Active — Not RecruitingNot Applicable

An Ophthalmic Safety Study in Patients With Breast Cancer

United States, Argentina, Belgium160 participantsStarted 2025-03-05

Plain-language summary

To assess ophthalmic health in parallel cohorts of patients with breast cancer

Who can participate

Age range

18 Years – 130 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Signed informed consent in the qualifying study.
. Signed informed consent in the ophthalmic study prior to any ophthalmic study specific assessments and procedures.
. Completed the baseline ophthalmic examination for this study before the first dose in the qualifying study.
. Meets all the eligibility criteria in the qualifying study

Exclusion criteria

. Patients not randomized and not receiving study assigned treatment in a qualifying study.
. Patients with contraindications to any ophthalmic procedure required by the study or sensitivity/allergy to pupil dilating agents.
. Judgement by the investigator that the patient should not participate in the ophthalmic study if the patient is unlikely to comply with study procedures, restrictions, and requirements

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual Acuity Testing (Snellen units)

Timeframe: Ophthalmic review by central reader until 28 days after End of Study visit.

Slit Lamp examination (normal/abnormal)

Timeframe: Ophthalmic review by local ophthalmologist until 28 days after End of Study visit.

Optical Coherence Tonometry (μm)

Timeframe: Ophthalmic review by central reader until 28 days after End of Study visit.

Fundus Examination (normal/abnormal)

Timeframe: Ophthalmic review by central reader until 28 days after End of Study visit.

Trial details

NCT IDNCT06767462

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-04-09

View on ClinicalTrials.gov More Ophthalmic Safety in Patients With Breast Cancer trials

Who can participate

Age range

18 Years – 130 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Signed informed consent in the qualifying study.
. Signed informed consent in the ophthalmic study prior to any ophthalmic study specific assessments and procedures.
. Completed the baseline ophthalmic examination for this study before the first dose in the qualifying study.
. Meets all the eligibility criteria in the qualifying study

Exclusion criteria

. Patients not randomized and not receiving study assigned treatment in a qualifying study.
. Patients with contraindications to any ophthalmic procedure required by the study or sensitivity/allergy to pupil dilating agents.
. Judgement by the investigator that the patient should not participate in the ophthalmic study if the patient is unlikely to comply with study procedures, restrictions, and requirements

What they're measuring

Visual Acuity Testing (Snellen units)

Timeframe: Ophthalmic review by central reader until 28 days after End of Study visit.

Slit Lamp examination (normal/abnormal)

Timeframe: Ophthalmic review by local ophthalmologist until 28 days after End of Study visit.

Optical Coherence Tonometry (μm)

Timeframe: Ophthalmic review by central reader until 28 days after End of Study visit.

Fundus Examination (normal/abnormal)

Timeframe: Ophthalmic review by central reader until 28 days after End of Study visit.