Ignite Creation Date:
2024-07-17 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06464341
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-12
Brief Title:
Nodal Burden and Nodal Recurrence in Patients With Isolated Tumor Cells After Neoadjuvant Chemotherapy Treated With Axillary Dissection or Nodal Radiation the OPBC-05EUBREAST-14RICARO Study
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Nodal Burden and Nodal Recurrence in Patients With Isolated Tumor Cells After Neoadjuvant Chemotherapy Treated With Axillary Dissection or Nodal Radiation the OPBC-05EUBREAST-14RICARO Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICARO
Brief Summary:
The purposes of this multicenter retrospective cohort study are to determine the residual nodal burden in patients with isolated tumor cells detected in the SLN or the clipped node after NAC and to determine oncologic outcomes in this group of patients after ALND or nodal RT or observation
Detailed Description:
In the context of upfront surgery the extent of disease in the sentinel lymph nodes SLNs significantly predicts the chances of additional non-SLN metastases during axillary lymph node dissection ALND For patients with minimal SLN disease isolated tumor cells ITCs and micrometastases the probability of further non-SLN metastases is between 10-20 In contrast for patients with macrometastases the risk increases to 27-33
In patients undergoing neoadjuvant chemotherapy NAC those with positive SLNs exhibit a greater residual nodal burden compared to those treated with upfront surgery For patients with remaining micro- or macrometastases post-NAC additional positive lymph nodes are found in over 60 of ALND specimens regardless of receptor subtype Consequently ALND remains the standard care for any residual nodal disease after NAC
Residual ITCs after NAC are present in about 15 of all patients undergoing NAC There is limited data on the likelihood of discovering additional positive lymph nodes in this group with fewer than 35 documented cases examining residual nodal burden Therefore the benefit of ALND for minimal residual disease is uncertain and axillary management for patients with nodal ITCs is not standardized Although omitting ALND reduces arm morbidity identifying residual nodal disease can influence adjuvant therapy recommendations Despite the lack of consensus on the oncologic safety of omitting ALND in this group care patterns indicate a growing adoption of this approach Given the rarity of this clinical scenario and the absence of forthcoming prospective studies this study utilized real-world data from a large international cohort to determine the incidence of residual non-SLN involvement in patients with ITCs in the SLNs post-NAC and to compare clinical outcomes in patients with and without ALND as definitive axillary treatment
In patients undergoing neoadjuvant chemotherapy NAC those with positive SLNs exhibit a greater residual nodal burden compared to those treated with upfront surgery For patients with remaining micro- or macrometastases post-NAC additional positive lymph nodes are found in over 60 of ALND specimens regardless of receptor subtype Consequently ALND remains the standard care for any residual nodal disease after NAC
Residual ITCs after NAC are present in about 15 of all patients undergoing NAC There is limited data on the likelihood of discovering additional positive lymph nodes in this group with fewer than 35 documented cases examining residual nodal burden Therefore the benefit of ALND for minimal residual disease is uncertain and axillary management for patients with nodal ITCs is not standardized Although omitting ALND reduces arm morbidity identifying residual nodal disease can influence adjuvant therapy recommendations Despite the lack of consensus on the oncologic safety of omitting ALND in this group care patterns indicate a growing adoption of this approach Given the rarity of this clinical scenario and the absence of forthcoming prospective studies this study utilized real-world data from a large international cohort to determine the incidence of residual non-SLN involvement in patients with ITCs in the SLNs post-NAC and to compare clinical outcomes in patients with and without ALND as definitive axillary treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None