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CTRI Number  CTRI/2025/11/098114 [Registered on: 26/11/2025] Trial Registered Prospectively
Last Modified On: 28/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Patient diagnosed with breast cancer recurrence and planned to repeat the surgery will be enrolled to evaluate the accuracy of a dual tracer method in detecting sentinel lymph nodes and understanding lymphatic drainage 
Scientific Title of Study   Validation of dual tracer Sentinel Lymph node biopsy in patients with non-metastatic in-breast tumour recurrence undergoing Re-surgery and study of lymphatic drainage pathways (SLR study) 
Trial Acronym  SLR Study  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shalaka Joshi 
Designation  Professor and Surgeon 
Affiliation  Tata Memorial Centre 
Address  Room no 1207, Homi Bhabha Building, Tata Memorial Hospital Dr Ernest Borges Road Parel Mumbai
Tata Memorial Hospital Dr Ernest Borges Road Parel Mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone  02224177198  
Fax    
Email  drshalakajoshi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shalaka Joshi 
Designation  Professor and Surgeon 
Affiliation  Tata Memorial Centre 
Address  Room no 1207, Homi Bhabha Building, Tata Memorial Hospital Dr Ernest Borges Road Parel Mumbai
Tata Memorial Hospital Dr Ernest Borges Road Parel Mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone  02224177198  
Fax    
Email  drshalakajoshi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shabina Siddique 
Designation  Scientific Officer D 
Affiliation  Tata Memorial Centre 
Address  Homi Bhabha Building, 1st floor, Room No, 116, Tata Memorial Hospital Dr Ernest Borges Road Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9833365170  
Fax    
Email  kgn_43@yahoo.co.in  
 
Source of Monetary or Material Support  
Tata Memorial Centre Dr Ernest Borges Road Parel Mumbai, Maharashtra, India 400012 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
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 Shalaka Joshi  Tata Memorial Centre  Tata Memorial Centre,HBB building, Breast OPD, Room no 104 Dr. Borges Road, Parel, Mumbai-400012
Mumbai
MAHARASHTRA 
02224177198

drshalakajoshi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Insitutional Ethics Committee Tata Memorial Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NO comparator group  All patients will have the same procedure. Hence no comparator group 
Intervention  SLN biopsy with clearance   SN biopsy with two dyes will be done and pathology assessment will be done on table during surgery and all patients will also have a complete clearance as per standard practice 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  1. All patients with histologically proven ipsilateral breast tumourrecurrence (non-metastatic) who have
undergone SLNB or low axillary sampling (LAS) or ALND in their index surgery.
2. IBTR patients undergoing upfront surgery or post-chemotherapy surgery (re-BCS or completion
mastectomy)
3. Above 18 years
4. ECOG 0-2
5. Able to give written informed consent
6. Fit for surgery 
 
ExclusionCriteria 
Details  1. Pregnant, lactating women
2. Patients allergic to methylene blue dye / radio colloid injection 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. False Negative Rate
 
After surgery  
 
Secondary Outcome  
Outcome  TimePoints 
1. Identification rate of SLNB
2. Identification of first echelon SNB after previous breast surgery
 
after surgery  
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   08/12/2025 
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="4"
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  

Breast cancer treatment and axillary (underarm lymph node) surgery have evolved over the years to become less extensive and more precise. Sentinel lymph node biopsy (SLNB) is now a standard method used to identify the first few lymph nodes that drain the breast and are most likely to contain cancer cells.

In some patients, breast cancer can recur in the same breast after the first surgery, known as ipsilateral breast tumour recurrence (IBTR). Managing the lymph nodes in such cases is challenging because prior surgery and radiotherapy may have altered the normal lymphatic drainage pathways. The standard treatment currently involves a complete axillary lymph node dissection (ALND), which can lead to higher rates of complications such as arm swelling (lymphedema).

This study, called the SLR study, aims to validate the use of a dual tracer technique (using a combination of radioactive tracer and blue dye) for identifying sentinel lymph nodes in patients with non-metastatic in-breast tumour recurrence who are undergoing repeat breast surgery. The study will also assess how lymphatic drainage pathways change after previous breast and axillary surgeries.

All eligible patients with confirmed non-metastatic breast cancer recurrence will undergo the dual tracer sentinel lymph node procedure, followed by standard axillary lymph node dissection. The study will evaluate the accuracy (false-negative rate) and identification rate of the repeat SLNB and will help improve understanding of lymphatic mapping in previously operated patients.

The results are expected to provide evidence on whether re-SLNB can safely replace full axillary clearance in selected patients and help reduce surgical morbidity while maintaining accurate staging.


 
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