An Ophthalmic Safety Study in Patients With Breast Cancer

Last updated: March 24, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06767462
D853AC00001
  • Ages 18-130
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signed informed consent in the qualifying study.

  2. Signed informed consent in the ophthalmic study prior to any ophthalmic studyspecific assessments and procedures.

  3. Completed the baseline ophthalmic examination for this study before the first dosein the qualifying study.

  4. Meets all the eligibility criteria in the qualifying study

Exclusion

Exclusion Criteria:

  1. Patients not randomized and not receiving study assigned treatment in a qualifyingstudy.

  2. Patients with contraindications to any ophthalmic procedure required by the study orsensitivity/allergy to pupil dilating agents.

  3. Judgement by the investigator that the patient should not participate in theophthalmic study if the patient is unlikely to comply with study procedures,restrictions, and requirements

Study Design

Total Participants: 160
Study Start date:
March 04, 2025
Estimated Completion Date:
July 06, 2027

Study 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.

Connect with a study center

  • Research Site

    Buenos Aires, C1425AYC
    Argentina

    Site Not Available

  • Research Site

    Caba, 1061
    Argentina

    Site Not Available

  • Research Site

    Cordoba, 5008
    Argentina

    Site Not Available

  • Research Site

    San Miguel de Tucuman, T4000IAK
    Argentina

    Site Not Available

  • Research Site

    San Miguel de Tucumán, 4000
    Argentina

    Site Not Available

  • Research Site

    Edegem, 2650
    Belgium

    Site Not Available

  • Research Site

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Research Site

    Liege, 4000
    Belgium

    Active - Recruiting

  • Research Site

    Alfenas, 37130-000
    Brazil

    Site Not Available

  • Research Site

    Bela Vista, 01321-001
    Brazil

    Site Not Available

  • Research Site

    Belo Horizonte, 30130-100
    Brazil

    Site Not Available

  • Research Site

    Curitiba, 80810-050
    Brazil

    Site Not Available

  • Research Site

    Lajeado, 95900000
    Brazil

    Site Not Available

  • Research Site

    Porto Alegre, 90050-170
    Brazil

    Site Not Available

  • Research Site

    Pouso Alegre, 37554-216
    Brazil

    Site Not Available

  • Research Site

    Rio de Janeiro, 20560-120
    Brazil

    Site Not Available

  • Research Site

    Sorocaba, 18060-105
    Brazil

    Site Not Available

  • Research Site

    Tres Lagoas, 79601-001
    Brazil

    Site Not Available

  • Research Site

    Vitoria, 29055-450
    Brazil

    Site Not Available

  • Research Site

    Montreal, Quebec H2X 3E4
    Canada

    Site Not Available

  • Research Site

    Santiago, 8331143
    Chile

    Site Not Available

  • Research Site

    Bordeaux Cédex, 33077
    France

    Site Not Available

  • Research Site

    Caen, 14000
    France

    Site Not Available

  • Research Site

    Nantes, 44202
    France

    Site Not Available

  • Research Site

    Poitiers, 86021
    France

    Site Not Available

  • Research Site

    Suresnes Cedex, 92151
    France

    Site Not Available

  • Research Site

    Ashdod, 7747629
    Israel

    Active - Recruiting

  • Research Site

    Naharia, 2210001
    Israel

    Site Not Available

  • Research Site

    Milano, 20132
    Italy

    Site Not Available

  • Research Site

    Busan, 48108
    Korea, Republic of

    Site Not Available

  • Research Site

    Daegu, 41931
    Korea, Republic of

    Site Not Available

  • Research Site

    Seoul, 6351
    Korea, Republic of

    Site Not Available

  • Research Site

    Aguascalientes, 20230
    Mexico

    Site Not Available

  • Research Site

    Cdmx, 03810
    Mexico

    Site Not Available

  • Research Site

    San Pedro Garza Garcia, 66220
    Mexico

    Site Not Available

  • Research Site

    Veracruz, 91851
    Mexico

    Site Not Available

  • Research Site

    Nowa Sol, 67-106
    Poland

    Site Not Available

  • Research Site

    Amadora, 2720-276
    Portugal

    Site Not Available

  • Research Site

    Braga, 4710-243
    Portugal

    Site Not Available

  • Research Site

    Lisboa, 1998-018
    Portugal

    Site Not Available

  • Research Site

    Badalona, 08003
    Spain

    Site Not Available

  • Research Site

    Barcelona, 08036
    Spain

    Site Not Available

  • Research Site

    L'Hospitalet de Llobregat, 08908
    Spain

    Site Not Available

  • Research Site

    Leganes, 28911
    Spain

    Site Not Available

  • Research Site

    Madrid, 28033
    Spain

    Site Not Available

  • Research Site

    Majadahonda, 28222
    Spain

    Site Not Available

  • Research Site

    Salamanca, 37007
    Spain

    Site Not Available

  • Research Site

    La Jolla, California 92093
    United States

    Site Not Available

  • Research Site

    Palo Alto, California 94304
    United States

    Site Not Available

  • Research Site

    San Diego, California 92123
    United States

    Site Not Available

  • Research Site

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Research Site

    New York, New York 10029
    United States

    Site Not Available

  • Research Site

    Winston-Salem, North Carolina 27104
    United States

    Site Not Available

  • Research Site

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Research Site

    Clairton, Pennsylvania 15025
    United States

    Suspended

  • Research Site

    Pittsburgh, Pennsylvania 15219
    United States

    Site Not Available

  • Research Site

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

  • Research Site

    Bartlett, Tennessee 38133
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77030
    United States

    Site Not Available

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