Active not recruitingPHASE3INTERVENTIONAL

Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)

This study, called SERENA-6, is for women with a type of advanced breast cancer that's hormone-positive and HER2-negative. It's specifically for those whose cancer has a gene mutation called ESR1. This mutation can sometimes make current treatments less effective. Participants in the study are already taking a combination of drugs: a CDK4/6 inhibitor (like palbociclib) and an aromatase inhibitor (like anastrozole). The main goal is to see if replacing the aromatase inhibitor with the new drug, AZD9833, works better at controlling the cancer in people with the ESR1 mutation. Researchers hope AZD9833, when combined with your current CDK4/6 inhibitor, will be more effective than continuing with your current aromatase inhibitor.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

315

Start

30 Jun 2021

Estimated completion

01 Sep 2028

ER-Positive HER2-Negative Breast Cancer

What is this study about?

Breast cancer is a common illness where some cells in the breast grow out of control and can form a lump or tumour. Sometimes, these cancer cells can spread to other parts of the body; this is called advanced breast cancer. Doctors and scientists are always looking for better ways to treat this condition.

This study focuses on a specific type of advanced breast cancer that's sensitive to hormones (called HR-positive) and doesn't have too much of a protein called HER2 (called HER2-negative). Many people with this type of cancer are treated with a combination of drugs, including a CDK4/6 inhibitor (like palbociclib or abemaciclib) and an aromatase inhibitor (like anastrozole or letrozole). These drugs work together to slow down the cancer's growth. However, sometimes the cancer can develop a change in a gene called ESR1. When this happens, the aromatase inhibitor part of the treatment might not work as well as it used to.

That's where the new drug, AZD9833, comes in. Researchers believe AZD9833 might work better than current aromatase inhibitors when combined with a CDK4/6 inhibitor, especially for people whose cancer has the ESR1 gene change. If you join this study, you would continue taking your current CDK4/6 inhibitor, but the aromatase inhibitor would be switched to either AZD9833 or a dummy drug (placebo) to see which combination is more effective at controlling the cancer. The aim is to find out if this new approach can keep your cancer from getting worse for longer.

Key takeaways

This study is for advanced HR+/HER2- breast cancer with an ESR1 gene change.
It tests if a new drug, AZD9833, is better than current treatments for this specific cancer.
Participants are randomly assigned to receive AZD9833 or standard treatment.
You would continue your existing CDK4/6 inhibitor, with the new drug replacing your current aromatase inhibitor.
Regular hospital visits and tests are part of the study participation.

Who may be eligible?

You might be able to join this study if you are at least 18 years old and have advanced breast cancer that cannot be removed by surgery or radiation. Your cancer must be HR-positive and HER2-negative, and it needs to have a specific gene change called an ESR1 mutation. Doctors will check for this mutation using a blood test.

To be eligible, you must also currently be taking a combination of an aromatase inhibitor (like anastrozole or letrozole) and a CDK4/6 inhibitor (like palbociclib, abemaciclib, or ribociclib) for at least six months. Your cancer must also not have worsened while you've been on this treatment. You should also be generally well enough to go about your daily activities.

There are also some reasons why you might not be able to join. For example, if you've had certain types of cancers in the past that might come back, or if you're taking other medicines or supplements that could interfere with the study drugs. Major health problems, infections, or recent surgeries might also prevent you from joining to ensure your safety.

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.

Do you have advanced breast cancer that cannot be treated by surgery or radiation?
Has your doctor confirmed your breast cancer is HR-positive and HER2-negative?
Have you been told your cancer has an ESR1 gene mutation?
Are you currently taking a CDK4/6 inhibitor (like palbociclib) and an aromatase inhibitor (like anastrozole) for at least 6 months?
Has your cancer not worsened while on your current CDK4/6 inhibitor and aromatase inhibitor treatment?
Are you aged 18 or over and generally able to perform your daily activities?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will continue with the CDK4/6 inhibitor you are currently using. However, the aromatase inhibitor you are taking will be replaced with either the new drug AZD9833 or a dummy pill (placebo). This is decided randomly, meaning you won't choose which one you receive, and for some time, neither you nor your doctor will know. All drugs will be provided by the study, and you will be asked to take them regularly as prescribed.

You will have regular appointments at the hospital for check-ups, blood tests, and scans to monitor your health and how your cancer is responding to the treatment. These visits will help the doctors understand if the new drug is working and to keep an eye on any side effects. The total duration of your participation will depend on how your cancer responds, but there will be ongoing follow-up for your safety and to track the effectiveness of the treatment. You can withdraw from the study at any time.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as access to a new drug (AZD9833) that is not yet widely available and could potentially work better for your specific type of cancer. The information gathered may also help others in the future by improving treatments for advanced breast cancer. However, there are also potential risks; you might experience side effects from the study drugs, some of which could be serious, or the treatment might not work for you. Close monitoring will be in place to manage any side effects. Remember, joining a clinical trial is always voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (265)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Research Site
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Phoenix, United States
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Hot Springs, United States
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Little Rock, United States
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Long Beach, United States
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San Diego, United States
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Santa Rosa, United States
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Grand Junction, United States
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Lone Tree, United States
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Fort Myers, United States
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Jacksonville, United States
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Jacksonville, United States
Research Site
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St. Petersburg, United States

Common questions

What is an ESR1 mutation?

An ESR1 mutation is a specific change in a gene that can sometimes develop in breast cancer cells. This change can make certain common breast cancer treatments less effective.

What kind of breast cancer is this study for?

This study is for advanced breast cancer that is hormone receptor-positive (HR-positive) and HER2-negative, and has spread to other parts of the body.

Will I definitely get the new drug AZD9833?

You will be randomly assigned to receive either AZD9833 or the current standard treatment (an aromatase inhibitor). There's also a chance you might receive a dummy pill (placebo) if that's part of the study design.

How long would I be in the study?

The length of your participation would depend on how your cancer responds to the treatment. You would continue as long as the treatment is helping and as long as you wish to stay in the study.

Will my usual doctor still be involved in my care?

Yes, your regular doctors will be informed if you join the study, and your overall care will continue to be managed by your medical team.