Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)
This study, called CAPItello-292, is exploring a new combination of medicines for advanced or metastatic breast cancer that is hormone receptor-positive and HER2-negative. This type of breast cancer grows in response to hormones. The study aims to see if adding a new drug called capivasertib to existing treatments (CDK4/6 inhibitors and fulvestrant) can work better than the standard combination alone. The first part of the study will find the safest dose of the new combination. The main part will then compare this new three-drug combination against the two-drug combination already in use, to see if it's more effective and safe for patients. This research is important for finding better ways to treat this specific type of breast cancer.
At a glance
What is this study about?
This study, called CAPItello-292, is specifically designed for people with breast cancer that has spread to other parts of the body (metastatic) or is locally advanced and can't be removed with surgery. This type of breast cancer is also 'hormone receptor-positive and HER2-negative', which means its growth is often influenced by hormones, but it doesn't have too much of a protein called HER2.
The main goal of this study is to see if a new drug called capivasertib, when combined with two other established drugs (a CDK4/6 inhibitor like palbociclib, ribociclib, or abemaciclib, and fulvestrant), works better than the standard two-drug combination without capivasertib. Researchers want to understand if this new three-drug approach can slow down the cancer's growth more effectively and safely.
First, there's a small initial phase (called Phase Ib) to carefully figure out the best and safest dose of the three-drug combination. Once that's determined, the main part of the study (Phase III) will begin. In this phase, some patients will receive the new three-drug combination, while others will receive the standard two-drug combination. This comparison will help doctors understand if adding capivasertib offers a significant benefit for patients with this form of breast cancer.
Key takeaways
- This study is for advanced hormone receptor-positive, HER2-negative breast cancer.
- It tests adding a new drug, capivasertib, to an existing two-drug treatment.
- The goal is to find a more effective and safe treatment option.
- Participation involves regular clinic visits, tests, and providing samples.
- Your doctor will discuss all potential benefits and risks with you.
- You can stop participating at any time.
Who may be eligible?
To join this study, you would need to be an adult (18 to 99 years old), male or female, and have breast cancer that has been confirmed as hormone receptor-positive and HER2-negative. This can be breast cancer that has spread or is advanced and can't be operated on.
You would also need to be a good candidate for the existing medications (fulvestrant and certain CDK4/6 inhibitors like palbociclib, ribociclib, or abemaciclib), as decided by your doctor. Your body's organs and blood counts would need to be working well. For the main part of the study, you would have already received some hormone therapy in the past, and your cancer would have either returned or progressed within a year of that treatment. You would also need to have areas of cancer that can be measured or seen on scans.
There are also some reasons why you might not be able to join. For example, if you've had another cancer recently (unless it was treated a long time ago and cured with low risk of coming back), or if you've had radiation therapy very recently, you might not be eligible. Your study doctor will go through all the detailed requirements with 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.
- Are you an adult (18-99 years old)?
- Have you been diagnosed with breast cancer that is hormone receptor-positive and HER2-negative?
- Has your breast cancer spread or is it locally advanced and unable to be removed by surgery?
- Are your major organs (like your liver and kidneys) working well?
- Are you able to take fulvestrant and certain CDK4/6 inhibitor medications?
- Have you previously received hormone therapy for your breast cancer?
What does participation involve?
If you decide to take part in this study, you would receive the study drugs as either a three-drug combination (capivasertib, a CDK4/6 inhibitor, and fulvestrant) or a two-drug combination (a CDK4/6 inhibitor and fulvestrant). The specific drugs and how often you take them would be explained to you.
Before you start, you'll have some tests, including blood tests and scans, to make sure you're a good fit and to get a baseline picture of your health and cancer. During the study, you'll have regular visits to the clinic for more tests, including blood tests, physical examinations, and scans (like CT or MRI). These tests will help the doctors monitor how you're responding to the treatment and check for any side effects. You'll also need to provide tumor and blood samples at certain times.
The length of your participation would depend on how you respond to the treatment and if you experience any side effects. You would continue treatment for as long as it is working for you and you are tolerating it well. After you stop treatment, there would be a follow-up period to continue monitoring your health.
Potential risks and benefits
Locations (284)
- Research SiteVerified postcodeTucson, United States· Recruiting
- Research SiteVerified postcodeFountain Valley, United States· Recruiting
- Research SiteVerified postcodeGlendale, United States· Recruiting
- Research SiteVerified postcodeLos Angeles, United States· Recruiting
- Research SiteVerified postcodeLos Angeles, United States· Withdrawn
- Research SiteVerified postcodeNapa, United States· Recruiting
- Research SiteVerified postcodeNewport Beach, United States· Suspended
- Research SiteVerified postcodeSan Francisco, United States· Recruiting
- Research SiteVerified postcodeSanta Barbara, United States· Withdrawn
- Research SiteVerified postcodeSanta Rosa, United States· Recruiting
- Research SiteVerified postcodeAurora, United States· Recruiting
- Research SiteVerified postcodeNew Haven, United States· Recruiting
Common questions
What is 'hormone receptor-positive and HER2-negative' breast cancer?
This means your cancer's growth relies on hormones, but it doesn't have too much of a protein called HER2. This influences how it's treated.
What are CDK4/6 inhibitors and fulvestrant?
These are existing medicines used to treat hormone receptor-positive breast cancer. CDK4/6 inhibitors work by slowing down the growth of cancer cells, and fulvestrant blocks the effects of estrogen.
What is capivasertib?
Capivasertib is a new drug being tested in this study. It works by blocking certain signals within cancer cells that help them grow and divide.
Will I know if I'm getting the new drug or the standard treatment?
This is an 'open-label' study, which means both you and your study team will know which treatment combination you are receiving.
How long would I be in the study?
You would continue treatment as long as it's helping you and you're not having severe side effects. There would also be a follow-up period after stopping treatment.
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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