Active not recruitingPHASE3INTERVENTIONAL

A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer

This study is looking into a new medicine called ARV-471 (also known as vepdegestrant) for people with advanced breast cancer that has spread to other parts of the body. Advanced breast cancer can be hard to treat. The study compares ARV-471 with fulvestrant, a medicine already used for breast cancer. Researchers want to see if ARV-471 is safe and works well. They are looking for adults whose breast cancer has come back or spread, cannot be fully removed by surgery or radiation, and has responded to certain hormone treatments in the past, including a CDK4/6 inhibitor. Participants will take either ARV-471 by mouth daily or receive fulvestrant injections. The treatment continues as long as it's helping or side effects aren't too bad.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Pfizer

Enrolment target

624

Start

03 Mar 2023

Estimated completion

15 May 2028

Advanced Breast Cancer

What is this study about?

This study is designed to learn more about a new medicine called ARV-471, which is also known as vepdegestrant, for people living with advanced breast cancer. Advanced breast cancer means the cancer has spread from where it first started to other parts of the body, like bones, lungs, or liver. Sometimes, this type of cancer can be difficult to manage with existing treatments.

The main goal of this study is to compare ARV-471 with a medicine called fulvestrant. Fulvestrant is already an approved treatment for breast cancer, but ARV-471 is new. By comparing them, doctors hope to understand if ARV-471 is safe and if it works better or similarly to fulvestrant in helping to control advanced breast cancer.

This research is really important because it could lead to new treatment options for people with advanced breast cancer. Finding more effective and well-tolerated medicines can improve the quality of life and outcomes for patients.

Key takeaways

This study compares a new medicine (ARV-471) with an existing one (fulvestrant) for advanced breast cancer.
It's for people whose cancer has spread and responded to certain hormone therapies, including a CDK4/6 inhibitor.
Participants will either take daily pills of ARV-471 or receive regular injections of fulvestrant.
The treatment continues as long as it's helping and side effects are manageable.
The study aims to find out if ARV-471 is safe and effective.
You can stop participating at any time if you wish.

Who may be eligible?

This study is looking for adults aged 18 or over. You might be suitable if you have breast cancer that has come back in the local area or spread to other parts of your body, and it cannot be completely removed by surgery or radiation. Your cancer also needs to be of a type that responds to hormone therapies, which doctors call 'estrogen receptor positive'. Importantly, you must have already received one type of treatment called a CDK4/6 inhibitor combined with hormone therapy for your advanced cancer.

There are also some reasons why you might not be able to join. For example, if your cancer has spread aggressively to your internal organs and is causing severe symptoms, or if you've already had certain other specific treatments like fulvestrant or other similar new hormone therapies. You also can't take part if you currently have active brain metastases, or if you have serious problems with your liver, kidneys, or bone marrow.

Quick self-check

Are you an adult (18 or older)?
Do you have advanced breast cancer that has spread or come back?
Has your cancer been treated with a CDK4/6 inhibitor with hormone therapy before, for advanced cancer?
Has your cancer type been identified as 'estrogen receptor positive'?
Do you not have severe health issues with your liver, kidneys, or bone marrow?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll be assigned to one of two groups: half of the people will receive the new medicine ARV-471, and the other half will receive fulvestrant. This is decided by chance, like flipping a coin.

If you're in the ARV-471 group, you'll take the medicine by mouth with food once a day. If you're in the fulvestrant group, you'll get injections into your muscles. In the first month, you'll get two injections (one on day 1 and another 2 weeks later). After that, you'll have one injection at the start of each new treatment cycle. Each 'cycle' of treatment lasts 28 days.

You'll continue with your assigned medicine until your breast cancer gets worse, or if you experience side effects that become too difficult to manage. You will have regular visits to the clinic for check-ups and tests to see how you are doing and how the medicine is working. The study team will explain exactly what these visits involve, including blood tests and scans, and how long your participation might last.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to a new medicine not yet widely available, which could potentially help your condition. However, there are also potential risks; new medicines can have side effects that are not fully known, and the treatment might not work for everyone. These side effects can range from mild to severe, and the study team will monitor you closely and explain all known risks. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (312)

California Cancer Associates for Research and Excellence, Inc. (cCARE)
Encinitas, United States
Orange Coast Memorial Medical Center
Fountain Valley, United States
California Cancer Associates for Research and Excellence
Fresno, United States
Providence Queen of the Valley Medical Center
Napa, United States
California Cancer Associates for Research and Excellence
San Marcos, United States
Olive View-UCLA Medical Center
Sylmar, United States
Smilow Cancer Hospital Care Center at Fairfield
Fairfield, United States
Smilow Cancer Hospital at Yale-New Haven
New Haven, United States
Yale-New Haven Hospital
New Haven, United States
Smilow Cancer Hospital Care Center at North Haven
North Haven, United States
Smilow Cancer Hospital Care Center at Trumbull
Trumbull, United States
Florida Cancer Specialists
Altamonte Springs, United States

+300 more sites — see the official record for the full list.

Common questions

What is advanced breast cancer?

Advanced breast cancer means the cancer has spread beyond the breast to nearby areas or further away to other parts of the body like bones, lungs, or liver.

What is ARV-471?

ARV-471 is a new medicine being tested in this study for people with advanced breast cancer. Its aim is to block the growth of cancer cells.

What is fulvestrant?

Fulvestrant is a medicine already used to treat advanced breast cancer by blocking hormones that can help cancer grow.

Will I know if I'm getting the new medicine or the existing one?

No, this is a 'blinded' study, meaning neither you nor your doctor will usually know which medicine you are receiving. This helps make the study results as fair as possible.

How long will I be in the study?

You will receive the study medicine until your breast cancer gets worse or if you experience side effects that are too severe. The study team will discuss the overall duration of follow-up with you.