RecruitingPHASE2INTERVENTIONAL

Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)

This research study, called MK-6482-029/LITESPARK-029, is looking into a new way to treat metastatic breast cancer that is hormone-sensitive (ER+) and HER2-negative. This means the cancer has spread and responds to hormones. The study is comparing a new treatment combination — belzutifan plus fulvestrant — with a standard treatment, which is everolimus alongside another hormone therapy (either fulvestrant or exemestane). Doctors want to find out how well the new combination works and if it's safe for people whose cancer is advanced and can't be removed by surgery. There's no set goal to prove one treatment is definitely better; instead, it's about understanding the effects of the new combination.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

120

Start

27 Nov 2024

Estimated completion

25 Dec 2028

Metastatic Breast Cancer

What is this study about?

This study is for adults who have breast cancer that has spread to other parts of the body (metastatic disease) and can't be cured by surgery. Specifically, it's for a type of breast cancer that is 'estrogen receptor-positive' (ER+) and 'HER2-negative'. This means the cancer cells use the hormone oestrogen to grow, and they don't have too much of a protein called HER2.

The main idea is to test a new drug called belzutifan when given with fulvestrant, which is a type of hormone therapy already used for breast cancer. They're comparing this new combination against a standard treatment option which involves another drug called everolimus, given with a hormone therapy like fulvestrant or exemestane. The researchers want to see if the new combination is good at fighting the cancer and if it has acceptable side effects.

It's important to know that this is a 'Phase 2' study. This means it's still relatively early in the testing process for this specific combination. They are not trying to prove that one treatment is definitely better than another yet, but rather to gather more information about how effective and safe this new treatment approach might be.

Key takeaways

Tests a new combination treatment for advanced, hormone-sensitive breast cancer.
Compares belzutifan + fulvestrant against standard hormone therapy + everolimus.
Participation involves regular hospital visits for treatment and check-ups.
It's a Phase 2 study, focusing on safety and how well the treatment works.
You can stop participating at any time if you choose to.
Offers a chance to access a new treatment that is not yet widely available.

Who may be eligible?

To be able to take part in this study, you need to meet certain conditions. Your breast cancer must be advanced, meaning it has spread and surgery can't cure it, and it needs to be the ER+ and HER2- type. The doctors will also need to see that your cancer has started to grow again despite previous hormone therapy, especially if you've had a type of drug called a CDK4/6 inhibitor.

You also need to be generally well enough to take part, as assessed by your doctor (they use a simple scale called ECOG performance status where 0 or 1 is good). Any side effects from your previous treatments should have mostly gone away. There are also specific rules about things like liver health and hepatitis B for your safety.

On the other hand, you can't join if your breast cancer could still be cured by surgery, or if you can't take the standard hormone therapies used in the study. You also wouldn't be suitable if you have serious problems swallowing medicines or if your tummy or gut issues would stop you from absorbing the study drugs properly.

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.

Is my breast cancer advanced (metastatic) and not curable by surgery?
Is my breast cancer ER+ and HER2-?
Has my cancer grown despite previous hormone therapy, especially with a CDK4/6 inhibitor?
Am I generally well enough to take part (ECOG performance status 0 or 1)?
Can I swallow oral medications and absorb them properly?
Have I recovered from most side effects of previous treatments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to receive one of two treatment combinations. This means you won't choose which treatment you get, it's like flipping a coin. You'll receive either belzutifan alongside fulvestrant, or everolimus with another hormone therapy (either fulvestrant or exemestane). All these medications are given either as tablets you swallow or injections.

Your involvement will include regular visits to the hospital for assessments. These will involve physical exams, blood tests, and scans to see how the treatment is working and to check for any side effects. These visits will continue for as long as the treatment is helping you and is safe to take, or until you choose to stop. Even after you stop the main treatment, there will be follow-up calls or visits to see how you are doing in the long term. The total length of the study for each person will vary depending on how long they receive treatment and their follow-up.

Potential risks and benefits

Taking part in a clinical trial could offer a chance to try a new treatment that isn't widely available yet, which might help your cancer when standard treatments haven't worked or are no longer effective. However, there are no guarantees that the new treatment will work for everyone, and it might not be better than existing treatments. Like all medicines, the study drugs can cause side effects, some of which could be serious. The study team will monitor you closely for any problems. You will be given full details of potential side effects before you decide to join. Remember, taking part is completely voluntary, and you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (41)

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

City of Hope - Phoenix ( Site 0006)
Verified postcode
Goodyear, United States· Recruiting
Cedars Sinai Medical Center ( Site 0012)
Verified postcode
Beverly Hills, United States· Recruiting
Moores Cancer Center at UC San Diego Health ( Site 0025)
Verified postcode
La Jolla, United States· Recruiting
USC/Norris Comprehensive Cancer Center ( Site 0013)
Verified postcode
Los Angeles, United States· Active not recruiting
USC Norris Oncology Hematology Newport Beach ( Site 0029)
Verified postcode
Newport Beach, United States· Recruiting
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0011)
Verified postcode
Marietta, United States· Completed
Southeastern Regional Medical Center ( Site 0010)
Verified postcode
Newnan, United States· Completed
CHRISTUS Highland ( Site 0005)
Verified postcode
Shreveport, United States· Completed
Renown Regional Medical Center ( Site 0018)
Verified postcode
Reno, United States· Recruiting
MD Anderson Cancer Center at Cooper ( Site 0024)
Verified postcode
Camden, United States· Recruiting
MD Anderson ( Site 0015)
Verified postcode
Houston, United States· Recruiting
Mays Cancer Center ( Site 0022)
Verified postcode
San Antonio, United States· Recruiting

Common questions

What does 'ER+/HER2-' mean?

It means your breast cancer cells have 'estrogen receptors' (they use the hormone oestrogen to grow) but do not have too much of a protein called HER2.

What is a 'clinical trial'?

It's a research study that tests new ways to prevent, detect, or treat diseases like cancer to see if they are safe and effective.

What does 'metastatic breast cancer' mean?

This means the breast cancer cells have spread from the breast to other parts of the body.

Will I get the new drug or the standard treatment?

You will be randomly assigned to one of the two treatment groups, so you won't choose which treatment you receive.

Can I stop participating if I want to?

Yes, you can choose to leave the study at any time, and it won't affect your regular medical care.

How to find out more

Toll Free Number

trialsites@msd.com 1-888-577-8839 Official trial record

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