Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
This clinical trial is testing a new treatment called palazestrant, in combination with an existing drug, ribociclib, for people with advanced breast cancer. This particular type of breast cancer is known as ER-positive and HER2-negative. The study wants to find out if this new combination is more effective and just as safe as the current standard treatment, which uses letrozole and ribociclib. Participants in the study will be adults who have not yet received other systemic treatments for their advanced breast cancer. It's designed to see if the investigational drug can offer an improved option for managing this condition. The study is comparing two groups to understand the benefits and any side effects of the new palazestrant combination.
At a glance
What is this study about?
This study is a clinical trial looking at a new treatment for advanced breast cancer that is ER-positive and HER2-negative. In simpler terms, this means the cancer cells have certain characteristics that allow them to be targeted by specific types of medicine. Advanced breast cancer refers to cancer that has spread beyond the breast or into nearby areas, or has come back after earlier treatment.
The main goal of this study is to compare a new drug called palazestrant, when given alongside a common breast cancer drug called ribociclib, to the current standard treatment which combines letrozole and ribociclib. Doctors want to see if adding palazestrant makes the treatment more effective at controlling the cancer and if it's safe for patients. This is important because finding new and better treatments can improve the lives of people living with advanced breast cancer.
About 1,000 adult patients will take part in this international study. Half of them will receive the new palazestrant combination, and the other half will receive the standard letrozole combination. Participants won't know which treatment they are getting, nor will their doctors. This is done to make sure the results are fair and unbiased. The findings from this study will help doctors decide if palazestrant should become a new standard treatment option in the future.
Key takeaways
- This study evaluates a new combination treatment for advanced ER+/HER2- breast cancer.
- It compares palazestrant plus ribociclib to the standard treatment of letrozole plus ribociclib.
- Participants must have not received prior systemic treatment for their advanced cancer.
- It's a 'blinded' study, meaning you won't know which treatment you receive.
- The goal is to find more effective and safe ways to treat this type of breast cancer.
- You can withdraw from the study at any time without affecting your care.
Who may be eligible?
This study is looking for adult men and women newly diagnosed with advanced breast cancer that is ER-positive and HER2-negative. This means your cancer has certain features that the study drugs aim to target. You might be considered if your cancer has spread to other parts of the body or to nearby areas, and cannot be cured by surgery or other local treatments. Importantly, you should not have received any previous medication treatments for this advanced stage of breast cancer.
You would also need to be generally well enough to take part, meaning you can carry out most daily activities without too much difficulty. Your blood test results for organs like your liver and kidneys also need to be within a healthy range. If you previously had breast cancer and it returned more than a year after finishing hormone therapy (with or without CDK4/6 inhibitors), you might also be eligible. Men and women who haven't gone through menopause will need to take an additional medication to suppress their hormones.
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 an adult (18 or older)?
- Do you have ER-positive, HER2-negative advanced breast cancer?
- Have you *not* had previous medication treatment for your advanced breast cancer?
- Are you generally well and active?
- Are your liver and kidney functions healthy?
- If you are male or pre-menopausal, are you willing to take a specific hormone-blocking medication?
What does participation involve?
If you join this study, you will be randomly assigned to one of two treatment groups, like flipping a coin. You won't know which group you're in, and neither will your doctor, to keep the results fair. You will receive either the new palazestrant combination or the standard letrozole combination, both alongside ribociclib. This will involve taking study medications, likely in pill form.
You will have regular visits to the clinic for check-ups, blood tests, and scans to monitor your health and how your cancer is responding to the treatment. These visits will help the study doctors understand if the medication is working and if there are any side effects. The total duration of your participation will depend on how you respond to the treatment, and you will continue as long as the treatment is helping and you are tolerating it well. There will also be follow-up appointments after you stop taking the study medication to monitor your long-term health.
Potential risks and benefits
Locations (124)
- Clinical Trial SiteVerified postcodeHot Springs, United States· Active not recruiting
- Clinical Trial SiteVerified postcodeBeverly Hills, United States· Active not recruiting
- Clinical Trial SiteVerified postcodeSanta Barbara, United States· Active not recruiting
- Clinical Trial SiteVerified postcodeAurora, United States· Active not recruiting
- Clinical Trial SiteVerified postcodeDenver, United States· Recruiting
- Clinical Trial SiteVerified postcodeHonolulu, United States· Active not recruiting
- Clinical Trial SiteVerified postcodePeoria, United States· Recruiting
- Clinical Trial SiteVerified postcodeAmes, United States· Active not recruiting
- Clinical Trial SiteVerified postcodeScarborough, United States· Recruiting
- Clinical Trial SiteVerified postcodeAnnapolis, United States· Active not recruiting
- Clinical Trial SiteVerified postcodeMinneapolis, United States· Recruiting
- Clinical Trial SiteVerified postcodeKansas City, United States· Recruiting
Common questions
What kind of breast cancer is this study for?
This study is for advanced breast cancer that is ER-positive and HER2-negative, meaning it has specific features that the study drugs aim to target.
What new drug is being tested?
The study is testing a new drug called palazestrant, in combination with an existing treatment, ribociclib.
Will I know which treatment I'm getting?
No, neither you nor your doctor will know which treatment you are receiving. This is to ensure the study results are fair.
Can I join if I've already had treatment for my advanced breast cancer?
No, this study is for people who have not yet received *systemic* anti-cancer treatment for their advanced breast cancer.
What if I experience side effects?
Your health will be closely monitored, and your medical team will address any side effects you might experience during the study.
How to find out more
Olema Pharmaceuticals, Inc.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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