A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
This study is for adults with a type of advanced breast cancer that is sensitive to hormone therapy, tests negative for HER2, and has a specific genetic change called a PIK3CA mutation. Researchers want to find out if adding a new drug called inavolisib to current standard treatments (a CDK4/6 inhibitor and letrozole) can work better than the standard treatment alone. The study will look at how well the new combination shrinks or controls the cancer, and its safety. This is a Phase 3 trial, meaning it's a later stage study where the new treatment is compared to what's already available to see if it should become a new option for patients.
At a glance
What is this study about?
This study is about finding better ways to treat advanced breast cancer. Advanced cancer means the cancer has spread from where it started to other parts of the body. The type of breast cancer this study focuses on is one that is sensitive to hormones (often called HR-positive) and tests negative for a protein called HER2. Importantly, it's also for people whose cancer has a specific genetic change, or mutation, called PIK3CA. This mutation can make cancer cells grow.
The study involves a new drug called inavolisib. Researchers want to see if adding inavolisib to two drugs already used to treat this kind of breast cancer (a CDK4/6 inhibitor and letrozole) works better than just using the standard two drugs with a placebo (a dummy pill). The main goal is to see if this new combination can more effectively stop the cancer from growing or spreading, and if it's safe to use.
This is a 'Phase 3' study, which means it's a big step before a new treatment might become widely available. Doctors need to find out if the new combination is truly an improvement over current treatments, both in how well it works and if it has manageable side effects. The results will help doctors understand if this new treatment could be a good option for future patients with this specific type of advanced breast cancer.
Key takeaways
- The study tests a new drug, inavolisib, for advanced breast cancer.
- It's for HR-positive, HER2-negative breast cancer with a PIK3CA mutation.
- Compares the new drug combo to existing standard treatments.
- Aims to see if the new treatment is more effective and safe.
- Participation involves taking study drugs and regular check-ups.
- You can stop participating at any time.
Who may be eligible?
To join this study, you would need to be an adult man or woman with breast cancer that has been confirmed by doctors. Your cancer must be HR-positive (meaning its growth is affected by hormones) and HER2-negative. It's also important that your cancer has the specific PIK3CA genetic change.
You might be suitable if your cancer was found to be advanced from the start, or if it has come back after a long period of successful initial treatment. You would generally need to be strong enough to manage daily activities, and your blood and organ tests would need to show they are working well. You’ll also need to be able to provide a tissue sample from your tumour for testing.
However, some things would mean you couldn't take part. For example, if you are pregnant or breastfeeding, or plan to be. You also couldn't have had previous treatments for advanced breast cancer. Certain other health conditions, like specific types of diabetes or active eye or bowel diseases, or if the cancer has spread to the fluid around your brain, would also prevent you from joining this particular 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.
- Do I have advanced breast cancer?
- Is my breast cancer HR-positive and HER2-negative?
- Does my cancer have a PIK3CA genetic mutation?
- Have I not had previous treatment for advanced breast cancer?
- Am I well enough to go about my daily activities?
- Am I not pregnant or breastfeeding?
What does participation involve?
If you join this study, you'll be randomly assigned to one of two groups. One group will receive the new drug (inavolisib) plus the standard CDK4/6 inhibitor and letrozole. The other group will receive a placebo (dummy pill) plus the standard CDK4/6 inhibitor and letrozole. You, your family, and your doctors won't know which group you are in. You will take these medications regularly as instructed by the study team.
You would have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your cancer and check for any side effects. These visits might be frequent initially and then become less often over time. The study will continue as long as the treatment is helping you and you are tolerating it well. There will also be a follow-up period after you stop taking the study drugs, to keep track of your health. The total time you spend in the study will vary depending on how you respond to the treatment, but careful monitoring will continue for several years.
Potential risks and benefits
Locations (227)
- The Dignity Health Cancer InstituteVerified postcodePhoenix, United States· Recruiting
- Disney Family Cancer CenterVerified postcodeBurbank, United States· Recruiting
- Scripps HealthVerified postcodeLa Jolla, United States· Recruiting
- Cancer and Blood Specialty ClinicVerified postcodeLos Alamitos, United States· Recruiting
- Ellison Institute of TechnologyVerified postcodeLos Angeles, United States· Recruiting
- Palo Alto Medical Foundation Research CenterVerified postcodePalo Alto, United States· Recruiting
- Kaiser Permanente - San MarcosVerified postcodeSan Marcos, United States· Recruiting
- Palo Alto Medical Foundation Research CenterVerified postcodeSan Mateo, United States· Recruiting
- Palo Alto Medical Foundation Research CenterVerified postcodeSunnyvale, United States· Recruiting
- Cancer Specialists of North Florida - JacksonvilleVerified postcodeJacksonville, United States· Recruiting
- Tallahassee Memorial HealthCareVerified postcodeTallahassee, United States· Recruiting
- Moffitt Cancer Center-McKinley CampusVerified postcodeTampa, United States· Recruiting
Common questions
What is PIK3CA-mutated breast cancer?
It's a specific type of breast cancer where the cancer cells have a genetic change called a PIK3CA mutation, which can affect how the cancer grows.
What does 'HR-positive, HER2-negative' mean?
HR-positive means the cancer is sensitive to hormones and often responds to hormone-blocking treatments. HER2-negative means the cancer does not have high levels of the HER2 protein.
What is a 'CDK4/6 inhibitor' and 'letrozole'?
These are current standard medications used to treat HR-positive breast cancer. They work by blocking processes that help cancer cells grow.
What is a 'placebo'?
A placebo is an inactive pill that looks just like the study drug. It helps researchers fairly compare the new treatment to the standard treatment.
How long will the study last?
The time you spend in the study will depend on how your body reacts to the treatment and how long the treatment helps you. It will involve regular follow-ups for several years.
How to find out more
Reference Study ID Number: WO45654 https://forpatients.roche.com/
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.