A study to assess the safety and effectiveness of inavolisib plus a cdk4/6 inhibitor and letrozole versus placebo plus a CDK4/6 inhibitor and letrozole in participants with advanced breast cancer
This study is testing a new medication called inavolisib for people with advanced breast cancer. Specifically, it's for breast cancer that is hormone receptor-positive, HER2-negative, and has a particular gene mutation called PIK3CA. Inavolisib aims to block a pathway cancer cells use to grow. Participants will either receive inavolisib along with two commonly used drugs (palbociclib and letrozole) or a placebo (a dummy pill) with palbociclib and letrozole. The main goal is to find out if adding inavolisib is safe and more effective at treating this type of breast cancer. The study is in its final phase of testing and will involve about 450 people.
At a glance
What is this study about?
This study is designed to explore a new treatment approach for a specific type of advanced breast cancer. This cancer is described as 'hormone receptor-positive' (meaning its growth is affected by hormones), 'HER2-negative' (meaning it doesn't have too much of a protein called HER2), and it also has a particular genetic fault called a 'PIK3CA mutation'. This mutation is important because it affects a pathway inside cancer cells that helps them grow.
The new drug being tested is called inavolisib. It's designed to block this PIK3CA pathway. Researchers want to see if adding inavolisib to two standard breast cancer medications, palbociclib and letrozole, will be safer and more effective than taking palbociclib and letrozole with a placebo (a dummy pill that looks like inavolisib but contains no medicine). This is a 'Phase III' study, which means it's one of the final stages of testing, involving a larger number of patients to confirm the drug's safety and effectiveness before it can be widely used.
The study aims to understand if this new combination can better control the cancer and improve outcomes for people with this specific form of advanced breast cancer. The results could help doctors decide on the best way to treat patients in the future who have this particular genetic mutation in their cancer.
Key takeaways
- Tests a new drug (inavolisib) for advanced breast cancer with a specific PIK3CA mutation.
- Compares inavolisib plus standard drugs versus a dummy pill plus standard drugs.
- Participation involves taking daily pills and regular check-ups.
- You will be randomly assigned to a treatment group; neither you nor your doctor will know which one.
- The study aims to see if adding inavolisib is safe and more effective.
- You can stop participating at any time.
Who may be eligible?
To join this study, your breast cancer must be advanced and have certain features. It needs to be 'hormone receptor-positive' and 'HER2-negative'. Crucially, your cancer must also have a specific genetic change called a 'PIK3CA mutation'. This mutation is a key requirement for taking part.
You also need to have not had any previous treatment for advanced breast cancer. If you had treatment for earlier breast cancer, it needs to have been at least two years ago for some types of therapy. You should also be generally well enough to take part and be able to swallow pills.
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.
- Is your breast cancer advanced?
- Is your breast cancer hormone receptor-positive and HER2-negative?
- Has your cancer been tested and found to have a PIK3CA mutation?
- Have you not had previous treatment for advanced breast cancer?
- Are you able to swallow pills?
- Are you willing to use effective birth control if needed?
What does participation involve?
If you join this study, you will be randomly assigned to one of two groups, like flipping a coin. You'll either get inavolisib, palbociclib, and letrozole, or a placebo (dummy pill) instead of inavolisib, along with palbociclib and letrozole. All these medications are taken by mouth as tablets or capsules.
You'll take your medication every day for cycles of 28 days. Treatment will continue for as long as it helps you, or until side effects are too much, or if you decide to stop. The treatment is expected to last from one day up to more than 30 months for some people. You'll have regular checks, including blood tests and scans, to see how you're doing and to monitor for any side effects. Some of these checks might be more frequent than if you weren't in the study. You'll also need to prevent pregnancy if you're a woman of child-bearing age, or if you are a man, you will need to ensure your partner prevents pregnancy.
Potential risks and benefits
Locations (1)
- -Approximate-, England
Common questions
What type of cancer is this study for?
This study is for advanced breast cancer that is hormone receptor-positive, HER2-negative, and has a specific genetic change called a PIK3CA mutation.
What new drug is being tested?
The new drug being tested is called inavolisib, which aims to block a pathway cancer cells use to grow.
Will I know if I'm getting the new drug or the dummy pill?
No, this is a 'double-blind' study, meaning neither you nor your doctors will know if you're receiving inavolisib or the placebo. This helps ensure unbiased results.
How long will I be on the treatment?
Treatment can continue for as long as it's helping you, or until intolerable side effects occur. This could range from a few days to over two-and-a-half years.
Who is paying for this study?
The study is funded by F. Hoffman La Roche, a pharmaceutical company.
How to find out more
Ezio Corera
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.