Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer
This study is investigating a new treatment approach for a specific type of early-stage breast cancer that has been removed by surgery. It focuses on a drug called abemaciclib, which is given in addition to the usual hormone therapy. Doctors want to find out if adding abemaciclib is safe and effective in preventing the cancer from returning, particularly in patients whose breast cancer is considered to be at a higher risk of coming back. The breast cancer must be hormone receptor positive (HR+) and HER2 negative (HER2-), and new to the patient. This is a phase 3 study, meaning it's a larger trial aiming to confirm earlier findings and compare the new treatment with existing options.
At a glance
What is this study about?
This research study is for people who have had surgery for a certain type of early-stage breast cancer. This cancer is described as **hormone receptor positive (HR+)** and **HER2 negative (HER2-)**, which means its growth is linked to hormones, but it doesn't have too much of a protein called HER2. The study is looking at whether adding a drug called abemaciclib to the standard hormone therapy you'd normally receive after surgery can help stop the cancer from coming back.
We already know that hormone therapy after surgery can reduce the risk of breast cancer returning. However, for some people, the risk is still higher. This study aims to see if abemaciclib, when given alongside hormone therapy, can further lower this risk and improve the chances of long-term health. Think of it like adding an extra layer of protection.
The main goal is to check if abemaciclib is both safe to use and effective in preventing the cancer from returning in patients with these specific, higher-risk features. The information from this study will help doctors understand if this combination treatment could become a new standard option for people with this type of breast cancer.
Key takeaways
- This study evaluates abemaciclib with hormone therapy after surgery for specific early-stage breast cancer.
- It's for HR+, HER2- breast cancer with high-risk features.
- The aim is to reduce the chance of the cancer coming back.
- Participation involves taking medication and regular check-ups.
- You might receive abemaciclib + hormone therapy or hormone therapy alone.
- You can stop participating at any time.
Who may be eligible?
This study is looking for both men and women, aged 18 or older. To be considered, you must have had surgery for early-stage breast cancer that is hormone receptor positive (HR+) and HER2 negative (HER2-). It's important that your cancer has not spread to other parts of your body.
Your breast cancer must also be considered 'high-risk,' meaning there's a greater chance of it returning. This could be due to factors like having four or more affected lymph nodes, a larger tumor size (at least 5cm), a high-grade tumor, or a certain level of a marker called Ki-67. You must also have recovered well from any previous treatments like chemotherapy or surgery.
There are also reasons why you might not be able to join. For instance, if your cancer has already spread, if you have inflammatory breast cancer, or if you have a history of certain other breast cancers. You also need to be able to swallow tablets and have generally good health and organ function.
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?
- Have you had surgery for early-stage breast cancer that is HR+ and HER2-?
- Did your breast cancer have features that put it at higher risk of returning (e.g., several lymph nodes affected, larger tumour, high grade)?
- Have you recovered well from your surgery and any other recent treatments?
- Do you not have cancer spread to other parts of your body?
- Are you able to swallow tablets?
What does participation involve?
If you join this study, you would be taking either the study drug, abemaciclib, along with standard hormone therapy, or just standard hormone therapy alone, after your breast cancer surgery. The exact schedule for taking the medication will be explained fully by the study team.
Throughout the study, you'll have regular hospital visits for health checks, blood tests, and to make sure you're doing well and that the treatment is working as expected. These visits are important for monitoring your progress and any potential side effects. The study will last for a certain period, and even after you stop taking the study medication, there will be follow-up appointments to track your long-term health.
More detailed information about visit frequency, tests, and the total length of your involvement will be provided by the study team, tailored to your specific situation.
Potential risks and benefits
Locations (619)
- University of Alabama BirminghamVerified postcodeBirmingham, United States
- Providence Alaska Medical CenterVerified postcodeAnchorage, United States
- Banner MD Anderson Cancer CenterVerified postcodeGilbert, United States
- Arizona Oncology Associates, P.C. - HOPEVerified postcodeGoodyear, United States
- St. Joseph's Hospital and Medical CenterVerified postcodePhoenix, United States
- Mayo Clinic HospitalVerified postcodePhoenix, United States
- The University of Arizona Cancer CenterVerified postcodeTucson, United States
- Yuma Regional Cancer CenterVerified postcodeYuma, United States
- St. Bernards Medical CenterVerified postcodeJonesboro, United States
- Highlands Oncology GroupVerified postcodeSpringdale, United States
- Beverly Hills Cancer CenterVerified postcodeBeverly Hills, United States
- Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical CenterVerified postcodeBurbank, United States
Common questions
What type of breast cancer is this study for?
This study is for early-stage breast cancer that is Hormone Receptor Positive (HR+) and HER2 Negative (HER2-), and has been removed by surgery. It's for people whose cancer is considered 'high-risk' for returning.
What is abemaciclib?
Abemaciclib is a medication being studied to see if it can help prevent breast cancer from coming back when given alongside standard hormone therapy after surgery.
Will I definitely receive abemaciclib if I join?
No, you might receive abemaciclib plus standard hormone therapy, or you might receive standard hormone therapy alone. This is decided by chance (randomly) to fairly compare the treatments.
How long will I be in the study?
The study involves taking the medication for a specified period, typically two years, followed by a longer period of regular check-ups to monitor your health and how well the treatment worked in the long term.
Can I stop participating if I change my mind?
Yes, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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