| CTRI Number |
CTRI/2026/03/105549 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Expressiom of Programmed death ligand-1(PD-L1)and Forkhead Box P3 (FOXP3) in HER 2 NEU positive breast carcinoma and its association with clinico pathological parameters |
|
Scientific Title of Study
|
Expression of Programmed death ligand-1(PD-L1)and Forkhead Bos P3 (FOXP3) in HER 2 NEU positive breast carcinoma and its association with clinico pathological parameters |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Keerthi V |
| Designation |
Junior Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pathology
Maulana Azad Medical College
Bahadur Shah Zafar Marg
Delhi
Central
DELHI
110002
India |
| Phone |
9266940111 |
| Fax |
|
| Email |
keerthivaddara099@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shramana Mandal |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pathology
Maulana Azad Medical College
Bahadur Shah Zafar Marg
Delhi
Central
DELHI
110002
India |
| Phone |
9811686401 |
| Fax |
|
| Email |
shra_mana@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Keerthi V |
| Designation |
Junior Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pathology
Maulana Azad Medical College
Bahadur Shah Zafar Marg
Delhi
Central
DELHI
110002
India |
| Phone |
9266940111 |
| Fax |
|
| Email |
keerthivaddara099@gmail.com |
|
|
Source of Monetary or Material Support
|
| Planning branch Maulana Azad Medical College |
|
|
Primary Sponsor
|
| Name |
Planning branch |
| Address |
Maulana Azad Medical College, Bhadur Shah ZAfar Marg, Delhi-110002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| KEERTHI VADDARA |
Maulana Azad Medical college |
Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi-110002
Central
DELHI |
9266940111
KEERTHIVADDARA099@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients with a diagnosis of breast carcinoma showing Her 2 neu positivity
2. Patients aged 18 years and above. |
|
| ExclusionCriteria |
| Details |
1. Patients who have received radiotherapy
2. Patients showing complete response to chemotherapy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To determine the proportion of cases showing PD-L1 positivity in Her 2 Neu positive cases of breast carcinoma.
2. To determine the proportion of cases showing FOXP3 positivity in Her 2 Neu positive cases of breast carcinoma. |
1. To determine the proportion of cases showing PD-L1 positivity in Her 2 Neu positive cases of breast carcinoma(baseline).
2. To determine the proportion of cases showing FOXP3 positivity in Her 2 Neu positive cases of breast carcinoma(baseline). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the proportion of cases showing FOXP3 & PD-L1 expression across various clinicopathological parameters such as tumour grade size & lymph node status in Her 2 neu positive cases of breast carcinoma |
Before & after chemotherapy
Time between chemotherapy & modified radical mastectomy |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title: Expression of PD-L1 and FOXP3 in HER2-positive Breast Carcinoma and its Association with Clinicopathological Parameters Summary: Breast carcinoma is the most common malignancy among women worldwide, with HER2-positive subtype representing an aggressive variant associated with poor prognosis and limited response in a subset of patients despite targeted therapies. The tumour immune microenvironment plays a crucial role in disease progression and treatment response, with Programmed Death-Ligand 1 (PD-L1) and Forkhead Box P3 (FOXP3) identified as key immunoregulatory markers. PD-L1 mediates immune evasion by inhibiting T-cell activation, while FOXP3 marks regulatory T cells that suppress antitumour immunity. Co-expression of these markers may signify an immunosuppressive phenotype contributing to therapeutic resistance.This cross-sectional study aims to evaluate the expression of PD-L1 and FOXP3 in HER2-positive post-chemotherapy breast carcinoma and correlate their expression with clinicopathological parameters including tumour grade, lymph node status, and size. Immunohistochemical analysis will be performed on resected specimens using monoclonal antibodies against PD-L1 and FOXP3, and results will be analyzed statistically.The findings are expected to enhance understanding of the immune landscape of HER2-positive breast carcinoma and may identify biomarkers predictive of therapeutic response and prognosis, particularly relevant for optimizing management in resource-limited settings such as India. |