Axillary Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node
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- STATUS
- Recruiting
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- End date
- Jul 24, 2028
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- participants needed
- 3000
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- sponsor
- Institut Paoli-Calmettes
Summary
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
Details
| Condition | Invasive Breast Cancer |
|---|---|
| Treatment | Surgery for standard axillary node dissection, No axillary lymph node dissection |
| Clinical Study Identifier | NCT01717131 |
| Sponsor | Institut Paoli-Calmettes |
| Last Modified on | 24 January 2021 |
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