Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518135
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients With Initial cN1 Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients With Initial cN1 Breast Cancer a Prospective Multicenter Single Arm Real World Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
SLNB has been recommended by domestic and foreign guidelines for patients with initial cN1 and NAC descending to ycN0 However the best technical path is still not very clear at present and the long-term tumor safety data is still insufficient Therefore it is necessary to further explore the optimal technical pathway and long-term tumor safety for SLNB in patients with initial cN1 and NAC downgrading to ycN0 in the real worldThis study will evaluate the optimized technical pathway and long-term tumor safety of SLNB in patients with initial cN1 and NAC downgrading to ycN0 in real-world studies
Detailed Description:
SLNB has been recommended by domestic and foreign guidelines for patients with initial cN1 and NAC descending to ycN0 However the best technical path is still not very clear at present and the long-term tumor safety data is still insufficient Therefore it is necessary to further explore the optimal technical pathway and long-term tumor safety for SLNB in patients with initial cN1 and NAC downgrading to ycN0 in the real worldThis study will evaluate the optimized technical pathway and long-term tumor safety of SLNB in patients with initial cN1 and NAC downgrading to ycN0 in real-world studies The main endpoint of the study was axillary recurrence free survival The secondary study endpoints were regional lymph node recurrence free survival disease-free survival overall survival incidence of postoperative upper limb lymphedema and patient quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None