An Ophthalmic Safety Study in Patients With Breast Cancer

A Multicentre Study Assessing Ophthalmic Safety in Patients With Breast Cancer

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

Study Overview

• Status: Recruiting
• Conditions: Ophthalmic Safety in 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 Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1125ABD
    • Not yet recruiting
    • Research Site
  • Buenos Aires, Argentina, C1425AYC
    • Withdrawn
    • Research Site
  • Caba, Argentina, C1061
    • Not yet recruiting
    • Research Site
  • Cordoba, Argentina, 5008
    • Not yet recruiting
    • Research Site
  • San Miguel de Tucuman, Argentina, T4000IAK
    • Not yet recruiting
    • Research Site
  • San Miguel de Tucumán, Argentina, 4000
    • Not yet recruiting
    • Research Site
• Belgium
  • Edegem, Belgium, 2650
    • Not yet recruiting
    • Research Site
  • Leuven, Belgium, 3000
    • Recruiting
    • Research Site
  • Liege, Belgium, 4000
    • Recruiting
    • Research Site
• Brazil
  • Alfenas, Brazil, 37130-000
    • Not yet recruiting
    • Research Site
  • Belo Horizonte, Brazil, 30130-100
    • Not yet recruiting
    • Research Site
  • Curitiba, Brazil, 80810-050
    • Not yet recruiting
    • Research Site
  • Lajeado, Brazil, 95900000
    • Not yet recruiting
    • Research Site
  • Porto Alegre, Brazil, 90035-001
    • Not yet recruiting
    • Research Site
  • Porto Alegre, Brazil, 90050-170
    • Not yet recruiting
    • Research Site
  • Pouso Alegre, Brazil, 37554-216
    • Not yet recruiting
    • Research Site
  • Rio de Janeiro, Brazil, 20560-120
    • Not yet recruiting
    • Research Site
  • Sorocaba, Brazil, 18060-105
    • Not yet recruiting
    • Research Site
  • São Paulo, Brazil, 01321-001
    • Not yet recruiting
    • Research Site
  • Tres Lagoas, Brazil, 79601-001
    • Not yet recruiting
    • Research Site
  • Vitoria, Brazil, 29055-450
    • Not yet recruiting
    • Research Site
• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X 3E4
      • Not yet recruiting
      • Research Site
    • Montréal, Quebec, Canada, H4A 3J1
      • Not yet recruiting
      • Research Site
• Chile
  • Santiago, Chile, 7620157
    • Not yet recruiting
    • Research Site
  • Santiago, Chile, 7500587
    • Not yet recruiting
    • Research Site
  • Santiago, Chile, 8331143
    • Withdrawn
    • Research Site
• France
  • Bordeaux Cédex, France, 33077
    • Not yet recruiting
    • Research Site
  • Caen, France, 14000
    • Not yet recruiting
    • Research Site
  • Nantes, France, 44202
    • Withdrawn
    • Research Site
  • Poitiers, France, 86021
    • Not yet recruiting
    • Research Site
  • Suresnes Cedex, France, 92151
    • Not yet recruiting
    • Research Site
• Israel
  • Ashdod, Israel, 7747629
    • Recruiting
    • Research Site
  • Naharia, Israel, 2210001
    • Not yet recruiting
    • Research Site
• Italy
  • Milano, Italy, 20132
    • Not yet recruiting
    • Research Site
• Korea, Republic of
  • Busan, Korea, Republic of, 48108
    • Withdrawn
    • Research Site
  • Daegu, Korea, Republic of, 41931
    • Withdrawn
    • Research Site
  • Seoul, Korea, Republic of, 6351
    • Not yet recruiting
    • Research Site
• Mexico
  • Aguascalientes, Mexico, 20230
    • Withdrawn
    • Research Site
  • Cdmx, Mexico, 03810
    • Withdrawn
    • Research Site
  • San Pedro Garza Garcia, Mexico, 66220
    • Withdrawn
    • Research Site
  • Veracruz, Mexico, 91851
    • Withdrawn
    • Research Site
• Poland
  • Lodz, Poland, 90-302
    • Not yet recruiting
    • Research Site
  • Nowa Sol, Poland, 67-106
    • Not yet recruiting
    • Research Site
• Portugal
  • Amadora, Portugal, 2720-276
    • Not yet recruiting
    • Research Site
  • Braga, Portugal, 4710-243
    • Not yet recruiting
    • Research Site
  • Lisboa, Portugal, 1998-018
    • Withdrawn
    • Research Site
• Spain
  • Badalona, Spain, 08003
    • Recruiting
    • Research Site
  • Barcelona, Spain, 08036
    • Not yet recruiting
    • Research Site
  • Barcelona, Spain, 08035
    • Recruiting
    • Research Site
  • Barcelona, Spain, 08028
    • Recruiting
    • Research Site
  • Girona, Spain, 17007
    • Not yet recruiting
    • Research Site
  • L'Hospitalet de Llobregat, Spain, 08908
    • Not yet recruiting
    • Research Site
  • Leganes, Spain, 28911
    • Not yet recruiting
    • Research Site
  • Madrid, Spain, 28007
    • Recruiting
    • Research Site
  • Madrid, Spain, 28034
    • Recruiting
    • Research Site
  • Madrid, Spain, 28040
    • Recruiting
    • Research Site
  • Madrid, Spain, 28033
    • Recruiting
    • Research Site
  • Madrid, Spain, 28041
    • Not yet recruiting
    • Research Site
  • Madrid, Spain, 28050
    • Recruiting
    • Research Site
  • Madrid, Spain, 28009
    • Not yet recruiting
    • Research Site
  • Majadahonda, Spain, 28222
    • Recruiting
    • Research Site
  • Salamanca, Spain, 37007
    • Not yet recruiting
    • Research Site
  • Sant Joan Despi, Spain, 08970
    • Not yet recruiting
    • Research Site
• United States
  • California
    • La Jolla, California, United States, 92093
      • Not yet recruiting
      • Research Site
    • Palo Alto, California, United States, 94304
      • Not yet recruiting
      • Research Site
    • San Diego, California, United States, 92123
      • Withdrawn
      • Research Site
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • Research Site
  • New York
    • New York, New York, United States, 10029
      • Not yet recruiting
      • Research Site
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27104
      • Not yet recruiting
      • Research Site
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Not yet recruiting
      • Research Site
  • Pennsylvania
    • Clairton, Pennsylvania, United States, 15025
      • Suspended
      • Research Site
    • Pittsburgh, Pennsylvania, United States, 15219
      • Recruiting
      • Research Site
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Not yet recruiting
      • Research Site
  • Tennessee
    • Bartlett, Tennessee, United States, 38133
      • Not yet recruiting
      • Research Site
  • Texas
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who are currently participating in qualifying studies

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cohort 1 from Qualifying Study
Cohort 2 from Qualifying Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity Testing (Snellen units)	To detect potential impairment in central vision in patients with breast cancer.	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.	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.	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.	Ophthalmic review by central reader until 28 days after End of Study visit.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Until 28 days after the End of Study visit

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2025
• Primary Completion (Estimated): July 6, 2027
• Study Completion (Estimated): July 6, 2027

Study Registration Dates

• First Submitted: November 15, 2024
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): January 10, 2025

Study Record Updates

• Last Update Posted (Actual): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Ophthalmic Safety assessment
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: D853AC00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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
• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No