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CTRI Number  CTRI/2025/09/094348 [Registered on: 08/09/2025] Trial Registered Prospectively
Last Modified On: 04/09/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Real time genome analysis to personalise breast cancer treatment 
Scientific Title of Study   Personalised Breast Cancer Program- India (PBCP-I) 
Trial Acronym  PBCP-I 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjoy Chatterjee 
Designation  Senior Consultant Department of Radiation Oncology Tata Medical Center, Kolkata 
Affiliation  Tata Medical Centre, Kolkata  
Address  Department of Radiation Oncology, Tata Medical Centre, Newtown, Kolkata Kolkata WEST BENGAL 700160 India

Kolkata
WEST BENGAL
700160
India 
Phone  9038161825  
Fax    
Email  sanjoy.chatterjee@tmckolkata.com   
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjoy Chatterjee 
Designation  Senior Consultant Department of Radiation Oncology Tata Medical Center, Kolkata 
Affiliation  Tata Medical Centre, Kolkata  
Address  Department of Radiation Oncology, Tata Medical Centre, Newtown, Kolkata Kolkata WEST BENGAL 700160 India

Kolkata
WEST BENGAL
700160
India 
Phone  9038161825  
Fax    
Email  sanjoy.chatterjee@tmckolkata.com   
 
Details of Contact Person
Public Query
 
Name  Dr Sanjoy Chatterjee 
Designation  Senior Consultant Department of Radiation Oncology Tata Medical Center, Kolkata 
Affiliation  Tata Medical Centre, Kolkata  
Address  Department of Radiation Oncology, Tata Medical Centre, Newtown, Kolkata Kolkata WEST BENGAL 700160 India

Kolkata
WEST BENGAL
700160
India 
Phone  9038161825  
Fax    
Email  sanjoy.chatterjee@tmckolkata.com   
 
Source of Monetary or Material Support  
Blockchain for Impact(BFI) Queens Tower, Delflandlaan 1, 1062 EA Amsterdam, the Netherlands Mr. Sandeep Nailwal, Chairman sandeep@blockchainforimpact.nl 9819989954  
 
Primary Sponsor  
Name  Tata Medical Center 
Address  14 MAR (E-W), New Town, Rajarhat, Kolkata 700 160, West Bengal, India.  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjoy Chatterjee  Department of Radiation Oncology, Tata Medical Centre  14 MAR (E-W), New Town, Rajarhat, Kolkata 700 160, West Bengal, India.
Kolkata
WEST BENGAL 
9038161825

chatterjee72@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
TATA MEDICAL CENTER - INSTITUTIONAL REVIEW BOARD  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Female 
Details  To be included in the trial the patient must:
1.Have given written informed consent to participate for the study according to national/local regulations
2. Be aged over 18 years’ old
3. ECOG performance status 0, 1 or 2
4. Patient with histological diagnosis of AJCC Stage 1, 2, 3 or 4 invasive breast cancer (the presence of high grade DCIS is acceptable), including new loco-regional relapse or new metastatic lesion.
5. Patients scheduled for a biopsy/surgical procedure of the new lesion or fresh tissue available for research
 
 
ExclusionCriteria 
Details  Presence of any psychological, family, sociological or geographic condition potentially hampering compliance with the study protocol and follow-up schedule. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Main outcome:
Proportion of patients that receive personalised treatment based on genomic results.


 
5 years 
 
Secondary Outcome  
Outcome  TimePoints 
1.To evaluate the impact of genome-driven personalised medicine on breast cancer outcomes at 3 years in a non-selective, real-world setting.
2.To assess the effect of a genomic profiling programme on the identification of patients for clinical trials inclusion in a breast cancer population of all stages of disease.
3.To describe the influence of WGS on categories of clinical management: surgery; referral to clinical genetics; genomic-directed therapy change; genomic-directed toxicity management change; genomic-guided recommendation for future therapy.
4.To characterise molecular profiles or mutation signatures of breast cancer patients (both tumour and germline) with subsequent stratification of patients, and correlation of these profiles with clinical outcomes.
4.To ascertain the TME on tissue blocks and study its associations to the various molecular subtypes
 
5 years 
 
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)   01/12/2025 
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="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Patients recruited to this Pilot study will have the whole genome of the tumor and cells sequenced and data stored in database.  Treatment, demographic and clinical outcomes data will be collected and then clinical outcomes followed up for a minimum of 3 years (or until death) and correlated with the molecular profiles generated. The whole genome sequencing (WGS) data generated will allow classification into both prognostic risk groups and also potentially identify molecular drivers of breast cancer (e.g. CCND1, PAK1, ERBB2) and molecular profiles predictive of treatment response or non-response. We will store the RNA during the lifetime of the study from the patients where genome is sequenced, and we will explore the feasibility of including these results in clinical reports at a later stage. We will also investigate mutation signatures associated with prediction of treatment response to chemotherapy and also targeted agents.

This will be a single-centre study in Tata Medical Center, Kolkata with a sample size of 200 patients with breast cancer. Patients will be followed-up for a minimum of 5 years (or until death) from the date they receive their genomic results.

The primary objective is to evaluate the clinical feasibility and clinical utility of Whole Genome Sequencing (WGS) in the clinical management of breast cancer patient, in real world setting

 
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