Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Study to Learn if Multiple Doses of the Study Medicine Called Carbamazepine Changes How the Body Processes the Other Study Medicine PF-07248144

This research study is trying to find out how two specific medicines interact in the body. One medicine is called carbamazepine, and the other is PF-07248144. The study is for people who have a certain type of breast cancer called ER+/HER2- breast cancer that has spread or is difficult to treat. It's a very early stage study (Phase 1) focused on understanding how the body processes these medicines when taken together. Researchers want to see if taking carbamazepine changes how the body handles PF-07248144. This information helps doctors understand the best and safest ways to use these treatments in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Pfizer Inc.

Enrolment target

Start

09 Sep 2025

locally advanced or metastatic ER+/HER2- breast cancer

What is this study about?

This study is investigating how two different medicines, carbamazepine and PF-07248144, behave when they are given at the same time to people with a specific kind of breast cancer. This type of breast cancer is known as ER+/HER2- breast cancer, which means it has certain characteristics that doctors look for. It's also described as 'locally advanced' (meaning it has grown into nearby tissues) or 'metastatic' (meaning it has spread to other parts of the body).

The main goal of this research is to see if taking multiple doses of carbamazepine changes how your body deals with the other medicine, PF-07248144. Our bodies are complex, and sometimes one medicine can affect how another medicine is absorbed, processed, and removed. Understanding these interactions is really important for doctors to know how to give medicines safely and effectively.

This is a very early stage study, sometimes called a Phase 1 study. In this phase, the main focus is on understanding how a medicine works in the human body, its safety, and how it's processed, rather than on whether it cures a disease. The information gathered from this study will help guide future research and ensure that if these medicines are used together, it's done in the best possible way for patients.

Key takeaways

This study helps understand how two medicines, carbamazepine and PF-07248144, interact in the body.
It's for people with a specific type of advanced breast cancer (ER+/HER2-).
It's an early-stage study (Phase 1) focused on medicine safety and how the body processes it.
Participation involves taking medicines and likely several clinic visits for tests.
You can stop participating at any time.
The information gained helps future breast cancer treatments.

Who may be eligible?

To join this study, you would need to be at least 18 years old. People of any age above 18 can take part, and both men and women are welcome to participate.

This study is specifically for individuals who have been diagnosed with a particular type of breast cancer. This is called ER+/HER2- breast cancer, which means your cancer cells have certain features that doctors can test for. Your cancer should also be either 'locally advanced' – meaning it has grown into nearby tissues – or 'metastatic' – meaning it has spread to other parts of the body.

There might be other health requirements or criteria that you'd need to meet to ensure the study is safe and appropriate for you. A doctor or research nurse would discuss all these details with you a lot more thoroughly.

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?
Have you been diagnosed with ER+/HER2- breast cancer?
Is your breast cancer locally advanced or has it spread to other parts of your body?
Are you happy to commit to regular clinic visits and take study medicines as instructed?

Answer every question to see your result.

What does participation involve?

As this is an early-stage study, the exact details of what taking part involves are not fully described yet. However, typically in studies like this, you would likely have several visits to the study clinic during the treatment period. These visits might include blood tests to check how the medicines are affecting your body and to measure drug levels, as well as physical examinations.

You would be given specific instructions on how to take the study medicines, carbamazepine and PF-07248144. It's very important to follow these instructions exactly. The total duration of your participation, including how long you would take the medicines and any follow-up appointments, would be explained to you in detail before you decide to join.

Potential risks and benefits

By taking part, you could be helping doctors learn more about how these medicines work together, which could benefit future patients. However, there might not be a direct health benefit to you personally. As with all medicines, there's a possibility of side effects from carbamazepine and PF-07248144. These would be fully explained to you before you start. You are entirely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Belgium

Common questions

What is ER+/HER2- breast cancer?

This is a type of breast cancer where the cells grow in response to hormones (estrogen receptor positive, ER+) and do not have too much of a protein called HER2 (HER2 negative, HER2-). Doctors test for these features to help decide the best treatment.

What does 'locally advanced or metastatic' mean?

'Locally advanced' means the cancer has grown into nearby tissues but hasn't spread to distant parts of the body. 'Metastatic' means the cancer has spread from where it started to other parts of the body, like the bones or lungs.

What is a Phase 1 study?

A Phase 1 study is the first stage where a new medicine is tested in people. The main goals are to check if it's safe, what dose can be given, and how the body handles it. It's not usually focused on whether the medicine treats the disease.

Will I get better if I join this study?

This study is mainly to learn more about how medicines interact, not to treat your cancer directly. While we hope all research eventually leads to better treatments, a direct benefit to you personally is not the main goal of this particular early-stage study.

What is carbamazepine?

Carbamazepine is a medicine often used to treat conditions like epilepsy or nerve pain. In this study, it's being used to see if it changes how your body processes the other study medicine, PF-07248144.