Axillary Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node
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|ClinicalTrials.gov Identifier: NCT01717131|
Recruitment Status : Recruiting
First Posted : October 30, 2012
Last Update Posted : January 22, 2020
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
|Condition or disease||Intervention/treatment||Phase|
|Invasive Breast Cancer||Procedure: Surgery for standard axillary node dissection Other: No axillary lymph node dissection||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||July 2028|
|Estimated Study Completion Date :||July 2028|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01717131
|Contact: Dominique GENRE, MD||33 (0)4 91 22 37 firstname.lastname@example.org|
|Contact: Sandra COURNIER||33 (0)4 91 22 37 email@example.com|
|Gilles HOUVENAEGHEL, PHD||Recruiting|
|Marseille, France, 13009|
|Contact: Gilles HOUVENAEGHEL, PhD 33(0)491223778 firstname.lastname@example.org|
|Principal Investigator:||Gilles HOUVENAEGHEL, MD, PHD||Institut Paoli-Calmettes|