A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
This study is looking into a new medication called camizestrant for early breast cancer that is sensitive to hormones (ER+/HER2-). It’s for people who have already finished their main treatments like surgery and some initial hormone therapy, and whose cancer has an intermediate or high chance of returning. We want to find out if camizestrant can reduce the risk of the cancer coming back more effectively than current standard hormone therapies like Tamoxifen, Anastrozole, Letrozole, or Exemestane. Participants will take medication for five years, and researchers will follow their health for up to ten years to see how well camizestrant works and if it's safe.
At a glance
What is this study about?
This study is a ‘Phase 3’ trial, meaning it's one of the final steps in testing a new drug. The drug being studied is called camizestrant. It's designed for people who have already completed their main treatments for early breast cancer, such as surgery (and sometimes chemotherapy), and have also had two to five years of standard hormone therapy. The specific type of breast cancer this study focuses on is called ER+/HER2- breast cancer, which means the cancer cells grow in response to hormones, but don't have high levels of a protein called HER2.
The main goal of the study is to see if camizestrant is better than the standard hormone treatments at preventing the breast cancer from returning. Researchers are especially interested in people whose cancer has an intermediate or high chance of coming back. Participants will be taking either camizestrant or a standard hormone therapy for five years. This will help doctors understand if camizestrant can offer a new and more effective treatment option for this group of patients.
Over the next ten years, researchers will carefully monitor participants. They will look at several important things, including whether the cancer comes back, if it spreads to other parts of the body, and how long people live. They will also look closely at any side effects to make sure camizestrant is safe. The results of this study could help improve future treatments for early breast cancer.
Key takeaways
- Tests a new drug (camizestrant) for early, hormone-sensitive breast cancer.
- Aims to reduce the risk of cancer returning after initial treatments.
- Involves taking medication for 5 years, with up to 10 years of health follow-up.
- Compares camizestrant to standard hormone therapies.
- For those who have already completed 2-5 years of hormone therapy.
- Participants may receive either the new drug or a standard treatment.
Who may be eligible?
To join this study, you need to be at least 18 years old, male or female, and have been diagnosed with early breast cancer that is hormone-sensitive (ER+/HER2-). Your cancer should have an intermediate or high chance of coming back. You must have already completed your main treatments like surgery, with or without chemotherapy, and have taken hormone therapy for at least two years but no more than five years.
There are also some important health checks; your general health needs to be good, and your organs should be working well. This ensures that taking part in the study would be safe for you. The research team will carefully check all your medical details to confirm you meet these requirements.
Some reasons you wouldn't be able to join include if your breast cancer has spread to other parts of your body, or if you have had certain other cancers recently. If you are pregnant or breastfeeding, or if you've already had certain similar experimental drugs, you also wouldn't be able to participate. The study staff will discuss all these points with you in detail.
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 early breast cancer that is ER+/HER2-?
- Have you finished your main breast cancer treatments (like surgery)?
- Have you taken hormone therapy for your breast cancer for 2 to 5 years already?
- Is your general health good?
- Is your breast cancer considered at intermediate or high risk of coming back?
What does participation involve?
If you decide to take part, you'll be given either the new drug camizestrant or one of the standard hormone therapies (like Tamoxifen, Anastrozole, Letrozole, or Exemestane). You will take this medication for five years. Throughout this period, you’ll have regular appointments at the hospital or clinic for check-ups, where doctors will monitor your health, perform tests, and ask how you’re feeling. These visits are important for understanding how the treatment is working and checking for any side effects.
After you finish the five years of medication, the study team will continue to follow your health for another five years, making the total follow-up period up to ten years. During this time, you'll still have occasional check-ups, though likely less often than during the treatment phase. This long-term follow-up helps researchers understand the full effect of the treatment over many years. All the details about visits, tests, and medication will be fully explained to you by the study team.
Potential risks and benefits
Locations (711)
- Research SiteVerified postcodeBirmingham, United States· Active not recruiting
- Research SiteVerified postcodeDothan, United States· Active not recruiting
- Research SiteVerified postcodeAnchorage, United States· Active not recruiting
- Research SiteVerified postcodeChandler, United States· Active not recruiting
- Research SiteVerified postcodeHot Springs, United States· Active not recruiting
- Research SiteVerified postcodeAnaheim, United States· Active not recruiting
- Research SiteVerified postcodeBeverly Hills, United States· Active not recruiting
- Research SiteVerified postcodeConcord, United States· Active not recruiting
- Research SiteVerified postcodeCorona, United States· Active not recruiting
- Research SiteVerified postcodeFountain Valley, United States· Active not recruiting
- Research SiteVerified postcodeGreenbrae, United States· Active not recruiting
- Research SiteVerified postcodeLos Alamitos, United States· Active not recruiting
Common questions
What type of breast cancer is this study for?
This study is for early breast cancer that is hormone-sensitive (ER+/HER2-). This means its growth is linked to hormones, but not the HER2 protein.
How long will I take the study medication?
You will take the study medication for five years.
What happens after I finish the medication?
After you finish the medication, the study team will continue to follow up on your health for up to another five years, making it a total of ten years of follow-up.
Will I definitely get the new drug camizestrant?
You will be given either camizestrant or one of the standard hormone treatments. You won't know which one you are getting at the start, as this is how the study is designed.
Can I stop participating if I want to?
Yes, you can choose to leave the study at any time, and it will not affect your regular medical care.
How to find out more
AstraZeneca Clinical Study Information Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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