Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer
This research study is investigating a new treatment approach for specific early-stage breast cancer. It combines a new drug called inavolisib with existing hormone therapy (like tamoxifen or aromatase inhibitors) and anti-HER2 treatment (PHESGO). The type of breast cancer this study focuses on is HER2-positive, hormone receptor-positive (HR-positive), and has a change in a gene called PIK3CA. Researchers want to see if adding inavolisib to the usual treatment before surgery can make it more effective at shrinking the tumour and improving patient outcomes. This is a Phase 2 study, meaning it's still in relatively early stages of testing, looking at whether the treatment works and is safe. Patients will be randomly assigned to receive either the combined therapy or the standard therapy, and their progress will be carefully monitored.
At a glance
What is this study about?
This clinical trial is designed to investigate a new treatment strategy for a particular type of early breast cancer. Doctors are looking at whether adding a new drug, called inavolisib, to the established treatment can lead to better results before surgery. The specific breast cancer they are studying is HER2-positive, hormone receptor-positive (HR-positive), and also has a change, or 'mutation,' in a gene called PIK3CA. These are important characteristics that help doctors understand how a cancer might respond to different treatments.
The usual treatment for this kind of breast cancer often includes hormone therapy (like tamoxifen or drugs called aromatase inhibitors) and a targeted treatment called PHESGO, which works against the HER2 protein. This study aims to compare what happens when inavolisib is added to this standard treatment versus receiving only the standard treatment. The goal is to see if the combination shrinks the tumour more effectively before surgery, which could lead to better long-term outcomes for patients.
This is a 'neoadjuvant' study, which means the treatment is given before surgery. By giving treatment first, doctors can often shrink the tumour, making surgery easier and sometimes more effective. After completing the study treatment, all patients will have surgery or a biopsy to check how well the treatment worked to reduce or remove the cancer cells. This study is important because it could potentially offer a new, more effective treatment option for patients with this specific form of early breast cancer.
Key takeaways
- This study evaluates a new treatment for a specific type of early breast cancer.
- It combines a new drug (inavolisib) with existing hormone therapy and PHESGO.
- The treatment is given before surgery to shrink the tumour.
- Participation involves regular hospital visits for treatment and check-ups.
- You might get access to a new drug, but there are also potential side effects.
- You can stop participating at any time if you wish.
Who may be eligible?
To join this study, you would need to be an adult (18 years or older) with newly diagnosed, early-stage breast cancer that is HER2-positive, hormone receptor-positive (HR-positive), and has a specific change in the PIK3CA gene. This type of cancer must be confirmed by a biopsy.
Your breast tumour needs to be measurable, and you must have good overall health, including normal heart function and healthy blood test results. You shouldn't have started any treatment for this breast cancer yet, and if you are pregnant or breastfeeding, or planning to become pregnant, you would not be able to participate. Both men and women can join.
The medical team will do checks to make sure you meet all the requirements, such as looking at your tumour size, checking various blood tests, and reviewing your heart health. This is to ensure the study is safe for you and that the results can be properly understood.
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 newly diagnosed, early-stage HER2-positive, HR-positive breast cancer with a PIK3CA mutation?
- Have you *not* started any treatment for this breast cancer yet?
- Are you generally in good health, with normal heart function and blood test results?
- Are you not pregnant or breastfeeding, and not planning to become pregnant?
What does participation involve?
If you join this study, you will be randomly assigned to one of two groups: either you'll receive the standard treatment (hormone therapy and PHESGO) or you'll receive the standard treatment plus the new drug, inavolisib. The treatments will be given in cycles, every three weeks, for a total of 18 weeks (6 cycles) before your surgery. PHESGO is given as an injection under the skin.
Throughout the study, you'll have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how the treatment is working. This will continue until you have surgery, if the cancer progresses, if you experience side effects that are too difficult to manage, or if you decide to stop participating. After completing the treatment, you will have surgery or a biopsy to see how much the tumour has responded.
Potential risks and benefits
Locations (29)
- KEM Kliniken Essen-MitteVerified postcodeEssen, Germany· Recruiting
- Hämatologie-Onkologie im Zentrum MVZ GmbHVerified postcodeAugsburg, Germany· Recruiting
- DBZ OnkologieVerified postcodeBerlin, Germany· Not yet recruiting
- Praxisklinik Krebsheilkunde für FrauenVerified postcodeBerlin, Germany· Recruiting
- Onkologische Schwerpunktpraxis BielefeldVerified postcodeBielefeld, Germany· Recruiting
- Department of Breast-Center Holweide - Kliniken der Stadt KölnVerified postcodeCologne, Germany· Recruiting
- Städtisches Klinikum DessauVerified postcodeDessau, Germany· Not yet recruiting
- University Hospital Carl Gustav CarusVerified postcodeDresden, Germany· Recruiting
- Center for Gynecologic OncologyVerified postcodeDüsseldorf, Germany· Recruiting
- Frauenklinik des Universitätsklinikums ErlangenVerified postcodeErlangen, Germany· Not yet recruiting
- Klinik für Gynäkologie und Geburtshilfe Agaplesion Markus KrankenhausVerified postcodeFrankfurt, Germany· Recruiting
- SRH Wald-Klinikum Gera GmbHVerified postcodeGera, Germany· Recruiting
Common questions
What does 'HER2-positive' and 'HR-positive' mean?
These are specific features of your cancer cells. HER2-positive means the cancer has too much of a protein called HER2, and HR-positive means the cancer cells are affected by hormones like oestrogen. These features help doctors choose the best treatments.
What is PIK3CA mutation?
A PIK3CA mutation is a change in a gene within the cancer cells. This change can sometimes make the cancer grow or behave differently, and some treatments are designed to target cells with this specific mutation.
What is 'neoadjuvant treatment'?
Neoadjuvant treatment means that you receive cancer treatment, like chemotherapy or hormone therapy, before you have surgery. The aim is often to shrink the tumour, making surgery easier and potentially more effective.
Will I know which treatment I am getting?
This is an 'open-label' study, which means both you and your study doctor will know whether you are receiving the standard treatment or the standard treatment plus inavolisib.
How long will I be on the study treatment?
The active study treatment before surgery will last for about 18 weeks (6 sessions, given every three weeks). Monitoring and follow-up will continue after that.
How to find out more
Jana Roßney
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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