A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
This study is for people with HER2-positive breast cancer that has spread or is advanced. It's investigating a new drug called Inavolisib, used alongside a standard treatment called Phesgo. The aim is to see if combining Inavolisib with Phesgo is more effective and safe than using Phesgo with a dummy treatment (placebo). This new combination would be given as a 'maintenance therapy' after initial treatment has already started working. We're particularly looking at patients whose cancer has a specific change called a PIK3CA-mutation. The study is in its final phase (Phase 3), meaning it's well-developed and aims to confirm these treatments for wider use.
At a glance
What is this study about?
This important study is looking into new ways to treat a type of breast cancer called HER2-positive breast cancer. This is when the cancer cells have a lot of a protein called HER2, which helps them grow. The study is for people whose breast cancer has either spread to other parts of the body (called metastatic) or is advanced and can't be removed with surgery. We want to find out if a new drug called Inavolisib, when added to a common treatment called Phesgo, works better and is safe. Phesgo is a combination of medicines that target HER2.
Imagine your cancer has already started responding to initial treatment. This study is testing if adding Inavolisib at this stage, as a 'maintenance therapy', helps keep the cancer under control for longer. Some people in the study will get Inavolisib plus Phesgo, while others will get a dummy treatment (placebo) plus Phesgo. This allows researchers to compare the two groups fairly and see if Inavolisib makes a real difference. We are especially interested in patients whose cancer has a specific genetic change called a PIK3CA-mutation, as Inavolisib is designed to target this.
Overall, the aim is to find more effective and safer treatments for HER2-positive metastatic or advanced breast cancer. By participating, you could help us understand if this new combination could become a valuable option for future patients. This kind of research is crucial for advancing our knowledge and improving care for serious conditions.
Key takeaways
- This study is for advanced or metastatic HER2-positive breast cancer with a PIK3CA-mutation.
- It tests a new drug, Inavolisib, with Phesgo against Phesgo alone.
- The goal is to find out if the new combination is more effective and safe as maintenance therapy.
- Participation involves regular hospital visits for treatments, checks, and scans.
- You could receive the study drug or a placebo; neither you nor your doctor will know which.
- This research aims to improve future treatment options for this type of breast cancer.
Who may be eligible?
To join this study, your doctor will first check if you meet certain requirements. You need to have HER2-positive breast cancer that has spread or is advanced, and your cancer cells must also show a specific change called a PIK3CA-mutation. You should generally feel well and be able to carry out daily activities without too much difficulty. Your heart function needs to be good, and your blood and organ tests should show that your body is working properly.
There are also some reasons why you might not be able to join. For example, if you've already had certain types of targeted therapy for your advanced breast cancer, or if your cancer has come back very quickly after previous HER2-targeted treatment. People with certain other health conditions like active inflammatory bowel disease, severe liver problems, active lung disease, or uncontrolled diabetes would also not be able to participate. The study also cannot include individuals with active infections or certain serious brain conditions.
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 HER2-positive breast cancer that has spread or is advanced?
- Has my cancer been tested and confirmed to have a PIK3CA-mutation?
- Am I generally feeling well and able to do my daily activities?
- Have I not had certain specific treatments for my advanced breast cancer before?
- Do I not have certain other serious health problems like active severe liver disease or uncontrolled diabetes?
What does participation involve?
If you decide to take part in this study, you will first undergo a full health check-up, including blood tests, scans, and heart checks, to make sure you're suitable. Once enrolled, you will receive either the study drug Inavolisib with Phesgo, or a placebo (dummy drug) with Phesgo. Phesgo is given as an injection under the skin. You will have regular appointments at the hospital for check-ups, blood tests, and scans to see how you are responding to treatment and to monitor for any side effects. These visits will likely be frequent at the start and then become less often over time.
The treatment will continue as long as it is helping you and is safe, or until your doctor decides it's no longer the best option. The total duration of your participation will depend on how you respond to the treatment and the study's requirements, but it could last for several months or even longer. After you stop taking the study treatment, there will be follow-up appointments to monitor your health over time.
Potential risks and benefits
Locations (192)
- Banner Health MD Anderson AZVerified postcodeGilbert, United States· Recruiting
- Disney Family Cancer CenterVerified postcodeBurbank, United States· Recruiting
- City of HopeVerified postcodeCorona, United States· Recruiting
- City of Hope Comprehensive Cancer CenterVerified postcodeDuarte, United States· Recruiting
- City of Hope at Irvine LennarVerified postcodeIrvine, United States· Recruiting
- Ellison Institute of TechnologyVerified postcodeLos Angeles, United States· Recruiting
- Georgetown Uni HospitalVerified postcodeWashington D.C., United States· Recruiting
- Medstar Research InstituteVerified postcodeHyattsville, United States· Recruiting
- Dana Farber Cancer InstituteVerified postcodeBoston, United States· Recruiting
- Henry Ford HospitalVerified postcodeDetroit, United States· Recruiting
- Renown Regional Medical CenterVerified postcodeReno, United States· Withdrawn
- Hackensack University Medical CenterVerified postcodeHackensack, United States· Active not recruiting
Common questions
What is HER2-positive breast cancer?
HER2-positive breast cancer is a type where cancer cells have high levels of a protein called HER2, which helps them grow. Treatments that target HER2 can be very effective.
What is a PIK3CA-mutation?
A PIK3CA-mutation is a specific change in a gene within the cancer cells. This change can sometimes make cancer grow, and researchers are developing drugs like Inavolisib to target it.
What is maintenance therapy?
Maintenance therapy means continuing treatment to keep the cancer under control after initial treatments have already worked to reduce the cancer or stop its growth.
What is Phesgo?
Phesgo is a combination of two medicines (pertuzumab and trastuzumab) given as an injection, used to treat HER2-positive breast cancer.
Will I know if I'm getting the new drug or the placebo?
No, this is a 'blinded' study, meaning neither you nor your doctors will know if you are receiving Inavolisib or the placebo. This helps ensure the results are fair and unbiased.
How to find out more
Reference Study ID Number: WO44263 https://forpatients.roche.com/
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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