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CTRI Number  CTRI/2024/09/073710 [Registered on: 10/09/2024] Trial Registered Prospectively
Last Modified On: 02/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Study investigating a surgical technique called Targeted Axillary Dissection (TAD) in patients with breast cancer who had received chemotherapy 
Scientific Title of Study   Targeted Axillary Dissection (TAD) with radiological guidance in post-chemotherapy breast cancer patients: A pilot 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  Nivedita Sharma 
Designation  Assistant Professor 
Affiliation  AIIMS, Jodhpur 
Address  Department of Surgical Oncology OPD 5th Floor, A-Block, AIIMS Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  7034635141  
Fax    
Email  nivsha1985@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nivedita Sharma 
Designation  Assistant Professor 
Affiliation  AIIMS, Jodhpur 
Address  Department of Surgical Oncology OPD 5th Floor, A-Block, AIIMS Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  7034635141  
Fax    
Email  nivsha1985@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nivedita Sharma 
Designation  Assistant Professor 
Affiliation  AIIMS, Jodhpur 
Address  Department of Surgical Oncology OPD 5th Floor, A-Block, AIIMS Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  7034635141  
Fax    
Email  nivsha1985@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences, Marudhar Industrial Area, 2nd Phase, MIA 1st phase, Basni, Jodhpur, Rajasthan, India. PIN-342003 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Jodhpur 
Address  Marudhar Industrial area, 2nd phase, MIA, 1st phase Basni, Jodhpur, PIN-342005 
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 Nivedita Sharma  All India Institute of Medical Sciences, Jodhpur  Room No 509, Block A, Department of Surgical Oncology, OPD Block, AIIMS Jodhpur, Marudhar Industrial Area, 1st phase Basni, Jodhpur 342005
Jodhpur
RAJASTHAN 
7034635141

nivsha1985@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Jodhpur  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  N/A  N/A 
Comparator Agent  N/A  N/A 
Intervention  Targeted Axillary Dissection  Targeted Axillary dissection guided by pre-NACT axillary node clipping and peri-operative radiological guidance  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  • Patients with cT1-3 N1 M0 carcinoma breast irrespective of histology or hormonal receptor status scheduled to receive neoadjuvant chemotherapy (NACT)
• Patients with FNAC or biopsy proven positive axillary lymph node

 
 
ExclusionCriteria 
Details  • Patients with previous ipsilateral axillary surgery
• Patients with previous radiotherapy to ipsilateral axilla
• Patients allergic to methylene blue dye or fluorescein dye
• Patients who have palpable axillary lymph nodes on clinical examination post-NACT
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the identification rate of TAD with ultrasound guidance in post-NACT carcinoma breast patients  Intra-operative 
 
Secondary Outcome  
Outcome  TimePoints 
To determine Technical Failure Rate (TFR) of clipped node biopsy – percentage of patient in which clipped node could not be identified and removed.  Intra-operative 
To determine False Negative rate (FNR) of TAD with ultrasound guidance in post-NACT carcinoma breast patients  Perioperative 
To the evaluate the concordance between clipped lymph node (CLN) and sentinel lymph node (SLN)  Intra-operative 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/10/2024 
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="2"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [nivsha1985@gmail.com].

  6. For how long will this data be available start date provided 01-06-2027 and end date provided 01-06-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

 In breast cancer patients, the optimal surgical management of the axilla has been controversial especially in node positive patients. Until recently, axillary lymph node dissection (ALND) was considered standard in such patients. ALND not only provided accurate staging by assessing pathological lymph node status but also ensured locoregional control as well as helped guiding systemic therapy. Nevertheless, it is associated with higher morbidity in terms of lymphedema, shoulder syndrome, recurrent seromas, sensory loss in arm etc. This gradually led to identification of sentinel lymph node biopsy (SLNB) as a feasible alternative with much lesser morbidity. Though SLNB is now considered standard of care in node negative early breast cancer, its role in initially node positive patients who achieve complete clinical axillary response with neoadjuvant chemotherapy (NACT) is still evolving. Initial trials on SLNB in node positive breast cancer patients receiving NACT had high FNR of 13-15%. Attempts to decrease the FNR further, led to evolution of Targeted Axillary Dissection (TAD) which involves marking of suspected lymph node prechemotherapy and then localizing and removing that node along with other sentinel lymph nodes. Various methods of marking and localising the suspected nodes have been reported in literature, but there is lack of consensus on the most appropriate or feasible technique.  While few techniques like radioactive seed localisation has good identification rate, difficulty in procurement, strict regulatory guidelines of use and high cost on radioactive isotopes has prevented its widespread adoption. Also, there is lack of data on targeted axillary dissection from Indian subcontinent.

Through this study, we aim to assess feasibility and performance of targeted axillary dissection utilizing pre-operative and intra-operative ultrasound guidance in node positive breast cancer patients who achieve complete axillary response after NACT. Once the feasibility and accuracy of this technique is established, it will provide a cost-effective option of performing TAD in growing economies as well as resource constraint settings. Also, this study will further guide as to design prospective trial to study long term oncological outcomes of TAD and SLNB in this subset of patients. 

Research Hypothesis

Clipping the positive lymph node pre-NACT and ensuring removal of that node along with other sentinel lymph nodes during SLNB using preoperative/ intraoperative ultrasound should decrease the FNR of SLNB in post-NACT carcinoma breast patients.


 
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