Breast CancerNCT07056205
Comparative Expression of ER,PR and HER2/Neu in Initial and Recurrent Breast Cancer.
An observational study of Breast Cancer, run by Sohag University at 1 site in Egypt.
Trial summary
Expression of ER, PR and HER2/neu in initial and recurrent breast cancer and correlate the results to different clinical and pathological parameters as patient age,sex, tumor location, status of nodal involvement and lymphovascular invasion Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: archived histological slides and immune-stained slides of100 patient with initial and recurrent mammary carcinoma will be obtained from Pathology Laboratory at Sohag Oncology Center.
Who may be able to join
- Patients with excised breast cancer then experienced recurrence at same site. Patients with evaluated ER, PR and HER2/neu for both initial and recurrent tumors.
Who cannot join
- Cases with insufficient clinical of pathological data. Deficient ER, PR and HER2/neu status in either initial or recurrent tumor
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Expression of ER, PR and HER2/neu in initial and recurrent breast cancer and correlate the results to different clinical and pathological parameters as patient age,sex, tumor location, status of nodal involvement and lymphovascular invasion
Read the detailed description
Clinical data, pathological data, expression status of ER, PR and HER2/neu of both initial tumor and recurrent tumor and received treatment for BC patients diagnosed between January 2021 and December 2024 will be extracted from archive of multidisciplinary team (MDT) for management of BC at Sohag Oncology Center. In addition; hematoxylin and eosin stained slides and immune-stained slides for ER, PR and HER2/neu for selected patient's will be retrieved from archives of Pathology unit at Sohag Oncology Center and reviewed to confirm pathological features, ER expression, PR expression and HER2 status of both initial and recurrent tumor tissues.
- Conditions
- Breast Cancer
- Keywords
- ER,PR,HER2/neu,breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| archived histological slides and immune-stained slides of 100 patient with breast cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between initial and recurrent breast cancer in immunohistochemical expression of ER,PR and HER2/neu
Measured: 6 months
Secondary outcomes (1)
Correlate the results of immunohistochemical expression of ER,PRand HER2/neu with the patients age ,sex,nodal status and lymphovascular invasion
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 posted9 Jul 2025
- Study start1 Jan 2021
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelmoaty Nafady Abdelmoaty, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056205
- Sponsor's protocol ID
- Soh-Med--25-5-1MS
- Status last verified
- May 2025
- First submitted
- 29 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No decided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Expression of ER,PR and HER2/Neu in Initial and Recurrent Breast Cancer.
- ClinicalTrials.gov ID
- NCT07056205
- Acronym / sponsor ID
- Soh-Med--25-5-1MS
- Conditions
- Breast Cancer
- Keywords
- ER,PR,HER2/neu,breast cancer
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Jul 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.
Expression of ER, PR and HER2/neu in initial and recurrent breast cancer and correlate the results to different clinical and pathological parameters as patient age,sex, tumor location, status of nodal involvement and lymphovascular invasion
Detailed description
Clinical data, pathological data, expression status of ER, PR and HER2/neu of both initial tumor and recurrent tumor and received treatment for BC patients diagnosed between January 2021 and December 2024 will be extracted from archive of multidisciplinary team (MDT) for management of BC at Sohag Oncology Center. In addition; hematoxylin and eosin stained slides and immune-stained slides for ER, PR and HER2/neu for selected patient's will be retrieved from archives of Pathology unit at Sohag Oncology Center and reviewed to confirm pathological features, ER expression, PR expression and HER2 status of both initial and recurrent tumor tissues.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| archived histological slides and immune-stained slides of 100 patient with breast cancer | – | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- archived histological slides and immune-stained slides of100 patient with initial and recurrent mammary carcinoma will be obtained from Pathology Laboratory at Sohag Oncology Center.
Key inclusion criteria (1 listed)
- Patients with excised breast cancer then experienced recurrence at same site. Patients with evaluated ER, PR and HER2/neu for both initial and recurrent tumors.
Key exclusion criteria (1 listed)
- Cases with insufficient clinical of pathological data. Deficient ER, PR and HER2/neu status in either initial or recurrent tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison between initial and recurrent breast cancer in immunohistochemical expression of ER,PR and HER2/neu
Time frame: 6 months
1 secondary outcome
Correlate the results of immunohistochemical expression of ER,PRand HER2/neu with the patients age ,sex,nodal status and lymphovascular invasion
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: Undecided. No decided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, 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: enrolling by invitation, as of the sponsor's last update on 9 Jul 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Comparison between initial and recurrent breast cancer in immunohistochemical expression of ER,PR and HER2/neu (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 9 Jul 2025.