| CTRI Number |
CTRI/2022/07/044461 [Registered on: 29/07/2022] Trial Registered Prospectively |
| Last Modified On: |
27/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Post-chemotherapy Axillary Conservation Surgery in breast cancer |
|
Scientific Title of Study
|
An open label, phase 3 randomized trial to evaluate the role of axillary conservation surgery in breast cancer patients post-neoadjuvant chemotherapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalaka P Joshi |
| Designation |
Professor and Surgeon in Surgical oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room no 1208 Homi Bhabha Building Tata Memorial Hospital Dr Ernest Borges road Parel Mumbai
Room no 103/104 First floor Homi Bhabha Building Tata Memorial Hospital Dr Ernest Borges road Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177198 |
| Fax |
|
| Email |
drjoshishalaka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalaka P Joshi |
| Designation |
Professor and Surgeon in Surgical oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room no 1208 Homi Bhabha Building Tata Memorial Hospital Dr Ernest Borges road Parel Mumbai
Room no 103/104 First floor Homi Bhabha Building Tata Memorial Hospital Dr Ernest Borges road Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177198 |
| Fax |
|
| Email |
drjoshishalaka@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shalaka P Joshi |
| Designation |
Professor and Surgeon in Surgical oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room no 1208 Homi Bhabha Building Tata Memorial Hospital Dr Ernest Borges road Parel Mumbai
Room no 103/104 First floor Homi Bhabha Building Tata Memorial Hospital Dr Ernest Borges road Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177198 |
| Fax |
|
| Email |
drjoshishalaka@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural Fund
Tata Memorial Hospital
Dr.Ernest Borges Marg
Parel,Mumbai 400012
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital Dr Ernest Borges Road Parel Mumbai 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 P Joshi |
Tata Memorial Centre |
Room no 103/104, Breast Private OPD,Tata Memorial Hospital Dr Ernest Borges road Parel Mumbai
Mumbai
MAHARASHTRA |
02224177198
drjoshishalaka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Tata Memorial Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Complete axillary dissection (level 1-3) |
Standard Arm: Patients on the standard arm will undergo total axillary clearance as per the standard of care |
| Intervention |
Only low axillary sampling OR sentinel node biopsy |
Patients on the experimental arm would undergo low axillary sampling OR sentinel node
biopsy instead of total axillary clearance as per the standard of care. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1 Histopathologically proven Breast Cancer
2 All patients with non metastatic breast cancer cT1 to 4 cN0 to 2 before beginning neoadjuvant
chemotherapy
3 Post NACT cN0
4 Patient voluntarily willing to give consent for study |
|
| ExclusionCriteria |
| Details |
1 Inflammatory breast cancer
2 Recurrent disease
3 Pregnant and lactating patients
4 Metastatic disease (including oligometastasis)
5 Pre-chemotherapy cN3 status (supraclavicular lymph node involvement and or internal
mammary lymph node involvement)
6 Women who have received prior chemo or hormonal therapy for breast cancer or co-existing or
previously treated non breast malignancy (such as hematolymphoid or ovarian cancer |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To show the non-inferiority of DFS between axillary conservative surgery (defined further as
low axillary sampling or equivalent sentinel node biopsy procedure) as compared to complete
axillary lymph node dissection in patients who are rendered node negative clinically after neoadjuvant chemotherapy |
At each follow up visit till completion of 5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To show a reduction in arm and shoulder morbidity with low axillary sampling
To assess the difference between the rate of regional nodal recurrence rate, local
recurrence, distal recurrence
To compare the overall survival in the two groups
To assess the RT dose delivered to axilla in both arms by proper dosimetric studies |
Assessment will be done at each followup visit till completion of 5 years of treatment completion |
|
|
Target Sample Size
|
Total Sample Size="2316"
Sample Size from India="2316"
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)
|
01/08/2022 |
| 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="13"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients with breast cancer are routinely treated with surgery for the breast and axilla. In the early node negative breast cancer setting, it is acceptable to carry out a sentinel node biopsy (SNB) or equivalent axillary staging procedure such as low axillary sampling (LAS) which has been shown to be not inferior with respect to long term survival as well as axillary nodal recurrence. Axillary conservation procedure is also likely to reduce the incidence of side effects of a complete axillary lymph node dissection. This procedure is acceptable only if axillary lymph nodes are negative on pathology. In our setting, almost 50% patients have positive nodes in the axilla. Nearly 40-50% patients whether locally advanced or operable with poor breast/tumour ratio receive neoadjuvant or pre-operative chemotherapy. In nearly 50-60% of such patients, axilla is rendered negative by chemotherapy. These patients who have good response to chemotherapy are ideal candidates to receive limited axillary surgery post-chemotherapy. However, the long-term effect of conserving the axilla is not yet proven in these patients. Hence, the study we are submitting will assess the feasibility of limited axillary nodal surgery in patients of breast cancer who have negative axillary nodes post-chemotherapy |