Triple Negative Breast CancerNCT05169853
Programmed Death-Ligand1 Expression in Her-2 Positive and Triple Negative Breast Cancer
An observational study of Triple Negative Breast Cancer and HER2-positive Breast Cancer, run by Ain Shams University at 1 site in Egypt.
Trial summary
Patients with Her-2 positive and triple negative breast cancer who received neoadjuvant chemotherapy will be included in the study. Paraffin blocks of preoperative core or tru-cut biopsies of the participants will be collected and tested for programmed death-ligand 1 (PD-L1) expression. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Triple Negative Breast Cancer, HER2-positive Breast Cancer
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 30 Oct 2024
- Phase
- Observational
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Breast Cancer patients attending Ain Shams University Clinical Oncology and Nuclear Medicine Department breast clinic from 2016 till 2021 with the following selection criteria
Who may be able to join
- Patients aged 18 years old or more
- Histologically proven invasive breast cancer
- Any T stage, any N Stage with no distant metastasis M0 as evident by clinical examination and sonomammography.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2.
- Patients with Her-2 positive Luminal B subtype, Her-2 enriched or triple negative breast cancer.
- Patients who completed their systemic neoadjuvant therapy.
Who cannot join
- Second malignancy
- Patients with early breast cancer clinicallyT1 (≤ 2 cm) N0
- Metastatic patients M1
- Patients with autoimmune diseases (Type I Diabetes mellitus, Systemic Lupus Erythematosus, Rheumatoid Arthritis, Sjogren's syndrome and Behcet disease)
- Patients on systemic steroids or other immunomodulators (as Methotrexate, Tacrolimus and Cyclosporine)
- Patients who started but didn't complete neoadjuvant systemic therapy
- Patients who didn't undergo surgery after neoadjuvant systemic therapy
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ain Shams University Clinical Oncology Department
Cairo, Abbasseya, 7154411
About this study
Official title: Correlation Between Programmed Death-Ligand1 Expression and Clinical Outcomes After Neoadjuvant Systemic Therapy in Her-2 Positive and Triple Negative Breast Cancer
Patients with Her-2 positive and triple negative breast cancer who received neoadjuvant chemotherapy will be included in the study. Paraffin blocks of preoperative core or tru-cut biopsies of the participants will be collected and tested for programmed death-ligand 1 (PD-L1) expression. The variation of PD-L1 expression among different breast cancer subtypes will be evaluated and the investigator will correlate between PD-L1 expression and pathological complete response to neoadjuvant systemic therapy.
Read the detailed description
Files of breast cancer patients attending breast cancer clinic at Ain Shams University Clinical oncology and nuclear medicine department will be viewed by the investigator and those who fit the selection criteria will be included in the study. Tru-cut or core tissue biopsies obtained from the participants for initial diagnosis will be collected and PD-L1 testing will be done on the specimens. Scoring of PD-L1 will be done using Combined positive score (CPS) score. PD-L1 expression will be evaluated among Her-2 positive and triple negative subtypes and will be correlated with pathological complete response after reviewing the postoperative pathology results of the patients.
- Keywords
- breast cancer, her-2 positive, triple negative, neoadjuvant therapy
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of PD-L1 expression in Her-2 positive and triple negative breast cancer
We will compare between percentage of PD-L1 positive cases in the studied Her-2 positive and triple negative breast cancer subtypes
Measured: through study completion, an average of 1 year
Correlation between pathological complete response and PD-L1 expression
We will correlate between PD-L1 expression and pathological complete response in the studied cases
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start1 Jan 2022
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Akram, Ain Shams University
- Investigators
- Iman A Sharawy, Professor, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169853
- Sponsor's protocol ID
- MD 177/2021
- Status last verified
- Aug 2024
- First submitted
- 24 Nov 2021
- Last updated
- 20 Aug 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Programmed Death-Ligand1 Expression and Clinical Outcomes After Neoadjuvant Systemic Therapy in Her-2 Positive and Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT05169853
- Acronym / sponsor ID
- MD 177/2021
- Keywords
- breast cancer, her-2 positive, triple negative, neoadjuvant therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 27 Dec 2021 (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.
Patients with Her-2 positive and triple negative breast cancer who received neoadjuvant chemotherapy will be included in the study. Paraffin blocks of preoperative core or tru-cut biopsies of the participants will be collected and tested for programmed death-ligand 1 (PD-L1) expression. The variation of PD-L1 expression among different breast cancer subtypes will be evaluated and the investigator will correlate between PD-L1 expression and pathological complete response to neoadjuvant systemic therapy.
Detailed description
Files of breast cancer patients attending breast cancer clinic at Ain Shams University Clinical oncology and nuclear medicine department will be viewed by the investigator and those who fit the selection criteria will be included in the study. Tru-cut or core tissue biopsies obtained from the participants for initial diagnosis will be collected and PD-L1 testing will be done on the specimens. Scoring of PD-L1 will be done using Combined positive score (CPS) score. PD-L1 expression will be evaluated among Her-2 positive and triple negative subtypes and will be correlated with pathological complete response after reviewing the postoperative pathology results of the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Breast Cancer patients attending Ain Shams University Clinical Oncology and Nuclear Medicine Department breast clinic from 2016 till 2021 with the following selection criteria
Key inclusion criteria (6 listed)
- Patients aged 18 years old or more
- Histologically proven invasive breast cancer
- Any T stage, any N Stage with no distant metastasis M0 as evident by clinical examination and sonomammography.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2.
- Patients with Her-2 positive Luminal B subtype, Her-2 enriched or triple negative breast cancer.
Key exclusion criteria (7 listed)
- Second malignancy
- Patients with early breast cancer clinicallyT1 (≤ 2 cm) N0
- Metastatic patients M1
- Patients with autoimmune diseases (Type I Diabetes mellitus, Systemic Lupus Erythematosus, Rheumatoid Arthritis, Sjogren's syndrome and Behcet disease)
- Patients on systemic steroids or other immunomodulators (as Methotrexate, Tacrolimus and Cyclosporine)
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
Variation of PD-L1 expression in Her-2 positive and triple negative breast cancer
Time frame: through study completion, an average of 1 year
We will compare between percentage of PD-L1 positive cases in the studied Her-2 positive and triple negative breast cancer subtypes
Correlation between pathological complete response and PD-L1 expression
Time frame: through study completion, an average of 1 year
We will correlate between PD-L1 expression and pathological complete response in the studied cases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
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Triple Negative Breast 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.
Iman A Sharawy, Professor study director
Ain Shams University
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 Triple Negative Breast Cancer and HER2-positive Breast Cancer, run by Ain Shams 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 20 Aug 2024. 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?
Results are not available in the source record.
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?
Variation of PD-L1 expression in Her-2 positive and triple negative breast cancer (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 20 Aug 2024.