NCT Number: NCT06767462
An Ophthalmic Safety Study in Patients With Breast Cancer
To assess ophthalmic health in parallel cohorts of patients with breast cancer
This study is active but is not currently recruiting participants.
Notify MeKey information
Age range
18 year–130 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Research Site, CABA, Argentina
About this study
This is a multicentre study assessing the ophthalmic safety in patients who are participating in a qualifying study. The study will include two cohorts of at least 60 individuals each.
To be able to account for events associated with aging, worsening of pre-existing conditions, etc., ophthalmic study assessments will be performed in parallel in two cohorts at the same timepoints. The duration of the study assessment period will be approximately 12 months. Longer duration of the study would result in additional patient burden.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
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Visual Acuity Testing (Snellen units)
Time frame: Ophthalmic review by central reader until 28 days after End of Study visit.
To detect potential impairment in central vision in patients with breast cancer.
-
Slit Lamp examination (normal/abnormal)
Time frame: Ophthalmic review by local ophthalmologist until 28 days after End of Study visit.
To detect any corneal changes or lens changes (eg, cataracts) that could impact high and low contrast acuity/visual field in patients with breast cancer.
-
Optical Coherence Tonometry (μm)
Time frame: Ophthalmic review by central reader until 28 days after End of Study visit.
To assess any structural change/damage to the eye or any long-term visual effects in patients with breast cancer.
-
Fundus Examination (normal/abnormal)
Time frame: Ophthalmic review by central reader until 28 days after End of Study visit.
To assess any structural change/damage to the eye or any long-term visual effects in patients with breast cancer.
Secondary outcomes
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Incidence and Severity of Adverse Events, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0)
Time frame: Until 28 days after the End of Study visit
To assess the ophthalmic safety in patients with breast cancer.
Sponsors and collaborators
Lead sponsor
AstraZeneca
Industry
Registry information
Official study title
A Multicentre Study Assessing Ophthalmic Safety in Patients With Breast Cancer
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jan 10, 2025
- Registry last updated
- Jun 16, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.