| CTRI Number |
CTRI/2024/02/062710 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of Immunotherapy in Triple negative breast cancer after surgery |
|
Scientific Title of Study
|
Addition of low-dose pembrolizumab to capecitabine for residual triple negative breast cancer post neoadjuvant chemotherapy: An investigator-initiated multicentric open-labelled phase III randomized controlled clinical trial |
| Trial Acronym |
SCRIPT Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Atul Batra |
| Designation |
Associate Professor |
| Affiliation |
Dr. B. R. Ambedkar, Institute Rotary Cancer Hospital |
| Address |
Room No 160D, First Floor, DR.B.R.A.IRCH, AIIMS, New Delhi
AIIMS
New Delhi
DELHI
110029
India |
| Phone |
9013078407 |
| Fax |
|
| Email |
batraatul85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul Batra |
| Designation |
Associate Professor |
| Affiliation |
Dr. B. R. Ambedkar, Institute Rotary Cancer Hospital |
| Address |
Room No 160D, First Floor, DR.B.R.A.IRCH, AIIMS, New Delhi
AIIMS
DELHI
110029
India |
| Phone |
9013078407 |
| Fax |
|
| Email |
batraatul85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Atul Batra |
| Designation |
Associate Professor |
| Affiliation |
Dr. B. R. Ambedkar, Institute Rotary Cancer Hospital |
| Address |
Room No 160D, First Floor, DR.B.R.A.IRCH, AIIMS, New Delhi
AIIMS
DELHI
110029
India |
| Phone |
9013078407 |
| Fax |
|
| Email |
batraatul85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, New Delhi |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Indian Council of Medical Research. V. Ramalingaswami Bhawan, P.O. Box No. 4911. Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Atul Batra |
AIIMS, New Delhi |
Room No-160D, First Floor,
DR. B.R.A.IRCH, AIIMS, East Ansari Nagar, New Delhi
New Delhi
DELHI |
9013078407
batraatul85@gmail.com |
| Dr Sourav Kumar Mishra |
All India Institute of Medical Sciences, Bhubaneswar |
All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Odisha-751019
Khordha
ORISSA |
7008651823
drskmishra1984@gmail.com |
| Dr Parmod Kumar |
All India Institute of Medical Sciences, Jodhpur |
Room No- 515, 5th Floor Department of Medical Oncology/ Hematology, Basni First Phase, Heavy Industrial Area Phase-2 Jodhpur-342005, Rajasthan
Jodhpur
RAJASTHAN |
9810200367
parmodkpal@gmail.com |
| Dr Amit Sehrawat |
All India Institute of Medical Sciences, Rishikesh |
Room Number 016512, Department of Medical Oncology Hematology, Level 6, A Block Medical College Building, Virbhadra Road, Rishikesh 249203, Uttaranchal
Dehradun
UTTARANCHAL |
9958474477
dramitsehrawat@gmail.com |
| Dr Biswajit Dubashi |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Department of Medical Oncology, Regional Research Center, Campus Rd, Gorimedu, Dhanvantari Nagar, Pondicherry, 605006
Pondicherry
PONDICHERRY |
8056338405
dr.biswajitdm@gmail.com |
| Dr Gaurav Prakash |
Post Graduate Institute of Medical Education & Research |
Room No-18, Ground Floor, Nehru hospital extension, PGIMER, Sector-12, Chandigarh-160012
Chandigarh
CHANDIGARH |
9914209678
drgp04@gmail.com |
| Dr Kaushal Kalra |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
Old SIC building, Medical oncology block, VMMC and Safdarjung Hospital, New Delhi- 110029
West
DELHI |
9968663394
kaushalkalra@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| AIIMS Institute Ethics Committee |
Approved |
| AIIMS, Jodhpur Institutional Ethics Committee |
Approved |
| AIIMS, Rishikesh Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Bhubaneswar |
Approved |
| Institutional Ethics Committee, Postgraduate Institute of Medical Education and Research, Chandigarh |
Approved |
| Institutional Ethics Committee, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
Approved |
| JIPMER Institutional Ethics Committee Interventional Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Capecitabine |
Capecitabine 1250mg/m2 twice daily for 14 days every 21 days for 8 cycles. |
| Intervention |
Pembrolizumab with Capecitabine |
4 cycles of pembrolizumab 50mg flat dose infusion every 6 weeks with capecitabine 1250mg/m2 twice daily for 14 days every 21 days for 8 cycles. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who sign informed consent.
2. Patients who have residual disease after NACT and Surgery. |
|
| ExclusionCriteria |
| Details |
1. Patients who have pathological complete response.
2. Patients who have contraindication of any Auto Immune Disorder.
3. Patients who have only DCIS present in their residual disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To compare invasive disease-free survival of patients with residual TNBC after NACT in two arms: a. Pembrolizumab and capecitabine b. Capecitabine |
18 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare overall survival in the two-arms
2. To assess the Quality of life and safety of the patients in the two-arms
3. To assess the correlation of PDL1 expression by IHC, genomic profile and tumour mutational burden with response to low-dose pembrolizumab.
|
4 years |
|
|
Target Sample Size
|
Total Sample Size="428"
Sample Size from India="428"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 the most
aggressive subtype of breast cancer, and is associated with worse long-term
survival outcomes when compared with other subtypes, even for early stage
disease (1). The preferred approach for treating patients with TNBC has evolved
to include neoadjuvant chemotherapy (NACT) followed by surgery(2). This
approach provides an opportunity to assess the pathological response to
chemotherapy in the resected specimen. Pathological complete response (PCR),
although not a sine qua non of cure in TNBC, is unequivocally associated with
significantly better long-term survival when compared to those who have
residual disease after neoadjuvant chemotherapy (NACT)(3). Despite several
advances, around 50-60% of patients with TNBC treated with NACT followed by
surgery will have residual disease after NACT(4). Capecitabine is the current
standard of care for these patients(5).
Rationale
The study addresses a large unmet need for
incorporating immunotherapy in treating patients with TNBC in resource-limited
settings.(12) Hypothesis/ Research question
We hypothesize that the addition of low-dose
pembrolizumab (50 mg flat dose q6 weekly for 4 cycles) to capecitabine in
patients with residual disease after neoadjuvant chemotherapy will improve
invasive disease-free survival as compared with capecitabine.
|