Active not recruitingPHASE2INTERVENTIONAL

A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment

This research study is investigating a new medication called PF-07220060, given alongside an existing drug called fulvestrant, for people with advanced or metastatic breast cancer. This is breast cancer that doctors don't expect to cure, or that has spread to other parts of the body. Participants will have already received other treatments that weren't fully effective. The study aims to find out how safe and effective this new combination is compared to other standard treatments, which include fulvestrant alone, or a combination of everolimus and exemestane. The goal is to see if PF-07220060 could be a helpful new option for patients in the UK.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Pfizer

Enrolment target

333

Start

09 Jan 2024

Estimated completion

21 Jan 2028

Advanced or Metastatic Breast Cancer

What is this study about?

This study is designed to explore a new potential treatment for people in the UK living with advanced or metastatic breast cancer. 'Advanced' means the cancer is unlikely to be cured with current treatments, and 'metastatic' means it has spread from the breast to other areas of the body. This particular study focuses on breast cancer that is 'hormone receptor (HR)-positive' and 'HER2-negative' – these are specific characteristics of the cancer cells that doctors look for.

The main aim of this study is to learn more about a new medication, PF-07220060, when it's used with an existing drug called fulvestrant. Currently, patients with advanced or metastatic breast cancer often receive a number of treatments. This study is for people whose cancer has continued to progress or grow despite having had previous treatments. Researchers want to compare the new combination against what doctors would normally choose as the next step in treatment.

By comparing the new combination with standard care, the study hopes to determine if PF-07220060, when added to fulvestrant, is a safe and more effective option. This information is critical for developing new and better ways to manage advanced and metastatic breast cancer. The findings could potentially offer a new treatment pathway for patients in the future.

Key takeaways

This study explores a potential new treatment for advanced or metastatic breast cancer.
It's for people whose cancer has progressed after previous treatments.
The new medication, PF-07220060, is combined with an existing drug, fulvestrant.
Participants will be randomly assigned to receive either the new combination or a standard treatment.
It aims to find out if the new combination is safe and more effective.
Your participation is voluntary, and you can withdraw at any time.

Who may be eligible?

You might be able to take part in this study if you are 18 years or older and have advanced or metastatic breast cancer that is hormone receptor positive and HER2 negative. This means your cancer has specific features that respond to hormone-based treatments and doesn't have too much of the HER2 protein. You must have already tried other treatments for your advanced or metastatic breast cancer, and your cancer has progressed.

There are also some reasons why you might not be able to join. For instance, if you have other serious medical or mental health conditions that could make taking part unsafe. You also wouldn't be able to participate if you have very serious, uncontrolled complications from your cancer that require urgent treatment, or if you've recently had certain other treatments like specific anti-cancer drugs or strong radiation therapy. The study also has rules about other medications or supplements you might be taking, as some could interfere with the study drugs. The study team will review all your medical information carefully to see if it's right for 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 of age or older?
Do you have advanced or metastatic breast cancer?
Is your breast cancer 'hormone receptor-positive' and 'HER2-negative'?
Has your cancer continued to grow despite previous treatments?
Are you able to provide a tissue sample from your cancer?
Do you have any serious medical conditions that might make participating unsafe?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned to one of two groups by chance – like flipping a coin. Half of the participants will receive the study medicine, PF-07220060, as tablets to take by mouth twice a day, along with fulvestrant which is given as an injection into a muscle. The other half will receive treatment chosen by the study doctor, which could be fulvestrant injections alone, or everolimus and exemestane tablets taken by mouth once a day.

You will continue to receive the study treatment, and have regular check-ups, scans (like MRI or CT scans), and blood tests. These will monitor how your body is reacting to the treatment, if your cancer is stable, and to look for any side effects. You will remain in the study until your scans show your cancer is getting worse, or if your doctor believes the treatment isn't helping you anymore. You would also stop if you experience side effects that are too severe, or if you decide you no longer wish to take part.

Potential risks and benefits

Participating in this study might offer potential benefits, such as access to a new experimental treatment that isn't widely available yet for your type of cancer. This could include closer monitoring of your health than usual. However, there are also potential risks involved, as with any medication or treatment. The study medicine, PF-07220060, and other treatments, can cause side effects. These can range from mild to severe, and the study team will monitor you closely for any reactions. You'll be given detailed information about these potential risks. Please remember that taking part is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (128)

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

Hoag Health Center Irvine
Verified postcode
Irvine, United States
Hoag Hospital Irvine
Verified postcode
Irvine, United States
Keck Hospital of USC
Verified postcode
Los Angeles, United States
Los Angeles General Medical Center
Verified postcode
Los Angeles, United States
USC/Norris Comprehensive Cancer Center
Verified postcode
Los Angeles, United States
Hoag Memorial Hospital Presbyterian
Verified postcode
Newport Beach, United States
Keck Medical Center of USC Pasadena
Verified postcode
Pasadena, United States
Danbury Hospital
Verified postcode
Danbury, United States
Norwalk Hospital
Verified postcode
Norwalk, United States
Georgetown University Medical Center
Verified postcode
Washington D.C., United States
MedStar Washington Hospital Center
Verified postcode
Washington D.C., United States
Intermountain Health St. Vincent Regional Hospital
Verified postcode
Billings, United States

Common questions

What is 'hormone receptor-positive, HER2-negative' breast cancer?

This refers to specific characteristics of your breast cancer cells. Hormone receptor-positive means the cancer cells grow in response to hormones, and HER2-negative means they don't have high levels of HER2 protein. These details help doctors choose the most effective treatments.

What does 'advanced or metastatic' mean in breast cancer?

Advanced breast cancer is when it's unlikely to be cured with current treatments. Metastatic means the cancer has spread from its original site in the breast to other parts of your body.

Will I definitely receive the new study drug?

No, in this type of study, participants are randomly assigned to one of two groups. You'll either receive the new study drug combination (PF-07220060 plus fulvestrant) or a standard treatment chosen by your study doctor (fulvestrant alone, or everolimus plus exemestane).

What happens if I experience side effects?

The study team will monitor you very closely for any side effects. If you experience any, you should tell the study team immediately. They will assess your symptoms and provide guidance or treatment as needed. You can withdraw from the study if side effects become too severe.

How long will I be in the study?

You will participate in the study for as long as the treatment is helping you, based on scans and your doctor's assessment, and as long as you are not experiencing severe side effects or choose to stop.