A Study to Learn If The Study Medicine Called Fluconazole Changes How the Body Processes The Other Study Medicine PF-07248144
This early-stage study is finding out how a new medicine, PF-07248144, works when taken alongside a common anti-fungal medicine called fluconazole. The new medicine is being developed for people with advanced breast cancer that is hormone receptor-positive (HR+) and HER2-negative (HER2-negative). This type of study, called a Human Pharmacology (Phase I) trial, focuses on understanding how medicines behave in the body. Researchers want to see if fluconazole changes how the body takes in, uses, or gets rid of PF-07248144. This information is important for making sure future treatments are safe and work effectively, especially if patients need to take both medicines.
At a glance
What is this study about?
This study is looking into a new medicine called PF-07248144, which is being developed to help people with a specific type of advanced breast cancer. This cancer is known as hormone receptor-positive (HR+) and HER2-negative (HER2-). When cancer is advanced, it means it has spread to other parts of the body. The main goal of this particular study is not to test if the new medicine treats cancer, but to understand what happens when it's taken at the same time as another common medicine, fluconazole.
Fluconazole is a medicine often prescribed to treat fungal infections. Doctors need to know if taking fluconazole might change how the body processes the new breast cancer medicine. For example, it might change how much of the breast cancer medicine stays in the body, how quickly it's used up, or how it's removed. This kind of information is really important because it helps doctors decide on the right dose of medicines and helps them to make sure treatments are as safe and effective as possible.
This is a very early-stage study, sometimes called a Phase I trial. These trials are usually small and focus on safety and how medicines work in the human body, rather than how well they treat the disease. The results from this study will help researchers understand if there are any important interactions between these two medicines, which will guide how the new breast cancer medicine is used in the future if it is approved for wider use.
Key takeaways
- This study is researching how two medicines interact: a new breast cancer medicine and an anti-fungal medicine.
- It's an early-stage study (Phase I) focused on understanding how medicines work in the body.
- The new medicine is for advanced HR+/HER2- breast cancer.
- Participants must be 18 or older and have advanced HR+/HER2- breast cancer.
- Taking part involves regular clinic visits and close monitoring.
- Your participation helps doctors understand how to use new medicines safely and effectively in the future.
Who may be eligible?
This study is open to adults aged 18 years and older. Both men and women can take part. The study is specifically looking for people with a type of advanced breast cancer that is hormone receptor-positive (HR+) and HER2-negative (HER2-).
If you have other serious health conditions or are taking certain other medications, you might not be able to join. These types of studies often have very strict rules about who can take part to make sure the results are clear and that participants are kept safe. Your doctor will be able to check if you meet all the requirements.
Because this is an early study looking at how medicines interact, there will be other specific health checks and rules. For example, you might need to have certain liver and kidney functions working well, or have a stable health condition overall. The research team will go through all these details with you.
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 advanced breast cancer?
- Has your doctor told you your breast cancer is hormone receptor-positive (HR+) and HER2-negative (HER2-)?
- Are you able to attend regular clinic appointments for monitoring?
- Are you willing to take both study medicines as instructed?
What does participation involve?
Taking part in this study would involve several visits to the clinic. You would receive both the new medicine, PF-07248144, and the anti-fungal medicine, fluconazole, as part of the study. The doctors and nurses would carefully monitor you throughout the study. This would include regular blood tests to see how your body is processing the medicines, as well as other tests to check your overall health and watch for any side effects.
During your visits, you would have physical examinations and answer questions about how you are feeling. The exact number of visits and the total duration aren't specified here, but early-stage studies like this often involve frequent clinic visits and careful monitoring over a period of weeks to a few months. There would also be follow-up appointments after you stop taking the study medicines to ensure your continued well-being.
Potential risks and benefits
Locations (1)
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Common questions
What kind of breast cancer is this new medicine for?
It's for a specific type of advanced breast cancer that is hormone receptor-positive (HR+) and HER2-negative (HER2-).
What is fluconazole?
Fluconazole is a common medicine used to treat fungal infections.
What is a Phase I study?
It's an early-stage study that looks at how a new medicine behaves in the body and its safety, rather than whether it cures a disease.
Will this study help my cancer directly?
The main goal of this study is to understand how medicines interact, not to treat your cancer directly. While you'll be closely monitored, there's no guarantee of personal benefit.
How old do I need to be to join?
You need to be 18 years old or older to take part in this study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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