An Ophthalmic Safety Study in Patients With Breast Cancer

NCT ID: NCT06767462

Last Updated: 2025-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-04

Study Completion Date

2027-07-06

Brief Summary

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

Detailed Description

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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.

Conditions

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Ophthalmic Safety in Patients With Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1 from Qualifying Study

No interventions assigned to this group

Cohort 2 from Qualifying Study

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Patients not randomized and not receiving study assigned treatment in a qualifying study.
2. Patients with contraindications to any ophthalmic procedure required by the study or sensitivity/allergy to pupil dilating agents.
3. 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

La Jolla, California, United States

Site Status NOT_YET_RECRUITING

Research Site

Palo Alto, California, United States

Site Status NOT_YET_RECRUITING

Research Site

San Diego, California, United States

Site Status WITHDRAWN

Research Site

Iowa City, Iowa, United States

Site Status RECRUITING

Research Site

New York, New York, United States

Site Status NOT_YET_RECRUITING

Research Site

Winston-Salem, North Carolina, United States

Site Status NOT_YET_RECRUITING

Research Site

Cleveland, Ohio, United States

Site Status NOT_YET_RECRUITING

Research Site

Clairton, Pennsylvania, United States

Site Status SUSPENDED

Research Site

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Research Site

Sioux Falls, South Dakota, United States

Site Status NOT_YET_RECRUITING

Research Site

Bartlett, Tennessee, United States

Site Status NOT_YET_RECRUITING

Research Site

Houston, Texas, United States

Site Status NOT_YET_RECRUITING

Research Site

Buenos Aires, , Argentina

Site Status NOT_YET_RECRUITING

Research Site

Buenos Aires, , Argentina

Site Status WITHDRAWN

Research Site

CABA, , Argentina

Site Status NOT_YET_RECRUITING

Research Site

Córdoba, , Argentina

Site Status NOT_YET_RECRUITING

Research Site

San Miguel de Tucumán, , Argentina

Site Status NOT_YET_RECRUITING

Research Site

San Miguel de Tucumán, , Argentina

Site Status NOT_YET_RECRUITING

Research Site

Edegem, , Belgium

Site Status NOT_YET_RECRUITING

Research Site

Leuven, , Belgium

Site Status RECRUITING

Research Site

Liège, , Belgium

Site Status RECRUITING

Research Site

Alfenas, , Brazil

Site Status NOT_YET_RECRUITING

Research Site

Belo Horizonte, , Brazil

Site Status NOT_YET_RECRUITING

Research Site

Curitiba, , Brazil

Site Status NOT_YET_RECRUITING

Research Site

Lajeado, , Brazil

Site Status NOT_YET_RECRUITING

Research Site

Porto Alegre, , Brazil

Site Status NOT_YET_RECRUITING

Research Site

Porto Alegre, , Brazil

Site Status NOT_YET_RECRUITING

Research Site

Pouso Alegre, , Brazil

Site Status NOT_YET_RECRUITING

Research Site

Rio de Janeiro, , Brazil

Site Status NOT_YET_RECRUITING

Research Site

São Paulo, , Brazil

Site Status NOT_YET_RECRUITING

Research Site

Sorocaba, , Brazil

Site Status NOT_YET_RECRUITING

Research Site

Três Lagoas, , Brazil

Site Status NOT_YET_RECRUITING

Research Site

Vitória, , Brazil

Site Status NOT_YET_RECRUITING

Research Site

Montreal, Quebec, Canada

Site Status NOT_YET_RECRUITING

Research Site

Montreal, Quebec, Canada

Site Status NOT_YET_RECRUITING

Research Site

Santiago, , Chile

Site Status NOT_YET_RECRUITING

Research Site

Santiago, , Chile

Site Status NOT_YET_RECRUITING

Research Site

Santiago, , Chile

Site Status WITHDRAWN

Research Site

Bordeaux Cédex, , France

Site Status NOT_YET_RECRUITING

Research Site

Caen, , France

Site Status NOT_YET_RECRUITING

Research Site

Nantes, , France

Site Status WITHDRAWN

Research Site

Poitiers, , France

Site Status NOT_YET_RECRUITING

Research Site

Suresnes, , France

Site Status NOT_YET_RECRUITING

Research Site

Ashdod, , Israel

Site Status RECRUITING

Research Site

Nahariya, , Israel

Site Status NOT_YET_RECRUITING

Research Site

Milan, , Italy

Site Status NOT_YET_RECRUITING

Research Site

Aguascalientes, , Mexico

Site Status WITHDRAWN

Research Site

Mexico City, , Mexico

Site Status WITHDRAWN

Research Site

San Pedro Garza García, , Mexico

Site Status WITHDRAWN

Research Site

Veracruz, , Mexico

Site Status WITHDRAWN

Research Site

Lodz, , Poland

Site Status NOT_YET_RECRUITING

Research Site

Nowa Sól, , Poland

Site Status NOT_YET_RECRUITING

Research Site

Amadora, , Portugal

Site Status NOT_YET_RECRUITING

Research Site

Braga, , Portugal

Site Status NOT_YET_RECRUITING

Research Site

Lisbon, , Portugal

Site Status WITHDRAWN

Research Site

Busan, , South Korea

Site Status WITHDRAWN

Research Site

Daegu, , South Korea

Site Status WITHDRAWN

Research Site

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

Research Site

Badalona, , Spain

Site Status RECRUITING

Research Site

Barcelona, , Spain

Site Status RECRUITING

Research Site

Barcelona, , Spain

Site Status RECRUITING

Research Site

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

Research Site

Girona, , Spain

Site Status NOT_YET_RECRUITING

Research Site

L'Hospitalet de Llobregat, , Spain

Site Status NOT_YET_RECRUITING

Research Site

Leganés, , Spain

Site Status NOT_YET_RECRUITING

Research Site

Madrid, , Spain

Site Status RECRUITING

Research Site

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Research Site

Madrid, , Spain

Site Status RECRUITING

Research Site

Madrid, , Spain

Site Status RECRUITING

Research Site

Madrid, , Spain

Site Status RECRUITING

Research Site

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Research Site

Madrid, , Spain

Site Status RECRUITING

Research Site

Majadahonda, , Spain

Site Status RECRUITING

Research Site

Salamanca, , Spain

Site Status NOT_YET_RECRUITING

Research Site

Sant Joan Despí, , Spain

Site Status NOT_YET_RECRUITING

Countries

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United States Argentina Belgium Brazil Canada Chile France Israel Italy Mexico Poland Portugal South Korea Spain

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

1-877-240-9479

Other Identifiers

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D853AC00001

Identifier Type: -

Identifier Source: org_study_id

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