Platinum and Polyadenosine 5'Diphosphoribose Polymerisation Inhibitor for Neoadjuvant Treatment of Triple Negative Breast Cancer and/or Germline BRCA Positive Breast Cancer
This study is for adults aged 16-70 with specific types of breast cancer: either triple-negative breast cancer or breast cancer due to a faulty BRCA gene. The main goal is to find out if adding a new drug, olaparib, to standard chemotherapy given before surgery (called 'neoadjuvant' treatment) is safe and helps shrink the cancer more effectively. Researchers will look at how well the cancer responds to treatment and if it disappears completely from the removed tissue after surgery. Participants will receive chemotherapy for at least 21 weeks, followed by surgery, and will be followed for up to 10 years. This trial aims to improve treatment options for these particular breast cancers.
Em resumo
Sobre o que é este estudo?
This study is looking into new ways to treat certain types of breast cancer before surgery. It's specifically for people who have breast cancer that is either 'triple-negative' or related to a faulty BRCA gene (sometimes called a 'germline BRCA mutation'). These types of breast cancer can be more challenging to treat, so doctors are always looking for better options.
The main idea is to see if adding a drug called olaparib to the standard chemotherapy treatment given before surgery can make the chemotherapy work better and lead to improved results. Olaparib is a type of drug that targets cancer cells in a specific way, especially in cancers linked to BRCA gene changes. The study wants to find out if this combination treatment is safe and if it helps the cancer shrink more effectively, ideally disappearing completely. This could mean a better chance for patients.
This is a large study that will involve at least 780 patients. Patients will be randomly assigned to different treatment groups, some getting the standard chemotherapy and others getting chemotherapy plus olaparib. The results will help doctors understand if this new approach can become a standard and more effective treatment for these particular breast cancers.
Pontos principais
- This study is for specific types of breast cancer: triple-negative or those with a BRCA gene change.
- It tests if adding olaparib to chemotherapy before surgery improves treatment.
- Participation involves at least 21 weeks of treatment, surgery, and long-term follow-up.
- Patients are randomly assigned to receive either standard chemotherapy or chemotherapy with olaparib.
- The study aims to find safer and more effective treatment options for these cancers.
Quem pode ser elegível?
To be considered for this study, you need to be between 16 and 70 years old and have a confirmed diagnosis of invasive breast cancer. Crucially, your breast cancer must fit into one of two specific categories:
Either you have 'triple-negative breast cancer' (TNBC), which means the cancer cells don't have certain receptors that are usually targeted by other breast cancer drugs. Or, if your cancer isn't triple-negative, you must have a faulty BRCA gene affecting your breast cancer and it must be HER2-negative.
The study also has specific requirements about the size and spread of your cancer, such as if it's T1, T2, T3, or T4, or involves nearby lymph nodes. Your doctors will also need to confirm that you are generally well enough to receive the study treatments, with good blood, liver, and kidney function, and that treatment starts within a certain timeframe after your diagnosis.
Este estudo pode ser adequado para você?
Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.
- Are you between 16 and 70 years old?
- Do you have confirmed invasive breast cancer?
- Is your breast cancer triple-negative OR HER2-negative and linked to a faulty BRCA gene?
- Are you generally well enough for chemotherapy?
- Is your cancer within certain size/lymph node involvement limits?
O que envolve a participação?
If you join this study, you'll first go through a screening process to check if you meet all the requirements, including specific tests on your cancer cells. Once confirmed, you'll be randomly assigned to one of the treatment groups, meaning you might receive the standard chemotherapy, or chemotherapy plus the study drug olaparib, before surgery. You won't get to choose which group you're in.
You'll receive a minimum of 21 weeks of chemotherapy treatment, which will be followed by surgery. During this time, you'll have regular hospital visits and check-ups to monitor your health and how you're responding to treatment. You might also receive other standard medications, like those to help manage side effects from chemotherapy. After your surgery, doctors will continue to follow up with you for a long time, potentially for up to 10 years, to see how you're doing in the long term. There may also be an option to join a sub-study for additional treatment if your cancer hasn't fully responded.
Riscos e benefícios potenciais
Localizações (30)
- Cambridge University Hospitals NHS Foundation Trust & the University of CambridgeCódigo postal verificadoCambridge, United Kingdom· Recrutamento
- Queen's HospitalCódigo postal verificadoBurton-on-Trent, United Kingdom· Recrutamento
- The ChristieCódigo postal verificadoManchester, Reino Unido· Recrutamento
- Pinderfields General HospitalCódigo postal verificadoWakefield, United Kingdom· Recrutamento
- University Hospital AyrCódigo postal verificadoAyr, Reino Unido· Recrutamento
- Hospital de Basingstoke e North HampshireCódigo postal verificadoBasingstoke, United Kingdom· Recrutamento
- Bedford General HospitalCódigo postal verificadoBedford, United Kingdom· Recrutamento
- Royal Bournemouth HospitalCódigo postal verificadoBournemouth, United Kingdom· Recrutamento
- Bristol Haematology & Cancer CentreCódigo postal verificadoBristol, United Kingdom· Recrutamento
- West Suffolk HospitalCódigo postal verificadoBury St Edmunds, United Kingdom· Recrutamento
- Velindre Cancer CentreCódigo postal verificadoCardiff, United Kingdom· Recrutamento
- Colchester General HospitalCódigo postal verificadoColchester, United Kingdom· Recrutamento
Perguntas frequentes
What is 'triple-negative breast cancer' (TNBC)?
Triple-negative breast cancer is a type that doesn't have three common markers (estrogen receptor, progesterone receptor, and HER2 protein). This means it won't respond to treatments that target these features.
What does 'BRCA positive' mean?
It means you have a change or 'mutation' in your BRCA gene (either BRCA1 or BRCA2) that increases your risk of certain cancers, including breast cancer. Sometimes breast cancers with this mutation respond differently to treatments.
What is 'neoadjuvant' treatment?
Neoadjuvant treatment means giving chemotherapy or other treatments before surgery. The aim is often to shrink the tumour to make surgery easier or more effective.
What is olaparib?
Olaparib is a drug that works by blocking an enzyme called PARP. It's particularly effective in targeting cancer cells that have problems with repairing their DNA, which can happen with BRCA gene changes.
How long will I be followed after the treatment?
After your main treatment and surgery, doctors plan to follow up with you for a long time, potentially for up to 10 years, to monitor your health.
Como saber mais
CCTC A Cambridge Cancer Trials Centre
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