A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Paclitaxel Versus Placebo + Paclitaxel as First-line Treatment for Patients with Histologically Confirmed, Locally Advanced (Inoperable) or Metastatic Triple-Negative Breast Cancer (TNBC) (CAPItello-290)
This research study, called CAPItello-290, is for people with advanced triple-negative breast cancer that has spread or cannot be removed by surgery. It's a Phase III trial, which means it's a key step to see if a new treatment is effective and safe enough for widespread use. The study is comparing two treatment combinations: one group will receive a new drug called capivasertib along with a standard chemotherapy drug called paclitaxel, while the other group will receive a dummy drug (placebo) along with paclitaxel. The main goal is to see if adding capivasertib helps people live longer and if the combination is safe. Researchers will also look at how tumours respond and if the treatment affects quality of life.
At a glance
What is this study about?
This study is a very important step in finding better ways to treat advanced triple-negative breast cancer. This type of breast cancer can be more challenging to treat, so doctors are always looking for new and effective options. The study is comparing a new experimental drug, capivasertib, when given alongside a common chemotherapy drug called paclitaxel, against paclitaxel given with a dummy drug (placebo).
When we say 'Phase III', it means this is a large study that aims to confirm if a new treatment is truly effective and safe. Think of it like the final stage of testing before a new medicine might become widely available. The main thing the researchers want to find out is if people who receive capivasertib plus paclitaxel live longer compared to those who just receive paclitaxel plus the placebo. They will also be carefully checking for any side effects.
Beyond simply how long people live, the study will also look at other important things. For example, they'll check if tumours shrink or stop growing, how long these good effects last, and if the treatment improves a person's overall quality of life. All of these details help doctors understand the full picture of a new treatment and whether it's beneficial for patients.
Key takeaways
- This study evaluates a new drug combination for advanced triple-negative breast cancer.
- It aims to see if adding capivasertib to paclitaxel improves survival and is safe.
- Participants will be randomly assigned to receive either capivasertib or a placebo, both with paclitaxel.
- Regular hospital visits and health monitoring will be required.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you would need to be an adult, aged 18 or older. The study is open to both men and women. Importantly, you must have been diagnosed with triple-negative breast cancer that has either spread to other parts of your body (metastatic) or is locally advanced, meaning it cannot be removed by surgery.
This study is designed for patients who have not yet received any treatment for their advanced or metastatic triple-negative breast cancer. It's considered a 'first-line' treatment, meaning it would be the first type of treatment you receive for this stage of your cancer. Your doctors will review your specific medical history and test results to make sure you fit all the detailed requirements for the study.
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 advanced or metastatic triple-negative breast cancer?
- Have you not yet received any treatment for your advanced/metastatic breast cancer?
- Are you able to travel to the study site for regular appointments?
What does participation involve?
If you decide to join this study, you would be randomly assigned to one of two groups, like flipping a coin. One group will receive the new drug capivasertib along with paclitaxel chemotherapy, and the other group will receive a placebo (an inactive dummy drug) along with paclitaxel. Neither you nor your study doctor will know which treatment you are receiving, which helps make the study results fair.
Your participation would involve regular visits to the hospital or clinic. These visits will include various assessments such as physical examinations, blood tests, and scans to monitor your health and how your cancer is responding. The doctors will also ask you to fill out questionnaires about how you are feeling and your quality of life. The treatment period could last for some time, depending on how you respond, and you would have follow-up appointments even after treatment ends to continue monitoring your health and any long-term effects.
Potential risks and benefits
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Common questions
What is 'triple-negative breast cancer'?
It's a type of breast cancer that doesn't have specific receptors (ER, PR, HER2) that are often targeted by other breast cancer drugs. This means different treatments are needed.
What does 'double-blind' mean?
It means that neither you nor your study doctor will know whether you are receiving the active new drug or the placebo. This helps ensure the study results are unbiased.
What is a 'placebo'?
A placebo is an inactive substance that looks just like the real drug. It's used in some studies to compare against the active treatment, to clearly see the drug's effects.
What is 'paclitaxel'?
Paclitaxel is a common chemotherapy drug often used to treat various types of cancer, including breast cancer.
Will I have to pay to be part of this study?
No, you will not have to pay for the study treatment or the extra tests related to the study. This is funded by the research organisation.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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