Oncology Treatment Related Ocular Surface Changes

clinical trial

The goal of this clinical trial is to learn if drug trastuzumab works to treat HER2 positive mamma carcinomas without causing dry eye related ocular surface changes in adults. The main questions it aims to answer are:

Does trastuzumab increase the dry eye related subjective symptoms? Does trastuzumab cause increased tear film instability and corneal epithelial staining (Oxford score), and lipid layer deterioration? Is a dose-dependent ocular surface effect identifiable attributable to trastuzumab and their modification by patient age?

Participants will:

Take drug trastuzumab-based chemotherapy based on the decision of the local onco-team.

Visit the clinic once every 3 months for checkups and tests Keep a diary of their ocular symptoms Make ocular examination and measure dry eye related parameters

Completed

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Key information

Conditions

Breast Neoplasm, Exercise Behavior Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Semmelweis University Ophthalmology Department

Budapest, 1085, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients received the following anti-HER2 therapies (according to protocol and national guidelines in Hungary at the time) administered either as monotherapy or in combination based on disease characteristics: trastuzumab (alone or in combination with pertuzumab), pertuzumab (in combination with trastuzumab), trastuzumab emtansine (monotherapy), and trastuzumab deruxtecan (monotherapy).
General eligibility criteria for anti-HER2 therapy included patients over the age of 18 years, of either sex, with invasive breast cancer showing HER2 overexpression as determined by immunohistochemistry (IHC) and/or fluorescence in situ hybridization (FISH).

Exclusion criteria

not willing to participate
any preexisting ocular disease
Eastern Cooperative Oncology Group (ECOG) performance status higher than 2 -inadequate bone marrow, renal, and hepatic function
untreated cardiac disease
left ventricular ejection fraction (LVEF) of less than 50%.

Treatment and study plan

Trastuzumab (Herceptin)

Drug

trastuzumab treatment as the oncoteam advised

Primary outcomes

Tear film break up time

Time frame: through study completion, an average of 1 year

Zero is equivalent to no stability, very short breaking up time. The more seconds, the longer the time and higher the stability, during the tear film remains healthy and stable .

Secondary outcomes

Ocular Surface Disease Index

Time frame: through study completion, an average of 1 year

Zero is equivalent to no pain or discomfort and the higher the points, the more pain and discomfort is detected. Range 0-100.

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Official study title

Ophthalmological Examination of Changes Induced by Therapy and Ocular Surface Abnormalities in Patients With Cancer

Acronym: 23AA01

Important dates

Study start: 2021
Primary completion: 2026
Study completion: 2026
First posted: Jun 24, 2026
Registry last updated: Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed