Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072293
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2003-11-04
Brief Title:
Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases
Sponsor:
ETOP IBCSG Partners Foundation
Organization:
ETOP IBCSG Partners Foundation
Study Overview
Official Title:
A Randomized Trial Of Axillary Dissection Versus No Axillary Dissection For Patients With Clinically Node Negative Breast Cancer And Micrometastases In The Sentinel Node
Status:
COMPLETED
Status Verified Date:
2017-12
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:
23-01
Brief Summary:
RATIONALE Surgery to remove lymph nodes in the armpit in patients with sentinel lymph node micrometastases may remove cancer cells that have spread from tumors in the breast It is not yet known whether surgery to remove the primary tumor is more effective with or without axillary lymph node dissection
PURPOSE This randomized phase III trial is studying surgery and axillary lymph node dissection to see how well they work compared to surgery alone in treating women with node-negative breast cancer and sentinel lymph node micrometastases
PURPOSE This randomized phase III trial is studying surgery and axillary lymph node dissection to see how well they work compared to surgery alone in treating women with node-negative breast cancer and sentinel lymph node micrometastases
Detailed Description:
OBJECTIVES
Compare disease-free survival of women with clinically node-negative breast cancer with sentinel lymph node micrometastases treated with surgical resection with or without axillary dissection
Compare overall survival of patients treated with these regimens
Assess sites of recurrence particularly reappearance of disease in the undissected axilla
Assess long-term surgical complications in patients treated with these regimens
OUTLINE This is a multicenter study Patients are stratified according to participating center menopausal status pre- vs postmenopausal and preoperative sentinel node biopsy yes vs no Patients are followed every 4 months for 1 year every 6 months for 4 years and then annually thereafter
Compare disease-free survival of women with clinically node-negative breast cancer with sentinel lymph node micrometastases treated with surgical resection with or without axillary dissection
Compare overall survival of patients treated with these regimens
Assess sites of recurrence particularly reappearance of disease in the undissected axilla
Assess long-term surgical complications in patients treated with these regimens
OUTLINE This is a multicenter study Patients are stratified according to participating center menopausal status pre- vs postmenopausal and preoperative sentinel node biopsy yes vs no Patients are followed every 4 months for 1 year every 6 months for 4 years and then annually thereafter
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IBCSG 23-01 | OTHER | IBCSG | None |