A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer
This study is for postmenopausal women who have breast cancer that needs continued treatment and has specific features (HR-positive, HER2-negative). Researchers want to see if adding a drug called abemaciclib to standard hormone therapy (like anastrozole or letrozole) is more effective than hormone therapy alone. Participants will be put into groups by chance: two groups will receive abemaciclib plus hormone therapy, and one group will receive a dummy pill (placebo) plus hormone therapy. The goal is to find out if this new combination can improve treatment for this type of breast cancer.
At a glance
What is this study about?
This study is investigating a new way to treat breast cancer in women who have gone through menopause. Specifically, it's for those whose breast cancer is described as 'hormone receptor-positive' (meaning its growth is affected by hormones) and 'HER2-negative' (meaning it doesn't have too much of a certain protein called HER2). This type of breast cancer is common, and hormone therapy is often used to treat it.
The research aims to find out if adding a drug called abemaciclib to standard hormone therapy medicines, such as anastrozole or letrozole, works better than hormone therapy alone. Abemaciclib is a type of medicine that targets certain proteins involved in cancer cell growth. By combining it with hormone therapy, doctors hope to stop the cancer from growing or spreading more effectively.
Participants in the study will be randomly assigned to different treatment groups, like drawing names out of a hat. Some will get the new combination of abemaciclib plus hormone therapy, while others will receive a dummy pill (placebo) along with their hormone therapy. This comparison helps researchers understand if abemaciclib truly makes a difference. The results could potentially lead to new and better treatment options for women with this specific type of breast cancer.
Key takeaways
- This study is for postmenopausal women with specific type of breast cancer (HR+, HER2-).
- It tests combining abemaciclib with standard hormone therapy.
- Participants will receive either abemaciclib + hormone therapy or a placebo + hormone therapy.
- It aims to find better treatments for this breast cancer type.
- Regular check-ups and monitoring will be part of taking part.
Who may be eligible?
This study is for women who have gone through menopause and have been diagnosed with a specific type of breast cancer: one that is hormone receptor-positive and HER2-negative. The cancer should either have returned in the local area or be metastatic (spread to other parts of the body). You would typically need to be in reasonably good health otherwise, able to swallow capsules, and not have certain other serious health issues like inflammatory breast cancer or cancer in the brain.
There are also some reasons why you might not be able to join. For example, if you've recently had certain other breast cancer treatments, especially other drugs that work in a similar way to abemaciclib, or if your cancer is causing very severe symptoms like a 'visceral crisis' (affecting organs badly). You also can't be taking other experimental drugs or have recently received certain bone-strengthening medications.
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 a woman who has gone through menopause?
- Do you have breast cancer that is hormone receptor-positive and HER2-negative?
- Is your breast cancer either locally recurrent (returned nearby) or metastatic (spread)?
- Are you generally well and able to swallow pills?
- Have you not had recent similar treatments or other experimental drugs?
What does participation involve?
If you take part in this study, you'll be randomly assigned to one of two groups: either you'll receive the study drug abemaciclib along with standard hormone therapy, or you'll get a dummy pill (placebo) along with standard hormone therapy. You won't know which group you are in, and neither will the study doctors.
You'll be asked to attend regular clinic visits for examinations, blood tests, and to assess how you're feeling and how the treatment is working. You'll take the study medication as capsules. The total duration of your participation could vary, as you'd continue treatment as long as it's helping and you're not having severe side effects. There would also be follow-up appointments to monitor your health after you stop taking the study medication.
Potential risks and benefits
Locations (155)
- Ironwood Cancer & Research CentersVerified postcodeChandler, United States
- Highlands Oncology GroupVerified postcodeSpringdale, United States
- CBCC Global Research, Inc.Verified postcodeBakersfield, United States
- California Cancer Associates Research and ExcellenceVerified postcodeFresno, United States
- TRIO-US (Translational Research in Oncology-US)Verified postcodeLos Angeles, United States
- Central Coast Medical Oncology CorporationVerified postcodeLos Angeles, United States
- Orlando Health, IncVerified postcodeLos Angeles, United States
- North Valley Hematology/Oncology Medical GroupVerified postcodeLos Angeles, United States
- UCLA Hematology/Oncology - ParksideVerified postcodeSanta Monica, United States
- Holy Cross HospitalVerified postcodeFort Lauderdale, United States
- Lakes Research, LLCVerified postcodeMiami Lakes, United States
- Candler Medical Oncology Practice - StatesboroVerified postcodeSavannah, United States
Common questions
What does 'postmenopausal' mean?
It means you have naturally stopped having periods for at least 12 months, or you have had surgery to remove your ovaries.
What is 'hormone receptor-positive' breast cancer?
This means your cancer cells have receptors that attach to hormones, like oestrogen. These hormones can help the cancer grow, so treatments often aim to block these receptors or reduce hormone levels.
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the study drug but contains no active medicine. It helps researchers fairly compare how well the real drug works.
How long will I be on the study treatment?
You would continue taking the study medication for as long as it's helping control your cancer and you are tolerating it well, without problematic side effects.
Will I know which treatment I am getting?
No, this is a 'blinded' study, meaning neither you nor your study doctor will know if you are receiving abemaciclib or the placebo, until the study is over or in special circumstances.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.