I3Y-MC-JPCG: A Randomized, Open-Label, Phase 2 Study of Abemaciclib Plus Tamoxifen or Abemaciclib Alone, in Women With Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer
This clinical trial is testing a targeted cancer drug called abemaciclib (also known as Verzenios) for women living with advanced or metastatic breast cancer. The trial focuses on a common type of breast cancer that is hormone receptor-positive and HER2-negative, meaning the cancer cells use hormones like oestrogen to grow. Doctors want to find out whether taking abemaciclib on its own or taking it together with tamoxifen (a well-known hormone therapy) is more effective. The study looks at how long the treatments can keep the cancer stable without it getting worse, and whether the tumours shrink. Women aged 18 and over who have already had treatment for their cancer may be able to take part. Researchers will monitor participants closely over up to 21 months to check how well the medicines work and record any side effects.
At a glance
What is this study about?
Breast cancer is the most common cancer in the UK. In some cases, cancer cells spread from the breast to other parts of the body. When this happens, doctors call it secondary or metastatic breast cancer. Many of these cancers are hormone receptor-positive, which means hormones such as oestrogen help the cancer cells grow. Standard treatments often include hormone therapies like tamoxifen, which block these signals.
This study tests a newer targeted medicine called abemaciclib (brand name Verzenios). Abemaciclib works inside cancer cells by blocking specific proteins that help the cells divide and multiply. Doctors want to see whether combining abemaciclib with tamoxifen works better than using abemaciclib by itself, particularly in women whose cancer has already been treated with other therapies.
During the trial, researchers will measure how long patients live without their cancer growing or spreading further. They will also look at whether the tumours shrink. Finding new, effective ways to control metastatic breast cancer helps give people more treatment options and can improve quality of life.
Key takeaways
- Phase 2 clinical trial testing abemaciclib alone or combined with tamoxifen.
- Aimed at women with HR-positive, HER2-negative metastatic breast cancer.
- Participants take daily tablets at home and attend clinic visits for monitoring.
- The study tracks how well the treatment controls tumour growth for up to 21 months.
- Taking part is voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is designed for adult women who have advanced or metastatic breast cancer. To join, a person's cancer must be hormone receptor-positive (HR-positive) and HER2-negative. This means the cancer cells respond to hormones, but do not have high levels of the HER2 protein.
Participants must have already received prior treatment for their cancer that is no longer working as well as needed. You must be aged 18 or older to take part.
Because this is an open-label, targeted trial, certain medical conditions, recent treatments, or general health issues may mean a person cannot take part. Your hospital doctor or the study team will carry out tests to make sure the trial is safe and appropriate for you.
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.
- You are female and aged 18 or older.
- You have been diagnosed with secondary or metastatic breast cancer.
- Your cancer is hormone receptor-positive (HR+) and HER2-negative.
- You have previously received treatment for your breast cancer.
- You are able to swallow tablets.
What does participation involve?
If you take part, you will be placed into one of two groups. One group will take abemaciclib tablets on their own, while the other group will take abemaciclib tablets alongside tamoxifen tablets. Both medicines are taken by mouth at home.
You will need to visit the hospital clinic regularly for check-ups. During these visits, doctors will run blood tests, check your overall health, and ask about any symptoms or side effects. You will also have regular scans (such as CT or MRI scans) to see whether your tumours are shrinking or staying the same.
Your participation may last for up to 21 months, or for as long as the treatment continues to help you without causing severe side effects. You will also have follow-up contact with the research team to monitor your health over time.
Potential risks and benefits
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Common questions
What is abemaciclib?
Abemaciclib (Verzenios) is a targeted cancer medicine taken as a tablet. It works by blocking proteins that help cancer cells divide and grow.
Will I know which treatment I am receiving?
Yes. This is an 'open-label' study, which means both you and your doctor will know whether you are taking abemaciclib alone or with tamoxifen.
Do I have to pay to take part in the trial?
No. The trial medicines and study tests are provided free of charge, and some trials help with travel expenses to hospital appointments.
Can I leave the study if I change my mind?
Yes. You are free to withdraw from the trial at any point, and your normal medical care will continue as usual.
How often will I need hospital scans?
You will have regular scans every few months so the study team can check if the cancer is responding to the tablets.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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