Active not recruitingPHASE3INTERVENTIONAL

A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease

This study is looking for a better first treatment for a specific type of advanced breast cancer. It compares two combinations of medicines: camizestrant plus palbociclib, and anastrozole plus palbociclib. This type of breast cancer has certain hormone receptors (ER-positive) but doesn't have too much of another protein called HER2 (HER2-negative). Participants will either have breast cancer that has spread to other parts of the body, or has come back after standard hormone treatment. Doctors want to see if camizestrant combined with palbociclib works better than anastrozole combined with palbociclib in slowing down the cancer's growth and helping people live longer without their cancer getting worse.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

1,370

Start

28 Jan 2021

Estimated completion

01 Feb 2029

ER-Positive HER2-Negative Breast Cancer

What is this study about?

This research study is focused on finding a new and potentially better way to treat advanced breast cancer. Specifically, it's for a type of breast cancer that has certain hormone receptors (known as ER-positive) but doesn't show high levels of another protein called HER2 (known as HER2-negative). This typically means the cancer's growth can be affected by hormones.

The study is comparing two different combinations of medicines: camizestrant with palbociclib, and anastrozole with palbociclib. Palbociclib and anastrozole are already used to treat breast cancer, but camizestrant is a newer drug that researchers hope might be more effective. The main aim is to see if camizestrant combined with palbociclib can work better as a first treatment for advanced breast cancer compared to the existing combination of anastrozole with palbociclib.

Participants in this study will have breast cancer that has either spread to other parts of the body (metastatic disease) or has returned after at least two years of standard hormone treatment. By comparing these two treatment groups, the researchers hope to learn which combination is more successful at slowing down the cancer's growth and helping patients live longer without their disease getting worse.

Key takeaways

Tests new drug camizestrant with palbociclib for advanced breast cancer.
Compares it to existing treatment anastrozole with palbociclib.
For ER-positive, HER2-negative breast cancer that has spread or returned.
Participants are randomly assigned to one of two treatment groups.
Aims to find a better first treatment to slow cancer growth.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to have a specific type of breast cancer. Your cancer must have certain hormone receptors (ER-positive) but not too much of another protein called HER2 (HER2-negative). It's for people whose breast cancer has either spread to other parts of the body (advanced disease) or has come back after at least two years of regular hormone treatment.

It's important that you haven't had any cancer treatment for your advanced breast cancer before. Also, if you've previously been treated with certain hormone therapies like anastrozole or similar drugs, you might not be able to join if your cancer returned quickly after that treatment.

The research team will also check your general health, including your organ function and how well you can do daily tasks, to make sure the study treatments would be suitable for 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.

Do I have ER-positive, HER2-negative breast cancer?
Has my breast cancer spread or come back after at least 2 years of hormone therapy?
Have I *not yet* received any cancer treatment for my advanced breast cancer?
Am I generally able to carry out my daily activities (ECOG score 0 or 1)?
Am I willing to have regular hospital visits, tests, and follow the treatment plan?
If I am pre-/peri-menopausal or a man, am I willing to take hormone-suppressing medication?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be assigned to one of two groups by chance, like flipping a coin. You won't know which group you're in, and neither will your doctors, to make sure the results are fair. One group will receive camizestrant, palbociclib, and a placebo (a dummy pill that looks like anastrozole). The other group will receive anastrozole, palbociclib, and a placebo (a dummy pill that looks like camizestrant). If you are a pre-/peri-menopausal woman or a man, you will also receive an LHRH agonist, which is a medicine to suppress hormones, throughout the study.

You will take your study medicines in cycles, with each cycle lasting 28 days. During these cycles, you'll have regular visits to the clinic for assessments, including blood tests, scans, and check-ups to monitor your health and how the treatment is working. These visits will help the doctors track your progress and any side effects. The total duration of your participation will depend on how you respond to the treatment.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as access to new medications like camizestrant before they are widely available, which could be more effective than standard treatments. However, there are also potential risks; the new drug combinations might have unknown side effects or might not work as well as hoped. All possible side effects will be carefully monitored by the research team. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (263)

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

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Mobile, United States
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Springdale, United States
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Harbor City, United States
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Solvang, 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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West Palm Beach, United States
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Indianapolis, United States
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Baton Rouge, United States
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Silver Spring, United States
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Boston, United States

Common questions

What does 'ER-positive HER2-negative breast cancer' mean?

This means your breast cancer has receptors that respond to hormones (estrogen), but it doesn't have too much of a protein called HER2. This type of cancer is often treated with hormone-blocking medicines.

What is a 'placebo'?

A placebo is a tablet or treatment that looks exactly like the real medicine but doesn’t contain any active drug. It helps researchers fairly compare treatments without knowing who is getting which one.

Why is the study 'double-blind'?

Being 'double-blind' means neither you nor your doctors will know which specific treatment you are receiving (camizestrant or anastrozole). This helps ensure that the results are as unbiased and accurate as possible.

What is an 'LHRH agonist'?

An LHRH agonist is a medicine that helps to block hormones, which can be important for treating hormone-sensitive breast cancer in some patients, including pre-menopausal women and men.

What if my cancer gets worse during the study?

Your health will be closely monitored throughout the study. If your cancer gets worse or if you experience severe side effects, your study doctors will discuss other treatment options with you and you can stop participating at any time.