Axillary Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node
Invasive Breast Cancer
About this trial
This is an interventional treatment trial for Invasive Breast Cancer focused on measuring Invasive breast cancer
Eligibility Criteria
Inclusion Criteria:
- - 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,
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:
- - 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
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.
Sites / Locations
- Gilles HOUVENAEGHEL, PHDRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Surgery for standard axillary node dissection
No axillary lymph node dissection
Standard axillary dissection
No surgery of axillary lymph node In this study, the absence of surgery is the experimental arm (non-inferiority trial)