Programmed Death-Ligand1 Expression in Her-2 Positive and... | NCT05169853

Studies
Programmed Death-Ligand1 Expression in Her-2 Positive and Triple Negative Breast Cancer

NCT05169853

Sponsor

Ain Shams University

Status

Active, not recruiting

Last Update Posted

Aug 20, 2024Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Triple Negative Breast Cancer
HER2-positive Breast Cancer

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Oct 30, 2024Estimated

Completion Date

Oct 30, 2024Estimated

First Submitted Date

Nov 24, 2021

First Submission Date that Met QC Criteria

Dec 9, 2021

First Posted Date

Dec 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2024

Last Update Posted Date

Aug 20, 2024Actual

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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	through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Iman A Sharawy, Professor	Ain Shams University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams University Clinical Oncology Department		Cairo	Abbasseya	7154411	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D064726	Triple Negative Breast Neoplasms
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided