Braest CancerPhase 4breast cancerNCT06924229
Corneal Changes in Estrogen-Dependent Breast Cancer After Hormonal Treatment
A Phase 4 study testing Hormonal treatment in people with Braest Cancer and Dry Eye, run by Sohag University at 1 site in Egypt.
Trial summary
Aromatase inhibitors (AI) therapy is the treatment of choice for estrogen receptor-positive breast cancer (BC). While AIs effectively suppress tumor growth, estrogen deprivation may have negative impacts on the eyes. This work evaluated the anterior segment changes in estrogen-dependent BC after hormonal treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Braest Cancer, Dry Eye
- What is being tested?
- Hormonal treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females diagnosed with breast cancer
Who cannot join
- uncontrolled diabetes , auto immune diseases
Trial locations and contacts
1 site in 1 country.
About this study
Aromatase inhibitors (AI) therapy is the treatment of choice for estrogen receptor-positive breast cancer (BC). While AIs effectively suppress tumor growth, estrogen deprivation may have negative impacts on the eyes. This work evaluated the anterior segment changes in estrogen-dependent BC after hormonal treatment.
Read the detailed description
Aromatase inhibitors (AI) therapy is an important treatment for estrogen receptor-positive breast cancer (BC). This work evaluated the eye anterior segment changes in estrogen-dependent BC after hormonal treatment.
This cross-sectional study was conducted on female patients aged ≥18 who received treatment for BC. Patients were evaluated by a number of tests to determine the effects on the cornea and the lacrimal system
- Conditions
- Braest Cancer, Dry Eye
- Being tested
- Hormonal treatment
- Keywords
- corneal changes, breast cancer, hormonal treatment
- Medical subject headings
- Dry Eye Syndromes, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormonal treatmentDrug
hormonal treatment for breast cancer
| Study group | Role | What they receive |
|---|---|---|
| patients with breast cancer recieving hormonal treatment | Active comparator | evaluation of the effect of hormonal treatment on the cornea Receives: Drug: Hormonal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
tear break up time test and shirmer test
these tests done before starting treatment and in follow up after recieving treatment to evaluate the lacrimal function and dry eye
Measured: 6 months
Secondary outcomes (1)
Corneal thickness and endothelium hexagonality
Corneal thickness and hesagonality were evaluated before and after treatment with aromatase inhibitors
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start1 Jun 2024
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Braest CancerStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haitham Thabit, Sohag University
- Investigators
- Elshimaa abd almateen A mateen, Doctorate, Study chair, Sohag Universityalaa mahmoud m mahmoud, Study chair, mahmoudmohamed salah hamed s hamed, Doctorate, Study director, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924229
- Sponsor's protocol ID
- Soh-Med-24-03-14PD
- Acronym
- breast cancer
- Status last verified
- Jun 2024
- First submitted
- 17 Mar 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Changes in Estrogen-Dependent Breast Cancer After Hormonal Treatment
- ClinicalTrials.gov ID
- NCT06924229
- Acronym / sponsor ID
- breast cancer / Soh-Med-24-03-14PD
- Conditions
- Braest Cancer, Dry Eye
- Keywords
- corneal changes, breast cancer, hormonal treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aromatase inhibitors (AI) therapy is the treatment of choice for estrogen receptor-positive breast cancer (BC). While AIs effectively suppress tumor growth, estrogen deprivation may have negative impacts on the eyes. This work evaluated the anterior segment changes in estrogen-dependent BC after hormonal treatment.
Detailed description
Aromatase inhibitors (AI) therapy is an important treatment for estrogen receptor-positive breast cancer (BC). This work evaluated the eye anterior segment changes in estrogen-dependent BC after hormonal treatment.
This cross-sectional study was conducted on female patients aged ≥18 who received treatment for BC. Patients were evaluated by a number of tests to determine the effects on the cornea and the lacrimal system
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with breast cancer recieving hormonal treatment | Active comparator | Drug: Hormonal treatmentevaluation of the effect of hormonal treatment on the cornea |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Females diagnosed with breast cancer
Key exclusion criteria (1 listed)
- uncontrolled diabetes , auto immune diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hormonal treatmenthormonal treatment for breast cancer | Drug | patients with breast cancer recieving hormonal treatment |
Primary outcome
tear break up time test and shirmer test
Time frame: 6 months
these tests done before starting treatment and in follow up after recieving treatment to evaluate the lacrimal function and dry eye
1 secondary outcome
Corneal thickness and endothelium hexagonality
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- breast cancer therapyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Braest Cancer
RecruitingPhase 2
Dalpiciclib Plus Toremifene for First-line Advanced HR Positive and HER2 Negative Breast Cancer
CANCER, BRAEST CANCER
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elshimaa abd almateen A mateen, Doctorate study chair
Sohag University
alaa mahmoud m mahmoud study chair
mahmoud
mohamed salah hamed s hamed, Doctorate study director
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hormonal treatment in people with Braest Cancer and Dry Eye, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tear break up time test and shirmer test (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.