Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer
This study is looking at a new drug called elacestrant when given alongside other well-known breast cancer medications. It's for individuals with advanced breast cancer that has spread, specifically a type known as ER+/HER2-. The study has two main parts. The first part aims to find the safest and most effective dose of elacestrant when combined with each of the other drugs. The second part will then check how well these combinations work and if they are safe for more people. The overall goal is to find new and better ways to treat this type of breast cancer, hoping to improve outcomes for patients.
At a glance
What is this study about?
This study is looking into new ways to treat advanced breast cancer that has spread to other parts of the body. This specific type of breast cancer is called ER+/HER2- (oestrogen receptor positive/human epidermal growth factor receptor 2 negative). This means the cancer cells grow in response to the hormone oestrogen, but they don't have too much of a protein called HER2.
The main focus is a new drug called elacestrant, which is being tested in combination with several other established breast cancer drugs like alpelisib, everolimus, ribociclib, palbociclib, capivasertib, and abemaciclib. The study is divided into two main stages. The first stage, called Phase 1b, is about finding the best and safest dose of elacestrant when it's given with each of these other drugs. Researchers will closely watch for any side effects at different doses to make sure the combination is well-tolerated.
Once the best doses are found, the second stage, called Phase 2, will involve more people. In this stage, the researchers will check how well these drug combinations work together to slow down or shrink the cancer, and they will continue to monitor their safety. By testing these combinations, the study hopes to find more effective treatments for people living with this type of advanced breast cancer.
Key takeaways
- Tests new drug elacestrant with existing breast cancer medicines.
- Aimed at advanced, spreading ER+/HER2- breast cancer.
- First, finds the safest dose; then, checks if it works.
- Open to both men and women over 18.
- May offer access to new treatments, but comes with potential risks.
- You can stop participating at any time.
Who may be eligible?
To join this study, participants must be at least 18 years old. This study includes both women and men. Women of any menopausal status can participate, but if you are premenopausal or perimenopausal, you'll need to be taking a specific hormone therapy (LHRH agonist) before and during the study.
Your breast cancer must be a specific type: ER+ (oestrogen receptor positive) and HER2- (human epidermal growth factor receptor 2 negative), and it must have spread. Doctors will need to confirm that your cancer has recently gotten worse even with current treatments. You'll also need to have at least one part of your cancer that can be easily measured on scans.
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 breast cancer that has spread?
- Has your doctor confirmed your cancer is ER+ (oestrogen receptor positive) and HER2- (human epidermal growth factor receptor 2 negative)?
- Has your cancer recently gotten worse while on treatment?
- If you are premenopausal or perimenopausal, are you taking a specific hormone therapy (LHRH agonist)?
What does participation involve?
Taking part in this study would involve regular visits to the clinic for assessments and to receive medication. You would receive one of the combinations of elacestrant and another anti-cancer drug. Doctors and nurses will check your health, monitor your cancer with scans, and keep a close eye on any side effects you might experience. The first part of the study involves finding the right dose, which means close monitoring. The second part will then test the effectiveness and safety on more participants over a longer period.
Potential risks and benefits
Locations (118)
- Dothan Hematology and OncologyVerified postcodeDothan, United States· Recruiting
- Mayo Clinic - ArizonaVerified postcodePhoenix, United States· Recruiting
- Highlands Oncology GroupVerified postcodeSpringdale, United States· Recruiting
- OPN Healthcare (Arcadia Location)Verified postcodeArcadia, United States· Withdrawn
- City of Hope National Medical CenterVerified postcodeDuarte, United States· Not yet recruiting
- Glendale AdventistVerified postcodeGlendale, United States· Withdrawn
- OPN Healthcare (Los Alamitos Location)Verified postcodeLos Alamitos, United States· Recruiting
- Cedars SinaiVerified postcodeLos Angeles, United States· Recruiting
- UCLA UCLA Hem/Onc - Clinical Research UnitVerified postcodeLos Angeles, United States· Recruiting
- UCSF Helen Diller Family Comprehensive Cancer CenterVerified postcodeSan Francisco, United States· Recruiting
- TOI Clinical ResearchVerified postcodeWhittier, United States· Completed
- Rocky Mountain Cancer CentersVerified postcodeLone Tree, United States· Recruiting
Common questions
What type of breast cancer is this study for?
It's for advanced breast cancer that has spread, specifically the ER+/HER2- type.
What drugs are being tested?
A new drug called elacestrant is being tested with other established breast cancer medicines like alpelisib, everolimus, ribociclib, palbociclib, capivasertib, and abemaciclib.
What are the main goals of the study?
To find the safest dose of these drug combinations and to see how well they work against the cancer.
Are men allowed to participate?
Yes, both women and men who meet the other criteria can join the study.
What happens if I want to stop participating?
You can leave the study at any time without it affecting your medical care.
How to find out more
Stemline Trials
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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