Clinical trial NCT06767462: An Ophthalmic Safety Study in Patients With Breast Cancer
Official title: A Multicentre Study Assessing Ophthalmic Safety in Patients With Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ophthalmic Safety in Patients With Breast Cancer
Keywords: Ophthalmic Safety assessment
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2025-01-10
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are currently participating in qualifying studies

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Acuity Testing (Snellen units)
timeFrame: Ophthalmic review by central reader until 28 days after End of Study visit.
measure: Slit Lamp examination (normal/abnormal)
timeFrame: Ophthalmic review by local ophthalmologist until 28 days after End of Study visit.
measure: Optical Coherence Tonometry (μm)
timeFrame: Ophthalmic review by central reader until 28 days after End of Study visit.
measure: Fundus Examination (normal/abnormal)
timeFrame: Ophthalmic review by central reader until 28 days after End of Study visit.
Secondary outcomes:
measure: 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)
timeFrame: Until 28 days after the End of Study visit
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Research Site
state: California
city: Palo Alto
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Iowa City
country: United States
facility: Research Site
state: Iowa
city: New York
country: United States
facility: Research Site
state: New York
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Clairton
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Research Site
state: South Dakota
city: Bartlett
country: United States
facility: Research Site
state: Tennessee
city: Houston
country: United States
facility: Research Site
state: Texas
city: Buenos Aires
country: Argentina
facility: Research Site
city: Buenos Aires
country: Argentina
facility: Research Site
city: Caba
country: Argentina
facility: Research Site
city: Cordoba
country: Argentina
facility: Research Site
city: San Miguel de Tucuman
country: Argentina
facility: Research Site
city: San Miguel de Tucumán
country: Argentina
facility: Research Site
city: Edegem
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Alfenas
country: Brazil
facility: Research Site
city: Bela Vista
country: Brazil
facility: Research Site
city: Belo Horizonte
country: Brazil
facility: Research Site
city: Curitiba
country: Brazil
facility: Research Site
city: Lajeado
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Pouso Alegre
country: Brazil
facility: Research Site
city: Rio de Janeiro
country: Brazil
facility: Research Site
city: Sorocaba
country: Brazil
facility: Research Site
city: Tres Lagoas
country: Brazil
facility: Research Site
city: Vitoria
country: Brazil
facility: Research Site
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Santiago
country: Chile
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
city: Bordeaux Cédex
country: France
facility: Research Site
city: Caen
country: France
facility: Research Site
city: Nantes
country: France
facility: Research Site
city: Poitiers
country: France
facility: Research Site
city: Suresnes Cedex
country: France
facility: Research Site
city: Ashdod
country: Israel
facility: Research Site
city: Naharia
country: Israel
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Busan
country: Korea, Republic of
facility: Research Site
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Aguascalientes
country: Mexico
facility: Research Site
city: Cdmx
country: Mexico
facility: Research Site
city: San Pedro Garza Garcia
country: Mexico
facility: Research Site
city: Veracruz
country: Mexico
facility: Research Site
city: Nowa Sol
country: Poland
facility: Research Site
city: Amadora
country: Portugal
facility: Research Site
city: Braga
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Badalona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: L'Hospitalet de Llobregat
country: Spain
facility: Research Site
city: Leganes
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Majadahonda
country: Spain
facility: Research Site
city: Salamanca
country: Spain
facility: Research Site
Study officials:
References: