Oncology Treatment Related Ocular Surface Changes

NCT07666724 | Completed

• 1 other identifier: OGYEI/18718-6/2021
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Neoplasm, Exercise

Outcome Measures

Primary Outcomes (1)

• Tear film break up time

  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 .

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Ocular Surface Disease Index

  through study completion, an average of 1 year

Study Arms (1)

Trastuzumab treatment

Drug: Trastuzumab (Herceptin)

Interventions

Trastuzumab (Herceptin) DRUG

trastuzumab treatment as the oncoteam advised

Trastuzumab treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

location Semmelweis University Budapest

You may qualify if:

• 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).

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University Ophthalmology Department

Budapest, 1085, Hungary

Location

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD senior lecturer

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 24, 2026
• Study Start: May 18, 2021
• Primary Completion: May 31, 2026
• Study Completion: May 31, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)