| CTRI Number |
CTRI/2026/01/101797 [Registered on: 22/01/2026] Trial Registered Prospectively |
| Last Modified On: |
21/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Real-Life Use of Pembrolizumab for patients With Breast Cancer. |
|
Scientific Title of Study
|
Real World Data on Pembrolizumab in Triple-Negative Breast Cancer Patients – A
Retrospective Observational Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anbarasan Sekar |
| Designation |
Assistant Professor |
| Affiliation |
Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre |
| Address |
Department of Medical Oncology Room No.210 Pay Master Shodhika, Advanced Centre for Treatment, Research and Education in Cancer Tata Memorial Centre, Plot No 1 and 2 Sector 22. Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
08124227205 |
| Fax |
|
| Email |
anbarasan157@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anbarasan Sekar |
| Designation |
Assistant Professor |
| Affiliation |
Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre |
| Address |
Department of Medical Oncology Room No.210 Pay Master Shodhika, Advanced Centre for Treatment, Research and Education in Cancer Tata Memorial Centre, Plot No 1 and 2 Sector 22. Kharghar Navi Mumbai
MAHARASHTRA
410210
India |
| Phone |
08124227205 |
| Fax |
|
| Email |
anbarasan157@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anbarasan Sekar |
| Designation |
Assistant Professor |
| Affiliation |
Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre |
| Address |
Department of Medical Oncology Room No.210 Pay Master Shodhika, Advanced Centre for Treatment, Research and Education in Cancer Tata Memorial Centre, Plot No 1 and 2 Sector 22. Kharghar Navi Mumbai
MAHARASHTRA
410210
India |
| Phone |
08124227205 |
| Fax |
|
| Email |
anbarasan157@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Medical Oncology Room No.210 Pay Master Shodhika, Advanced Centre for Treatment, Research and Education in Cancer Tata Memorial Centre, Plot No 1 and 2 Sector 22. Kharghar Navi Mumbai
MAHARASHTRA
410210
India |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)Tata Memorial Centre Plot No. 1 and 2 Sector 22 Kharghar, Navi Mumbai - 410210. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Anbarasan Sekar |
Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre |
Department of Medical Oncology Room No.210, Pay master Shodhika, , Sector 22, Kharghar , Navi Mumbai - 410210
Raigarh
MAHARASHTRA
Raigarh
MAHARASHTRA |
8124227205
anbarasan157@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) III |
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 |
80.00 Year(s) |
| Gender |
Female |
| Details |
-Histologically confirmed diagnosis of triple negative breast cancer.
-Estrogen receptor expression less than 1 percent.
-Progesterone receptor expression less than 1 percent.
-Human epidermal growth factor receptor 2 negative status defined as immunohistochemistry score 0 or 1 plus, or immunohistochemistry score 2 plus with negative fluorescence in situ hybridization.
-Received at least one dose of pembrolizumab as part of the treatment regimen in either the neoadjuvant or adjuvant setting for early stage triple negative breast cancer, or in the first line or subsequent lines of therapy for metastatic triple negative breast cancer.
-Programmed death ligand 1 expression tested and documented where available, for example combined positive score using Dako 22C3 or an equivalent assay.
-Availability of baseline clinical data including staging and treatment plan, and a minimum of one post treatment response assessment or follow up evaluation.
-Treated at TMH or ACTREC between January 1 2023 and September 30 2025. |
|
| ExclusionCriteria |
| Details |
-Participation in blinded or placebo controlled interventional clinical trials during pembrolizumab therapy.
-Patients with incomplete or missing essential clinical or treatment records, including survival or response outcomes.
-Presence of active autoimmune disease requiring systemic immunosuppressive therapy within the past 2 years, excluding physiologic replacement such as thyroiditis.
-Concurrent active malignancies, except for adequately treated non melanoma skin cancer or in situ cervical carcinoma.
-Known untreated or symptomatic central nervous system metastases at the time of pembrolizumab initiation.
-Prior treatment with other immune checkpoint inhibitors such as nivolumab or atezolizumab, unless pembrolizumab is being administered in a subsequent line due to intolerance or disease progression. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Progression-Free Survival: The time from the initiation of pembrolizumab-based therapy to the first occurrence of disease progression or death from any cause, whichever occurs first.
2 Overall Survival: Time from the initiation of therapy to death from any cause.
3 Pathological Complete Response: For early-stage TNBC patients receiving neoadjuvant pembrolizumab: pCR is defined as no residual invasive cancer in the breast and lymph nodes ypT0 or Tis ypN0 at the time of surgery.
|
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Disease Free Survival
Time from date of diagnosis to first recurrence local or distant or death from any cause
Objective Response Rate
Proportion of patients achieving complete or partial response as per RECIST version 1 point 1 in metastatic disease
Safety and Tolerability
Incidence and severity of adverse events including immune related adverse events graded by CTCAE version 5 point 0
Treatment Discontinuation Rate
Proportion of patients discontinuing pembrolizumab due to toxicity financial constraints or disease progression
Biomarker Association
Correlation of PD L1 expression with clinical outcomes including progression free survival overall survival and objective response rate |
1 year |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/02/2026 |
| 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
|
Triple-negative breast cancer (TNBC) is one of the most aggressive and hard-to-treat types of breast cancer. It doesn’t respond to common treatments like hormone therapy or HER2-targeted drugs. Pembrolizumab is a medicine that helps the body’s immune system fight cancer. It has been approved for use in several cancers, including TNBC, based on results from international studies. However, these studies usually take place in highly controlled environments and may not show how the treatment works in real-life hospitals, especially in countries like India, where access to advanced treatments can be limited. This study will look back at the medical records of patients with early-stage or advanced TNBC who were treated with pembrolizumab at Tata Memorial Hospital (TMH) and ACTREC between January 1, 2023, and September 30, 2025. The goal is to understand how long patients lived after treatment and how long they stayed without the disease getting worse. The study will also look at how well the treatment worked and whether patients experienced any side effects. It will also check how well the usual treatment worked in these patients. The findings will help doctors understand how well pembrolizumab works for TNBC patients in India and how to use it better. It may also point out areas where patient care can be improved. |