Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

C4391022 - AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 3 STUDY OF PF-07220060 PLUS FULVESTRANT COMPARED TO INVESTIGATOR’S CHOICE OF THERAPY IN PARTICIPANTS OVER 18 YEARS OF AGE WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR CDK 4/6 INHIBITOR-BASED THERAPY

This research study, called C4391022, is testing a new treatment combination for advanced breast cancer. It involves a new drug, PF-07220060, given alongside Fulvestrant, which is an existing treatment. This combination is being compared to other standard treatments chosen by the doctor. The study is for people over 18 who have hormone receptor-positive, HER2-negative breast cancer that has spread or is advanced. Importantly, their cancer must have progressed after they've already had a type of treatment called a CDK 4/6 inhibitor. The main goal is to see if the new combination can help people live longer without their cancer growing.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Pfizer Inc.

Enrolment target

174

Start

16 Jul 2024

Hormone receptor-positive her2-negative advanced/metastatic breast cancer

What is this study about?

This study, known as C4391022, is exploring a new treatment approach for a specific type of breast cancer. It focuses on advanced or metastatic breast cancer that is hormone receptor-positive and HER2-negative. This means the cancer growth is often linked to hormones, and it doesn't have high levels of a specific protein called HER2.

The study involves trying out a new medicine, PF-07220060, when it's given together with Fulvestrant. Fulvestrant is an established treatment for this kind of breast cancer. The researchers want to compare this new combination to other standard treatments that doctors might choose for patients in this situation. The main aim is to find out if the new combination is more effective at stopping the cancer from growing and spreading.

This study is for people whose cancer has already been treated with a different type of drug called a CDK 4/6 inhibitor, but their cancer has unfortunately started to grow again. The study is in Phase 3, which means it’s a later stage of research, usually involving a larger group of patients. This phase helps confirm if a new treatment is effective and safe before it can potentially become widely available.

Key takeaways

This study tests a new drug combined with a standard treatment for advanced breast cancer.
It's for hormone receptor-positive, HER2-negative breast cancer that has progressed after a CDK 4/6 inhibitor.
The main goal is to see if the new combination can better control cancer growth.
You would be randomly assigned to either the new combination or another standard treatment.
Participation involves regular hospital visits, monitoring, and quality of life questionnaires.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you must be 18 years old or older. You should have advanced or metastatic breast cancer, specifically the type that is hormone receptor-positive and HER2-negative. This means your cancer's growth is often influenced by hormones and it doesn't overproduce the HER2 protein.

It's important that your cancer has already been treated with a medicine called a CDK 4/6 inhibitor, and unfortunately, your cancer has started to grow again despite that previous treatment. This study is looking for both men and women who fit these criteria, as this type of breast cancer can affect anyone.

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 or metastatic breast cancer?
Is your breast cancer hormone receptor-positive and HER2-negative?
Has your cancer progressed after you previously received a CDK 4/6 inhibitor treatment?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be randomly assigned to receive either the new drug combination (PF-07220060 plus Fulvestrant) or another standard treatment chosen by your doctor (which could include Afinitor, Aromasin, or other options). This random assignment is like flipping a coin to ensure a fair comparison. You would attend regular hospital visits for check-ups, blood tests, and to receive your medication. The study team will carefully monitor how the treatment is working and check for any side effects.

Throughout the study, doctors and nurses will closely track your cancer using scans (like CT or MRI) to see if it's growing, staying the same, or shrinking. You'll also be asked to complete questionnaires about your quality of life, symptoms, and how you're feeling. This helps the researchers understand the full impact of the treatment. The total length of your participation would depend on how your cancer responds to the treatment and your overall health, but you would be followed for some time even after stopping the study treatment.

Potential risks and benefits

Like all medical treatments, there are potential benefits and risks to consider. While there's no guarantee the new treatment will work for you, a potential benefit is that it might be more effective at controlling your cancer than other options. You would also receive close medical attention and monitoring throughout the study. Potential risks include experiencing side effects from the medications, which will be carefully explained to you by the study team. These side effects will be closely monitored. It's very important to remember that joining a clinical study is always voluntary, and you have the right to withdraw at any time for any reason, without it affecting your future medical care.

Locations (14)

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

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Unverified
Sweden
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Czechia
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Bulgaria
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Hungary
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Denmark
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Slovakia
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Belgium
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Italy
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Greece
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Finland
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Germany
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Spain

Common questions

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

This is a common type of breast cancer where the cancer cells grow because of hormones like oestrogen or progesterone. It is 'HER2-negative' because it doesn't involve another protein called HER2.

What does 'advanced/metastatic' mean?

It means the cancer has spread from where it started to other parts of the body, or it is in a later stage.

What is a 'CDK 4/6 inhibitor'?

This is a type of medicine that targets certain proteins in cancer cells to slow down their growth. This study is for people whose cancer has grown after using one of these drugs.

Will I definitely get the new drug combination?

You will be randomly assigned to either receive the new combination or another standard treatment your doctor chooses. It's like a lottery to make the study fair.

How long will I be part of the study?

The length of your participation will depend on how your treatment is going and your health, but you will be monitored for some time.