NCT01717131.

Trial name or title	NCT01717131/Institut Paoli‐Calmettes
Methods	Study design: RCT Country: France
Participants	Inclusion criteria: patients aged ≥ 18 years with (histologically or cytologically (by fine‐needle biopsy)) proven, invasive (unifocal tumour, TI‐T2 (up to 5 cm, clinical or imagery)) breast cancer, clinically N0 and M0, who have received no previous therapy (neoadjuvant or hormone therapy), for whom conservative surgery with SLN technique is feasible from the start in terms of carcinoembryology, and who are affiliated with a social security system of benefiting from such a system. The clinicaltrials.gov record further states, "All patients with lymph node involvement (GS+), whatever the size of the metastasis (macro‐metastasis, cellular cluster or isolated tumour cells)". Exclusion criteria: tumour > 5 cm, indication of neoadjuvant therapy by chemotherapy or hormone therapy, history of breast cancer (ipsilateral, i.e. recurrence, or contralateral breast, history of any invasive cancer other than a past cutaneous cancer correctly treated, initial metastatic disease known, presence of clinical axillary adenopathy, contraindication to surgical excision, contraindication to the SLN technique, pregnant women, women of child‐bearing potential, lactating women, patients deprived of liberty or under supervision of a guardian, impossibility to undergo medical examination of the study for geographical, social or psychological reasons
Interventions	ALND vs no ALND
Outcomes	Disease‐free survival, axillary recurrence rate, overall survival
Starting date	2012
Contact information	Dominique Genre and Sandra Cournier, +33 0491223778, bec@ipc.unicancer.fr
Notes