Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
This study is for people with advanced breast cancer that is Estrogen Receptor positive (ER+) and HER2 negative (HER2-), and has a specific gene change called an ESR1 mutation. These cancers have already been treated with certain other therapies (ribociclib or palbociclib-based treatments) and kept growing. Researchers want to see if a combination of drugs called lasofoxifene and abemaciclib works better or has different side effects than another combination, fulvestrant and abemaciclib. Participants will receive one of these two drug combinations. The main goal is to find out which treatment is more effective. This is a Phase 3 study, meaning it's in the later stages of testing new treatments.
At a glance
What is this study about?
This study is looking at a specific type of advanced breast cancer. It's for breast cancer that has spread locally or to other parts of the body (this is called 'locally advanced' or 'metastatic'). The cancer must also be Estrogen Receptor positive (ER+) and HER2 negative (HER2-). What's really key for this study is that the cancer also has a specific genetic change, or 'mutation,' called an ESR1 mutation.
This study is for people whose cancer has continued to grow even after they've already had a specific type of treatment, often involving drugs like ribociclib or palbociclib. The main purpose of the study is to compare two different ways of treating this breast cancer. One group of participants will receive a combination of two drugs: lasofoxifene and abemaciclib. The other group will receive a combination of fulvestrant and abemaciclib. Researchers want to see which of these combinations works better at controlling the cancer and what side effects they might have.
By comparing these two treatments, doctors hope to learn if one is more effective or safer for people with this particular type of breast cancer with the ESR1 mutation. This could help improve future treatments for this condition.
Key takeaways
- This study is for advanced ER+/HER2- breast cancer with a specific genetic change (ESR1 mutation).
- It compares two treatment combinations: lasofoxifene with abemaciclib, versus fulvestrant with abemaciclib.
- You must have already received other specific breast cancer treatments and your cancer has continued to grow.
- Participation involves taking study drugs (pills or injections), and regular check-ups with your medical team.
- The goal is to find more effective treatments for this specific type of breast cancer.
Who may be eligible?
To join this study, you must be an adult (18 or older), either a woman (before or after menopause) or a man. Your breast cancer needs to be locally advanced or have spread to other parts of your body (metastatic), and it must be Estrogen Receptor positive (ER+) and HER2 negative (HER2-).
Your cancer must also show a specific genetic change called an ESR1 mutation. This mutation will be found by testing your blood or a sample of your cancer tissue. You must have already been treated for your advanced breast cancer with a common type of hormone therapy combined with drugs like palbociclib or ribociclib, and your cancer must have continued to grow despite these treatments. However, your cancer should not have progressed on those specific treatments until at least 6 months had passed.
You also need to be generally well enough to participate, as determined by your doctor, and able to swallow tablets. If you've had brain metastases, they must be stable, treated, and not causing symptoms or requiring steroid medication to be eligible.
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), male or female?
- Do you have advanced breast cancer (either locally advanced or metastatic)?
- Is your breast cancer Estrogen Receptor positive (ER+) and HER2 negative (HER2-)?
- Has your breast cancer been tested, and does it have an ESR1 mutation?
- Have you already been treated with a ribociclib- or palbociclib-based therapy for your advanced breast cancer, and the cancer has progressed after that?
- Are you generally well enough to participate, as assessed by a doctor?
What does participation involve?
If you join this study, you will either take a combination of lasofoxifene and abemaciclib, or a combination of fulvestrant and abemaciclib. Both abemaciclib and lasofoxifene are taken as pills by mouth. Fulvestrant is given as an injection into a muscle. Initially, fulvestrant injections are given on specific days (Days 1, 15, and 29) and then once a month after that. Abemaciclib is taken twice a day.
You will have regular doctor visits, blood tests, and scans to check how you are doing, how the treatment is affecting your cancer, and to monitor for any side effects. The exact number of visits and the total length of time you will be in the study will depend on how you respond to the treatment, but you will be followed carefully throughout. You will continue treatment for as long as it is helping you and you are tolerating it well.
Potential risks and benefits
Locations (224)
- Mayo Clinic - ScottsdaleVerified postcodeScottsdale, United States· Recruiting
- University of Arizona - Cancer CenterVerified postcodeTucson, United States· Recruiting
- Providence Medical Foundation - Santa Rosa, CAVerified postcodeSanta Rosa, United States· Recruiting
- Mayo Clinic - JacksonvilleVerified postcodeJacksonville, United States· Recruiting
- Miami Cancer InstituteVerified postcodeMiami, United States· Recruiting
- Miami Cancer Institute PlantationVerified postcodePlantation, United States· Recruiting
- Emory University School of MedicineVerified postcodeAtlanta, United States· Recruiting
- Norton Cancer InstituteVerified postcodeLouisville, United States· Recruiting
- Johns Hopkins Kimmel Cancer CenterVerified postcodeBaltimore, United States· Recruiting
- Massachusetts General HospitalVerified postcodeBoston, United States· Recruiting
- Dana-Farber Cancer InstituteVerified postcodeBoston, United States· Recruiting
- Beth Israel Deaconess Medical CenterVerified postcodeBoston, United States· Recruiting
Common questions
What is an ESR1 mutation?
An ESR1 mutation is a specific change in a gene that can make some breast cancers resistant to certain hormone therapies. This study specifically looks at treatments for cancers with this gene change.
What is meant by 'locally advanced' or 'metastatic' breast cancer?
Locally advanced means the cancer has grown into nearby tissues. Metastatic means the cancer has spread to other parts of the body, away from the original breast, often to bones, liver, or lungs.
Why is this study comparing two different drug combinations?
Researchers want to see if one combination of drugs (lasofoxifene plus abemaciclib) works better or has different effects than another common combination (fulvestrant plus abemaciclib) for your specific type of breast cancer.
What does a 'Phase 3' study mean?
Phase 3 means this is a later stage of research. The treatments have already been tested in smaller groups, and now they are being compared on a larger scale to see if the new approach is better than existing ones.
Will I know which treatment I am receiving?
Often in studies like this, you will be assigned to a treatment group, but you might not know which specific combination you are getting until the study is over, to make sure the results are fair. Your study team can provide more details about this.
How to find out more
Simon Daggett - Senior Vice President, Clinical Operations
Always speak to your GP or specialist before deciding to take part in a study.
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