A randomized phase III trial of trastuzumab + ALpelisib +/- fulvestrant versus trastuzumab + chemotherapy in patients with PIK3CA mutated previously treated HER2+ Advanced BrEasT cancer. “ALPHABET Study”
This important study, called the ALPHABET Study, is looking into new ways to treat a specific type of advanced breast cancer. This cancer is known as HER2-positive breast cancer, and it also has a particular change in a gene called PIK3CA. Patients in this study have already received some treatment for their cancer. The study aims to compare a new drug called alpelisib, given with other established treatments, against a standard chemotherapy combination. Researchers want to see if the new treatment can delay the cancer's growth or spread for a longer period. They will also look at how long people live, how well the new treatment shrinks the cancer, and any side effects.
At a glance
What is this study about?
This study, called the ALPHABET Study, is for people who have a specific type of advanced breast cancer. "Advanced" means the cancer has spread from where it started. The cancer being studied is HER2-positive, which means it has a lot of a protein called HER2 on its surface. It also has a specific change in its genes called a "PIK3CA mutation." This study is for people who have already had some treatment for their HER2-positive advanced breast cancer, including a common drug called trastuzumab.
The main aim of the study is to test a new treatment combination. You might receive a drug called alpelisib along with other standard treatments, or you might receive a different standard treatment combination that includes chemotherapy. The researchers want to see if the new combination can keep the cancer from growing or getting worse for a longer time compared to the standard treatment. They will be very carefully monitoring everyone in the study to see how well the treatments work.
Taking part in a study like this helps doctors learn new and better ways to treat cancer. While there's no guarantee the new treatment will work for everyone, your participation is valuable and contributes to medical knowledge that can help future patients. The study will also look at how different treatments affect people's quality of life and any side effects they might experience.
Key takeaways
- This study is testing new treatments for a specific type of advanced breast cancer.
- It's for people with HER2-positive breast cancer and a PIK3CA genetic change who have already had some treatment.
- The main goal is to see if a new drug combination can keep the cancer from growing for longer.
- You will be closely monitored for how well the treatment works and any side effects.
- Participation helps scientists learn more, potentially benefiting future patients and offering you access to new treatments.
Who may be eligible?
To join this study, you need to be at least 18 years old. Both men and women can take part. The study is specifically for people who have advanced breast cancer that is HER2-positive and also has a specific genetic change called a PIK3CA mutation.
You must have already received some treatment for your advanced breast cancer that included a drug called trastuzumab. This means the study is for people whose cancer has returned or progressed after earlier treatments.
Before joining, doctors will check your medical history and test results to make sure this study is the right fit for you. They will explain everything clearly to ensure you understand if you meet the requirements.
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 HER2-positive advanced breast cancer?
- Does your cancer have a PIK3CA gene mutation?
- Have you already received treatment for your advanced breast cancer that included trastuzumab?
What does participation involve?
If you decide to join this study, you will be randomly assigned to one of the treatment groups – like flipping a coin, but it's done by a computer to ensure fairness. You would then receive the specific medications outlined for your group. This would involve regular visits to the hospital or clinic for treatment, check-ups, and tests like scans to see how your cancer is responding. Doctors and nurses will also carefully monitor any side effects you might experience. The total length of your participation would depend on how your cancer responds to the treatment and your overall health, and you would have regular follow-up appointments.
Potential risks and benefits
Locations (1)
- —UnverifiedSpain
Common questions
What does 'HER2-positive' mean?
HER2-positive means your cancer cells have a lot of a protein called HER2, which can make the cancer grow faster. Specific treatments target this protein.
What is PIK3CA mutation?
A PIK3CA mutation is a specific change in a gene within your cancer cells. Some treatments are designed to work better for cancers with this particular change.
What does 'advanced breast cancer' mean?
Advanced breast cancer means the cancer has spread beyond the breast to other parts of the body. It is also sometimes called metastatic breast cancer.
Why is this study important for me?
This study is important because it's testing a new approach that might offer a better treatment option for your specific type of breast cancer, potentially keeping it stable for longer.
Will I definitely get the new drug?
No, not definitely. Participants are randomly assigned to one of the treatment groups, so you might receive the new drug combination or a standard treatment combination.
How to find out more
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.