RecruitingOBSERVATIONAL

An Ophthalmic Safety Study in Patients With Breast Cancer

This study aims to carefully check the eye health of people who have breast cancer. It's designed to make sure any new or worsening eye changes are understood, whether they are a result of cancer treatment or simply part of getting older or existing health issues. Researchers will observe two separate groups of patients at the same time and regularly check their eyes over about 12 months. This helps them compare how eye health changes in different situations. The goal is to gather important safety information about how certain treatments might affect eyes in people with breast cancer, helping doctors provide the best care.

At a glance

Status

Recruiting

Sponsor

AstraZeneca

Enrolment target

160

Start

04 Mar 2025

Estimated completion

06 Jul 2027

Ophthalmic Safety in Patients With Breast Cancer

What is this study about?

This study is designed to carefully monitor the eye health of people living with breast cancer. When someone is undergoing treatment for breast cancer, doctors want to make sure that any new or worsening eye problems are properly understood. It's important to figure out if these changes are happening because of the specific cancer treatment, or if they are due to other common reasons like getting older, or if a pre-existing eye condition is simply progressing naturally.

To do this, the study will involve two groups of breast cancer patients who are already taking part in another main study (we call this a 'qualifying study'). Both groups will have their eyes checked regularly over approximately 12 months. By comparing the eye health of these two groups over the same period, researchers can get a clearer picture of what might be causing any eye changes.

The main reason for doing this study is to gather important safety information. By understanding how different treatments might affect the eyes, doctors can make better decisions about treatment plans and give patients clearer advice. This helps ensure that the care provided is as safe and effective as possible for people with breast cancer.

Key takeaways

This study focuses on eye safety for people with breast cancer.
It helps doctors understand if eye changes are treatment-related or due to other causes.
Participation lasts about 12 months with regular eye check-ups.
You must already be in another approved breast cancer study to join this one.
Your medical care for breast cancer will not be affected if you join or leave the study.
The information learned could help improve care for future breast cancer patients.

Who may be eligible?

To join this eye health study, you must already be taking part in another main breast cancer study that has been approved. You'll need to agree to join this eye study by signing a form, and you must have had your first eye check-up before you started any treatment in that main study.

There are a few reasons why you might not be able to join. If you weren't chosen for a specific treatment in your main breast cancer study, you won't be able to participate here. Also, if you have any health conditions that make certain eye tests unsafe for you, or if you're allergic to the drops used to widen your pupils, then this study wouldn't be suitable. Finally, if the study doctor thinks you might have difficulty following the study instructions and attending appointments, they may decide it's not the right fit 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.

Are you currently participating in another approved breast cancer study?
Have you signed the consent form for this eye study?
Did you have your first eye check before starting treatment in your main study?
Do you have any known allergies to eye drops used for examinations?
Are you able to attend all planned study appointments?

Answer every question to see your result.

What does participation involve?

If you join this study, your involvement will last for about 12 months. During this time, you will have regular eye check-ups alongside the treatment you are receiving in your main breast cancer study. These eye checks will be done at specific times to match the assessments in the other study you are in. The main focus is on carefully monitoring your eye health through various tests and examinations. The study is designed to avoid adding too much extra burden to your schedule, so the eye assessments are planned to fit in with your existing appointments as much as possible.

Potential risks and benefits

Taking part in this study may not directly benefit your breast cancer treatment. However, the information gathered could help doctors better understand how treatments affect eye health, which may benefit future patients. The potential risks involve the minor discomfort and very small chance of side effects from eye drops used during examinations, such as temporary blurry vision or sensitivity to light. You are free to withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (75)

Research Site
Verified postcode
La Jolla, United States· Not yet recruiting
Research Site
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Palo Alto, United States· Not yet recruiting
Research Site
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San Diego, United States· Withdrawn
Research Site
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Iowa City, United States· Recruiting
Research Site
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New York, United States· Not yet recruiting
Research Site
Verified postcode
Winston-Salem, United States· Not yet recruiting
Research Site
Verified postcode
Cleveland, United States· Not yet recruiting
Research Site
Verified postcode
Clairton, United States· Suspended
Research Site
Verified postcode
Pittsburgh, United States· Recruiting
Research Site
Verified postcode
Sioux Falls, United States· Not yet recruiting
Research Site
Verified postcode
Bartlett, United States· Not yet recruiting
Research Site
Verified postcode
Houston, United States· Not yet recruiting

Common questions

What is the main goal of this eye study?

The main goal is to carefully check the eye health of people with breast cancer to understand if any changes are due to their treatment or other reasons like getting older.

How long will I need to be in the study?

You will be in the study for about 12 months, during which you'll have regular eye check-ups.

Do I get any special treatment for my breast cancer by joining?

No, this study is only to check your eye health alongside your main breast cancer treatment. It doesn't change your breast cancer treatment itself.

Will I have to pay to be part of this study?

No, you will not have to pay to participate in the study or for any study-related eye assessments.

What if I decide I don't want to continue in the study?

You can leave the study at any time, and it will not affect the medical care you receive for your breast cancer.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.