Axillary Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node

  • STATUS
    Recruiting
  • End date
    Jul 24, 2028
  • participants needed
    3000
  • sponsor
    Institut Paoli-Calmettes
Updated on 24 January 2021
endocrine therapy
metastasis
hormone therapy
tumor cells
sentinel node

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 IdentifierNCT01717131
SponsorInstitut Paoli-Calmettes
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have Invasive Breast Cancer?
Do you have any of these conditions: Do you have Invasive Breast Cancer??
\- Patient aged 18 years and above
\- Patient with invasive breast cancer histologically proven or cytologically proven by fine needle biopsy
\- Patient with a unifocal tumor T0 - T1 - T2 up to 5 cm (clinical or in imagery), without previous therapy (neoadjuvant chemotherapy or hormone therapy)
\- Patient with clinical N0 status
\- Absence of clinically detectable metastases known
- Patients for whom conservative surgery with sentinel lymph node (SLN)
technique is feasible from the start in terms of carcinologic
-All patients with lymph node involvement (GS+), whatever the size of the
metastasis (macro-metastasis, micro-metastasis, cellular cluster or isolated
tumor cells)
- Patient affiliated to a social security system or benefiting from such a
system
- Signed consent to participate

Exclusion Criteria

\- Tumor of more than 5 cm
\- Indication of neoadjuvant therapy by chemotherapy or hormone therapy
\- History of breast cancer (ipsilateral, ie recurrence, or contralateral breast)
\- History of any other invasive cancer other than a past cutaneous cancer correctly treated
\- Initial metastatic disease known
\- Presence of clinical axillary adenopathy
\- Contra-indication to surgical excision
\- Contra-indication to the SLN technique
\- Pregnant women, of child-bearing potential, or lactating women
- Patient deprived of liberty or under supervision of a guardian
- Impossibility to undergo medical examinations of the study for
geographical, social or psychological reasons
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