RecruitingPHASE3INTERVENTIONAL

OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

This important Phase 3 study is looking at a new medicine, palazestrant (also known as OP-1250), for people with advanced, ER-positive, HER2-negative breast cancer. This type of cancer responds to hormones, but in this study, it would have already grown even after a common type of hormone therapy combined with another drug called a CDK4/6 inhibitor. The study aims to find out if palazestrant is safer and works better than existing standard treatments like fulvestrant or other hormone therapies (such as anastrozole, letrozole, or exemestane). Researchers want to see if palazestrant can help control the cancer for longer and improve quality of life for patients.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Olema Pharmaceuticals, Inc.

Enrolment target

510

Start

16 Nov 2023

Estimated completion

30 Sep 2027

Breast Cancer Advanced Breast Cancer Metastatic Breast Cancer ER Positive Breast Cancer HER2 Negative Breast Carcinoma

What is this study about?

This study is a Phase 3 clinical trial, which means it's a large and important step in testing a new medicine. Researchers want to compare a new drug called palazestrant (or OP-1250) with treatments doctors currently use for a specific type of breast cancer. This type is known as ER-positive and HER2-negative, which means the cancer cells have receptors that respond to hormones but don't have too much of a protein called HER2. This is the most common kind of breast cancer.

The study focuses on patients whose cancer has grown or returned after they've already had one type of hormone therapy combined with another common cancer drug called a CDK4/6 inhibitor. This means their cancer has become more difficult to treat, and new options are needed. By comparing palazestrant to standard medicines like fulvestrant or other hormone therapies (anastrozole, letrozole, or exemestane), the researchers hope to find a new, more effective, or safer way to treat this challenging stage of breast cancer.

Taking part in a study like this helps doctors learn more about cancer and how to treat it. If palazestrant proves to be safe and effective, it could become a new treatment option for many people in the future. The study will involve giving some participants palazestrant and others one of the standard treatments, then carefully watching to see how everyone responds.

Key takeaways

New drug called palazestrant being tested.
Compares palazestrant to standard hormone therapies.
For advanced ER-positive, HER2-negative breast cancer.
Patients must have had prior hormone therapy with a CDK4/6 inhibitor.
Aims to find safer and more effective treatment options.
Participation involves regular clinic visits and monitoring.

Who may be eligible?

This study is open to adult men and women who have advanced breast cancer that is ER-positive and HER2-negative. This means your cancer has spread or is locally advanced and can't be cured with current treatments. Crucially, your cancer must have grown or come back after you've already had hormone therapy alongside a CDK4/6 inhibitor.

You'll need to be generally well enough to take part, with normal organ function. You shouldn't have active serious symptoms from your cancer, like sudden organ damage or a severe heart condition. Also, you cannot have received chemotherapy for your advanced cancer in the past, or have been treated with a similar drug called elacestrant.

If you're a man or a woman who hasn't gone through menopause, you'll need to be willing to take another medicine (a GnRH or LHRH agonist) as part of your treatment. Your doctors will check all these details carefully to make sure the study is a safe and suitable option for you.

Quick self-check

Are you an adult man or woman?
Do you have advanced breast cancer that is ER-positive and HER2-negative?
Has your cancer grown or returned after hormone therapy plus a CDK4/6 inhibitor?
Are you generally well and able to perform daily activities?
Have you NOT had chemotherapy for your advanced cancer?
Do you NOT have severe symptoms from your cancer affecting vital organs?

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 either receive the new drug, palazestrant, or one of the standard hormone therapies currently used for breast cancer. The specific treatment you receive will be decided randomly, like flipping a coin. You'll have regular visits to the clinic for check-ups, blood tests, and scans to monitor your health and how the treatment is working. This will help doctors understand the effects of the new drug compared to existing treatments. You will continue treatment and follow-up until your cancer gets worse, or you experience side effects that make continuing difficult, or you choose to stop. The total duration of participation varies depending on how long the treatment works for you.

Potential risks and benefits

Taking part in this study could offer some potential benefits, such as access to a new treatment (palazestrant) before it's widely available, or closer monitoring of your health. However, there are also potential risks, as with any medical treatment. The new drug might cause side effects, or it might not work as well as expected. All the treatments in this study have potential risks, and your study doctor will explain these to you in detail. Remember, you can choose to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (233)

Clinical Trial Site
Tucson, United States· Recruiting
Clinical Trial Site
Fountain Valley, United States· Not yet recruiting
Clinical Trial Site
Glendale, United States· Not yet recruiting
Clinical Trial Site
La Jolla, United States· Completed
Clinical Trial Site
Los Alamitos, United States· Recruiting
Clinical Trial Site
Los Angeles, United States· Recruiting
Clinical Trial Site
Whittier, United States· Recruiting
Clinical Trial Site
Aurora, United States· Recruiting
Clinical Trial Site
Denver, United States· Recruiting
Clinical Trial Site
Golden, United States· Recruiting
Clinical Trial Site
Grand Junction, United States· Active not recruiting
Clinical Trial Site
Danbury, United States· Recruiting

+221 more sites — see the official record for the full list.

Common questions

What kind of cancer is this study for?

It's for advanced breast cancer that is ER-positive and HER2-negative, and has grown or returned after previous hormone therapy with a CDK4/6 inhibitor.

What is palazestrant?

Palazestrant is a new medicine being tested in this study to see if it's more effective or safer than existing standard treatments for this type of breast cancer.

Will I definitely get the new drug?

No, you might receive palazestrant or one of the standard hormone therapies. The treatment you get will be chosen randomly.

What does 'Phase 3' mean?

Phase 3 means this is a large, important study designed to confirm if the new drug is safe and effective compared to existing treatments, before it can be approved for wider use.

What if I experience side effects?

The study team will closely monitor you for any side effects, and you'll have regular medical support. You can withdraw from the study at any time if needed.

How to find out more

Olema Pharmaceuticals, Inc.

OPERA-01@olema.com 415-651-7206 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.