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
Inclusion Criteria:
1. - Patient aged 18 years and above,
2. - Patient with invasive breast cancer histologically proven or cytologically proven
by fine needle biopsy,
3. - Patient with a unifocal tumor T0 - T1 - T2 up to 5 cm (clinical or in imagery),
without previous therapy (neoadjuvant chemotherapy or hormone therapy),
4. - Patient with clinical N0 status,
5. - Absence of clinically detectable metastases known,
6- Patients for whom conservative surgery with sentinel lymph node (SLN) technique is
feasible from the start in terms of carcinologic,
7 -All patients with lymph node involvement (GS+), whatever the size of the metastasis
(macro-metastasis, micro-metastasis, cellular cluster or isolated tumor cells),
8 - Patient affiliated to a social security system or benefiting from such a system,
9 - Signed consent to participate.
Exclusion Criteria:
1. - Tumor of more than 5 cm
2. - Indication of neoadjuvant therapy by chemotherapy or hormone therapy
3. - History of breast cancer (ipsilateral, ie recurrence, or contralateral breast)
4. - History of any other invasive cancer other than a past cutaneous cancer correctly
treated
5. - Initial metastatic disease known
6. - Presence of clinical axillary adenopathy
7. - Contra-indication to surgical excision
8. - Contra-indication to the SLN technique
9. - Pregnant women, of child-bearing potential, or lactating women
10- Patient deprived of liberty or under supervision of a guardian
11- Impossibility to undergo medical examinations of the study for geographical, social or
psychological reasons.