To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
This research study is investigating a new treatment approach for advanced breast cancer. It combines two medicines, Inavolisib and Fulvestrant, to see how effective and safe they are together. This particular study focuses on breast cancer that has a specific genetic change (called PIK3CA mutation), is hormone receptor-positive (HR-positive), and HER2-negative. It's for people whose cancer has progressed after previously being treated with a certain type of modern breast cancer drug called a CDK inhibitor. The main goal is to understand if this new combination can help control the cancer better than current options.
At a glance
What is this study about?
This study is looking into a new way to treat breast cancer that has spread or is advanced. Researchers want to find out if combining two medicines, Inavolisib and Fulvestrant, can be a good treatment option. Fulvestrant is a hormone therapy, and Inavolisib is a newer medicine that targets a specific pathway in cancer cells.
This study is for a particular type of breast cancer: one that is hormone receptor-positive (meaning its growth is driven by hormones), HER2-negative (meaning it doesn't have too much of a certain protein called HER2), and has a specific genetic change called a PIK3CA mutation. This genetic change is important because Inavolisib is designed to work against cancers with this mutation. The study is also for people whose cancer has already been treated with a different type of modern breast cancer drug called a CDK inhibitor, but the cancer has started to grow again.
The main aim is to see how well this combination of medicines works to reduce the cancer or stop it from growing, and also to understand its safety. By joining, you could help doctors learn more about better ways to treat this specific type of advanced breast cancer in the future.
Key takeaways
- This study is for advanced breast cancer patients who have a specific genetic change (PIK3CA mutation).
- It's exploring a new combination therapy (Inavolisib + Fulvestrant).
- It's for those whose cancer has progressed after prior treatment with a CDK inhibitor.
- The main goals are to check how well the treatment works and its safety.
- Participation involves regular clinic visits for checks, medicines, and scans.
- You can withdraw from the study at any time.
Who may be eligible?
To be considered for this study, you would generally need to have breast cancer that has been confirmed as hormone receptor-positive and HER2-negative. Your cancer should have progressed after or during treatment with a combination of a CDK4/6 inhibitor and hormone therapy. Doctors would also need to be able to measure your cancer to see how it responds to treatment.
An important requirement is that your cancer must have a specific genetic change called a PIK3CA mutation. This is a key part of the study. You should also be well enough to generally take part in all study activities and not require chemotherapy right now. It's also important that your doctors believe you have a life expectancy of more than six months.
However, you would not be able to join if you have a rare type of breast cancer called metaplastic breast cancer. People who have type 1 diabetes or type 2 diabetes that needs ongoing daily treatment are also generally not eligible. If you've already had certain other types of targeted drugs (like PI3K/Akt/mTOR inhibitors) for your advanced cancer, or if you need daily oxygen or have active lung conditions, you might also not be able to participate.
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.
- Have I been diagnosed with advanced breast cancer that is HR-positive and HER2-negative?
- Has my cancer genetic test shown a PIK3CA mutation?
- Has my cancer progressed after or during treatment with a CDK4/6 inhibitor and hormone therapy?
- Am I generally well, without needing daily oxygen or having active serious lung conditions?
- Do I have type 1 diabetes or type 2 diabetes that requires daily ongoing treatment?
- Have I been told I have metaplastic breast cancer?
What does participation involve?
The specific details of what taking part involves will be fully explained by the study team, but generally, it would include regular visits to the clinic for check-ups and assessments. You would be given the study medicines, Inavolisib and Fulvestrant, which likely involve taking tablets and possibly injections. These visits will help doctors monitor how you are reacting to the treatment, if it is working, and if you are experiencing any side effects.
Assessments would include blood tests, scans (like CT or MRI scans) to measure your cancer, and physical exams. You might also be asked to fill out questionnaires about how you are feeling. The exact number of visits and the duration of the study can vary, and would be discussed in detail, but you would be regularly monitored throughout the treatment period and for a follow-up period afterwards.
Potential risks and benefits
Locations (19)
- Los Angeles Cancer NetworkVerified postcodeLos Angeles, United States· Recruiting
- Astera Cancer Care East BrunswickVerified postcodeEast Brunswick, United States· Recruiting
- Centro Oncologico KorbenUnverifiedCiudad Autonoma Buenos Aires, Argentina· Recruiting
- Hospital Provincial del CentenarioVerified postcodeRosario, Argentina· Recruiting
- Bendigo Cancer CentreVerified postcodeBendigo, Australia· Recruiting
- Cliniques Universitaires St-LucVerified postcodeBrussels, Belgium· Recruiting
- Jessa Zkh (Campus Virga Jesse)Verified postcodeHasselt, Belgium· Recruiting
- UZ Leuven GasthuisbergVerified postcodeLeuven, Belgium· Recruiting
- Hospital Universitari Vall d'Hebron;OncologyVerified postcodeBarcelona, Spain· Recruiting
- Hospital Universitario San CecilioVerified postcodeGranada, Spain· Recruiting
- Hospital Universitario 12 De OctubreVerified postcodeMadrid, Spain· Recruiting
- Hospital Clinico Universitario de ValenciaVerified postcodeValencia, Spain· Recruiting
Common questions
What is a PIK3CA mutation and why is it important for this study?
A PIK3CA mutation is a specific change in the genes of your cancer cells. It's important for this study because one of the medicines, Inavolisib, is designed to target cancers with this particular genetic change.
What does 'HR-positive, HER2-negative' mean?
HR-positive means your breast cancer cells have receptors that respond to hormones like oestrogen, which can help the cancer grow. HER2-negative means your cancer cells don't have too much of a protein called HER2. These details help doctors choose the right treatments.
What is a 'CDK inhibitor' and why does it matter if I've had one?
CDK inhibitors are a type of modern drug often used to treat advanced HR-positive, HER2-negative breast cancer. This study is specifically for people whose cancer has progressed after they've already been treated with one of these drugs.
How long will I be in the study if I join?
The exact length of time you'd be in the study can vary. You would receive treatment for as long as it is helping and you are tolerating it well. There would also be a follow-up period after you stop treatment, which the study team will explain.
Will I know if I'm getting the active drugs or a placebo?
This study is comparing two active treatments (Inavolisib + Fulvestrant) to see which approach works best. You will not receive a placebo, but you will receive one of the specific combinations being tested.
How to find out more
Reference Study ID Number: WO46063 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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