Ophthalmic Safety in Patients With Breast CancerNCT06767462
An Ophthalmic Safety Study in Patients With Breast Cancer
An observational study of Ophthalmic Safety in Patients With Breast Cancer, run by AstraZeneca at 50 sites in 11 countries.
Trial summary
To assess ophthalmic health in parallel cohorts of patients with breast cancer Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Ophthalmic Safety in Patients With Breast Cancer
- How many people
- 160 participants
- Where
- 50 sitesin 11 countries
- Study dates
- 5 Mar 2025to 9 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are currently participating in qualifying studies
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
50 sites in 11 countries.
50 sites in 11 countries
Spain17 sites
Research Site
Badalona, 08003
Research Site
Barcelona, 08028
Research Site
Barcelona, 08035
Research Site
Barcelona, 08036
Research Site
Girona, 17007
Research Site
L'Hospitalet de Llobregat, 08908
Research Site
Leganés, 28911
Research Site
Madrid, 28007
Research Site
Madrid, 28009
Research Site
Madrid, 28033
Research Site
Madrid, 28034
Research Site
Madrid, 28040
Research Site
Madrid, 28041
Research Site
Madrid, 28050
Research Site
Majadahonda, 28222
Research Site
Salamanca, 37007
Research Site
Sant Joan Despí, 08970
Brazil10 sites
Research Site
Alfenas, 37130-000
Research Site
Belo Horizonte, 30130-100
Research Site
Curitiba, 80810-050
Research Site
Lajeado, 95900000
Research Site
Porto Alegre, 90050-170
Research Site
Pouso Alegre, 37554-216
Research Site
São Paulo, 01321-001
Research Site
Sorocaba, 18060-105
Research Site
Três Lagoas, 79601-001
Research Site
Vitória, 29055-450
United States9 sites
Research Site
Bartlett, Tennessee, 38133
Research Site
Clairton, Pennsylvania, 15025
Research Site
Houston, Texas, 77030
Research Site
Iowa City, Iowa, 52242
Research Site
La Jolla, California, 92093
Research Site
Palo Alto, California, 94304
Research Site
Pittsburgh, Pennsylvania, 15219
Research Site
Sioux Falls, South Dakota, 57105
Research Site
Winston-Salem, North Carolina, 27104
Canada2 sites
Research Site
Montreal, Quebec, H2X 3E4
Research Site
Montreal, Quebec, H4A 3J1
About this study
Official title: A Multicentre Study Assessing Ophthalmic Safety in Patients With Breast Cancer
To assess ophthalmic health in parallel cohorts of patients with breast cancer
Read the detailed description
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.
- Keywords
- Ophthalmic Safety assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 from Qualifying Study | Not described | |
| Cohort 2 from Qualifying Study | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity Testing (Snellen units)
To detect potential impairment in central vision in patients with breast cancer.
Measured: Ophthalmic review by central reader until 28 days after End of Study visit.
Slit Lamp examination (normal/abnormal)
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.
Measured: Ophthalmic review by local ophthalmologist until 28 days after End of Study visit.
Optical Coherence Tonometry (μm)
To assess any structural change/damage to the eye or any long-term visual effects in patients with breast cancer.
Measured: Ophthalmic review by central reader until 28 days after End of Study visit.
Fundus Examination (normal/abnormal)
To assess any structural change/damage to the eye or any long-term visual effects in patients with breast cancer.
Measured: Ophthalmic review by central reader until 28 days after End of Study visit.
Secondary outcomes (1)
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)
To assess the ophthalmic safety in patients with breast cancer.
Measured: Until 28 days after the End of Study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start5 Mar 2025
- Primary completion9 Apr 2027 (estimated)
- Study completion9 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ophthalmic Safety in Patients With Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767462
- Sponsor's protocol ID
- D853AC00001
- Status last verified
- Jun 2026
- First submitted
- 15 Nov 2024
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Study Assessing Ophthalmic Safety in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT06767462
- Acronym / sponsor ID
- D853AC00001
- Keywords
- Ophthalmic Safety assessment
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 9 Apr 2027 (estimated)
- Study completion
- 9 Apr 2027 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess ophthalmic health in parallel cohorts of patients with breast cancer
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 from Qualifying Study | – | – |
| Cohort 2 from Qualifying Study | – | – |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are currently participating in qualifying studies
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
50 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ophthalmic Safety in Patients With Breast Cancer, run by AstraZeneca at 50 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Spain, Brazil, United States, Argentina, Belgium and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity Testing (Snellen units) (time frame: Ophthalmic review by central reader until 28 days after End of Study visit.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.