnverifiedAustria
- —UnverifiedItaly
- —UnverifiedSpain
Common questions
What is a BRCA mutation?
A BRCA mutation is a change in a specific gene that makes it harder for your body to repair damaged cells, which can increase the risk of developing certain cancers, including breast cancer.
What does 'HER2-negative' mean?
HER2-negative means that your cancer cells do not have many HER2 proteins on their surface. This is important because it means certain targeted therapies for HER2-positive cancer would not be effective for your cancer.
What is 'neoadjuvant therapy'?
Neoadjuvant therapy is treatment given before the main treatment, like surgery. In this study, it's used to try and shrink the breast cancer tumour before an operation.
What are 'Olaparib' and 'Durvalumab'?
These are medicines being tested. Olaparib is a type of targeted therapy, and Durvalumab is an immunotherapy, which helps your body's immune system fight cancer.
Will I know which treatment I'm getting?
Yes, this is an 'open-label' study, meaning you and your doctors will know which specific treatment you are receiving (olaparib alone or olaparib with durvalumab).
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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