| 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
|
|
|
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
|
|
|
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. |