Axillary Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node
Data from cohorts, prospective studies and one randomized trial (ASCOG Z0011) support the hypothesis that omission of additional axillary dissection in case of positive sentinel node has a limited impact on overall survival and relapse free survival. However, these data are not sufficient enough to recommend, as a standard of care, to avoid axillary dissection in case of positive sentinel node. The ASCOG Z0011 trial has been closed before the end of inclusions and the predefined non inferiority margin was found to be too large (5% difference at 5 years for primary endpoint).
Prospective randomized trial is then urgently mandatory before omission of axillary node dissection becomes a usual practice without a sufficient scientific level of proof. Indeed, in several reviews, the rate of omission of axillary node dissection in case of micrometastasis increased (Bilimoria) despite any strong proof has been demonstrated.
The omission of axillary node dissection in case of positive sentinel node may have strong practical impacts on patients but also on medical and economical aspects: in avoiding a prolonged hospitalisation, secondary morbidities due to axillary dissection requiring secondary care and their costs, as well as costs for secondary axillary dissection (14 to 25% in case of positive sentinel node) and finally shortening surgery duration.
The main investigator propose a Non Inferiority Randomized Multicenter Phase III Trial of Axillary Node Dissection Versus no Axillary Node Dissection in Case of Positive Sentinel Lymph Node in Invasive Breast Cancer
|Invasive Breast Cancer||Procedure: Surgery for standard axillary node dissection Other: No axillary lymph node dissection||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Non Inferiority Randomized Multicenter Phase III Trial of Axillary Node Dissection Versus no Axillary Node Dissection in Case of Positive Sentinel Lymph Node in Invasive Breast Cancer|
- Disease Free survival [ Time Frame: Time to relapse or progression up to 10 years ]time from randomization to relapse or death.
- axillary recurrence rate [ Time Frame: Time to local relapse up to 10 years ]Estimate the incidence of axillary recurrence after surgery followed by axillary dissection or after surgery alone.
- Overall survival [ Time Frame: Time to death up to 10 years ]Time from randomization to date of death
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||July 2025|
|Estimated Primary Completion Date:||July 2025 (Final data collection date for primary outcome measure)|
Active Comparator: Surgery for standard axillary node dissection
Standard axillary dissection
|Procedure: Surgery for standard axillary node dissection|
Experimental: No axillary lymph node dissection
No surgery of axillary lymph node In this study, the absence of surgery is the experimental arm (non-inferiority trial)
Other: No axillary lymph node dissection
No surgery on axillary lymph node
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717131
|Contact: Dominique GENRE, MD||33 (0)4 91 22 37 email@example.com|
|Contact: Sandra COURNIER||33 (0)4 91 22 37 firstname.lastname@example.org|
|Gilles HOUVENAEGHEL, PHD||Recruiting|
|Marseille, France, 13009|
|Contact: Gilles HOUVENAEGHEL, PhD 33(0)491223778 email@example.com|
|Principal Investigator:||Gilles HOUVENAEGHEL, MD, PHD||Institut Paoli-Calmettes|