Active not recruitingPHASE1INTERVENTIONAL

Study of AZD9833 Alone or in Combination in Women With Advanced Breast Cancer.

This study is for women with advanced breast cancer that is sensitive to hormones (ER+) but doesn't have too much of a protein called HER2 (HER2-). This type of cancer usually grows in response to hormones, so treatments often aim to block these hormones. The research is testing a new medicine called AZD9833. Scientists want to find out how safe AZD9833 is, what side effects it might cause, and if it helps treat this type of breast cancer. They are giving AZD9833 by itself or combining it with other medicines that are already used for breast cancer, like palbociclib, abemaciclib, or everolimus. This is an early-stage study, meaning it's one of the first times this new drug is being tested in people.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

AstraZeneca

Enrolment target

396

Start

11 Oct 2018

Estimated completion

24 Jun 2027

ER+ HER2- Advanced Breast Cancer

What is this study about?

This study is focused on a specific type of advanced breast cancer. This is cancer that has spread from its original site or has come back in the local area and can't be cured with standard treatments. The cancer involved in this study is called 'ER positive' (ER+) because it's sensitive to the hormone oestrogen, which can make it grow. It's also 'HER2 negative' (HER2-), meaning it doesn't have high levels of another protein that some breast cancers do.

The main goal of this research is to learn more about a new medicine called AZD9833. As this is a 'Phase 1' study, the researchers are primarily checking if the new drug is safe for people and what dose works best without causing too many problems. They are also looking to see if it causes any side effects and how the body handles the medicine. The study will try AZD9833 on its own and also in combination with several other well-known breast cancer drugs like palbociclib, everolimus, and ribociclib. The idea behind combining treatments is often to make them more effective.

By taking part, you would be helping doctors understand if AZD9833 could be a new, helpful treatment option for this type of breast cancer in the future. The study is designed to carefully monitor participants to ensure their safety while gathering important information about this potential new medicine.

Key takeaways

This study tests a new drug, AZD9833, for advanced ER+ HER2- breast cancer.
It aims to find safe doses and understand side effects, alone or in combination with other drugs.
Participation involves regular hospital visits for checks and scans.
This is an early-stage study, so the full benefits and risks of AZD9833 are not yet known.
You can stop participating in the study at any time.

Who may be eligible?

This study is for women aged 18 or over. Your breast cancer must be advanced, meaning it has spread or come back in the local area and can't be cured. The cancer must also be 'ER positive' (oestrogen receptor positive) and 'HER2 negative'.

You would have already tried at least one hormone-based treatment for your advanced or spread cancer, and it would no longer be working or causing too many problems. You might have had some chemotherapy for your advanced cancer, but no more than two different types. If you are still having periods (pre-menopausal), you would need to be having ongoing treatment to suppress your hormones, usually with an LHRH agonist.

Doctors will also check your general health, how well you can move around, and that there's at least one area of your cancer they can measure to see if the treatment is working.

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 female and aged 18 or over?
Do you have advanced breast cancer that is ER positive and HER2 negative?
Has your cancer progressed after at least one hormone therapy?
Are you able to attend regular hospital appointments for tests and scans?
If pre-menopausal, are you willing to continue hormone-suppressing therapy?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the study medicine, AZD9833, either alone or with another approved cancer drug. The exact treatment you receive would depend on which part of the study you are in. You would have regular visits to the hospital for checks, which will include blood tests, physical examinations, and scans (like CT or MRI) to see how you are doing and if the cancer is responding to the treatment. These visits are important for monitoring your safety and how the treatment is affecting you.

The study will start by slowly increasing the dose of AZD9833 to find the safest and most effective amount. The total duration of your participation would involve taking the study medication for as long as it is helping you or until unacceptable side effects occur. After you stop taking the study medication, you would have follow-up visits or calls to monitor your health.

Potential risks and benefits

Participating in a clinical trial may offer some potential benefits. You would receive a new, experimental treatment that might help your specific cancer, and you would be closely monitored by a dedicated medical team. However, there are also potential risks. New drugs can have side effects that are not yet fully known, and some side effects could be serious. The treatment may also not work for you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (17)

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

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Aurora, United States
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Sarasota, United States
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Philadelphia, United States
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Nashville, United States
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Salt Lake City, United States
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Barcelona, Spain
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Barcelona, Spain
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Madrid, Spain
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Madrid, Spain
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Seville, Spain
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Valencia, Spain
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Cambridge, United Kingdom

Common questions

What does 'ER positive, HER2 negative' mean?

It means your breast cancer is sensitive to the hormone oestrogen (ER positive) and often grows because of it. It does not have high levels of a protein called HER2 (HER2 negative).

What is a 'Phase 1' study?

A Phase 1 study is an early stage of research. Its main aim is to find out if a new drug is safe for people to take, what dose is best, and what side effects it might have.

Can men join this study?

No, this specific study is only for women.

Will I definitely get the new drug AZD9833?

Yes, all participants in this study will receive AZD9833, either on its own or combined with other existing cancer medicines.

What if I've already had other breast cancer treatments?

That's okay; the study allows for people who have had previous treatments, including hormone therapy and certain types of chemotherapy, as long as your cancer has progressed.