Active not recruitingPHASE3INTERVENTIONAL

Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease

This study is investigating a new medication called PF-07220060, given alongside an established drug called letrozole. It's for adults with a specific type of breast cancer that relies on hormones to grow (HR-positive) and doesn't have too much of a protein called HER2 (HER2-negative). This cancer has either spread locally or to other parts of the body, and patients haven't had prior treatment for this advanced stage. The main goal is to find out if this new combination treatment is both safe and effective when compared to other commonly used treatments like palbociclib, ribociclib, or abemaciclib, also given with letrozole. About half the participants will receive the new drug plus letrozole, while the other half will get one of the approved treatments and letrozole. Researchers will carefully check how well everyone is doing throughout the study.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Pfizer

Enrolment target

1,035

Start

06 Jan 2025

Estimated completion

29 Dec 2037

Breast Cancer

What is this study about?

This study is about finding new ways to treat a common type of breast cancer. Doctors are always looking for better and safer treatments, and this particular study focuses on a new drug called PF-07220060. This new drug is being tested alongside an existing medicine called letrozole, which is already used to treat breast cancer.

The study is specifically for people with breast cancer that has spread, either locally to nearby areas or to other parts of the body. This type of cancer is also hormone-positive (meaning it grows because of hormones like oestrogen) and HER2-negative (meaning it doesn't have high levels of a protein called HER2). The important thing is that participants in this study haven't received any other cancer treatment for their advanced cancer yet.

The main aim is to see if the new drug combination (PF-07220060 plus letrozole) works better or as well as current standard treatments (like palbociclib, ribociclib, or abemaciclib, also with letrozole), and if it's safe for patients. By comparing these treatments, doctors hope to learn if this new option could become a valuable choice for future patients.

Key takeaways

The study is testing a new drug for a specific type of advanced breast cancer.
It compares a new treatment to existing approved medicines.
Participants will receive either the new drug or an existing one, both with letrozole.
You must not have had previous systemic treatment for advanced breast cancer.
Regular clinic visits are essential for monitoring your health and treatment.
You can stop participating in the study at any time.

Who may be eligible?

To join this study, you would typically need to be an adult, aged 18 or older, with breast cancer that has been confirmed by a doctor and has started to spread, either locally or to other parts of your body. Your breast cancer must be hormone receptor-positive (meaning it needs hormones to grow) and HER2-negative (meaning it doesn't have too much of the HER2 protein).

A key requirement is that you haven't received any previous medication for your advanced or spread breast cancer. Your cancer should also be measurable, meaning doctors can see and track its size. However, if your cancer is only in your bones, that can also be considered.

There are also some reasons why you might not be able to join. For example, if you are very unwell, have specific problems with your kidneys or liver, or certain blood conditions. Also, if you've had previous hormone therapy or certain other breast cancer treatments shortly before your cancer came back, you might not be suitable for this particular study.

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 HR-positive, HER2-negative breast cancer that has spread locally or to other parts of your body?
Have you NOT received any prior medication for your advanced or metastatic breast cancer?
Are your kidney, liver, and blood counts generally healthy enough for a study like this?

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. About half the participants will receive the new study drug, PF-07220060, along with letrozole. The other half will receive one of the approved treatments (palbociclib, ribociclib, or abemaciclib) with letrozole, chosen by your study doctor. You won't get to choose which group you're in, but you will receive active treatment.

Throughout the study, you'll have regular visits to the study clinic. During these visits, the study team will monitor your health closely. This will involve various tests and check-ups to see how you are responding to the treatment and to make sure you are tolerating it well. They'll also keep track of any side effects you might experience. The total duration of your participation will depend on how you respond to the treatment and will be discussed in detail with you.

Potential risks and benefits

Patients who take part in this study may or may not benefit directly from the treatment. The potential benefit is that the new study drug might prove to be more effective or have fewer side effects than existing treatments for your specific type of cancer. However, as with all medications, there's a risk of side effects, which the study team will carefully monitor. All study treatments aim to help manage your cancer, but there's no guarantee of a particular outcome. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (463)

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

The Kirklin Clinic of UAB Hospital
Verified postcode
Birmingham, United States
The University of Alabama at Birmingham
Verified postcode
Birmingham, United States
University of Alabama at Birmingham Hospital
Verified postcode
Birmingham, United States
Ironwood Cancer & Research Centers
Verified postcode
Chandler, United States
Ironwood Cancer & Research Centers
Verified postcode
Gilbert, United States
Ironwood Cancer & Research Centers
Verified postcode
Glendale, United States
Ironwood Cancer & Research Centers
Verified postcode
Goodyear, United States
Ironwood Cancer & Research Centers
Verified postcode
Mesa, United States
Ironwood Cancer & Research Centers
Verified postcode
Mesa, United States
Ironwood Cancer & Research Centers
Verified postcode
Phoenix, United States
Ironwood Cancer & Research Centers
Verified postcode
Scottsdale, United States
CARTI Cancer Center Saline County
Verified postcode
Bryant, United States

Common questions

What does HR-positive HER2-negative breast cancer mean?

It means your breast cancer cells have receptors that respond to hormones like oestrogen or progesterone, helping them grow. HER2-negative means your cells don't have too much of a protein called HER2 on their surface.

What is 'metastatic disease'?

This means the breast cancer cells have spread from the original tumour to other parts of your body, such as bones or organs.

Will I know which treatment I'm getting?

In this study, you will be assigned to a treatment group. While you will receive either the new drug or an approved treatment, both with letrozole, you won't get to choose which specific treatment you receive.

Why haven't I had treatment before this study for my advanced cancer?

This study is specifically designed for people newly diagnosed with advanced breast cancer who haven't yet started medication for this stage of their disease. This helps researchers see the clear effect of the study treatments.

How often will I need to visit the clinic?

You will have regular visits to the study clinic. The exact schedule will be explained in detail by the study team, but these visits are important for monitoring your health and treatment.