Pasireotide LAR Administration in Lymphocele Prevention After Axillary Node Dissection for Breast Cancer (SOM 230)

Inclusion Criteria:

• Female patient aged 18 years or over.
• Patient understands French.
• Patient covered by the French national health insurance system.
• Any female patient scheduled for breast surgery with mastectomy and axillary node dissection indicated at the pre-surgical stage.

Exclusion Criteria:

• Patient under the age of 18 years.
• Patient who does not understand French.
• Patient not covered by the French national health insurance system.
• Patient exhibiting one or more contraindications to anesthesia and surgery.
• Patient with a contra-indication to pasireotide
• Refusal by the patient
• Scheduled sentinel node procedure
• Abnormal coagulation or curative anticoagulant treatment
• Women of child-bearing potential without effective contraception,
• Pregnant or breast-feeding women
• Poorly controlled diabetes (HbA1c > 8%)
• History of radiotherapy
• Recurrent breast cancer
• Patient with a congestive cardiac insufficiency (NYHA category III or IV), an instable angina pectoris, sustained ventricular tachycardia or ventricular fibrillation episodes or history of myocardial infarction during the last 6 months.
• Patient presenting an extension of QT interval (QT corrected according to the Fridericia formula (QTcF)) at the screening or baseline (predose) > 450msec
• History of syncope or family history of sudden death or significant cardiac arrhythmia
• Risk factors for torsades de pointes: hypokaliaemia, hypomagnesaemia, known structural or ischaemic cardiac disease, bradycardia (HR<55/min) or high grade AV block
• Concomitant disease that could prolong QT or increase exposure to the study medication including dehydration, renal or hepatic impairment
• Concomitant medication known to increase the QT interval
• Patient with an hepatic pathology such as cirrhosis, chronic hepatitis active or persistent, or an elevation of ALAT rate, ASAT rate twice higher than the normal superior limit (NSL)
• Patient having leucocytes < 3x109/L, Hb < 90% LIN, platelets < 100x109/L
• Patient having a pathology or medical history susceptible to interfere with the realization of the study or results evaluation according to the judgment of the investigator or the study monitor
• Patient participating to another clinical trial with another molecule in study during the month before the first dose
• Known oversensitivity to somatostatine analogs or another component of prolonged release pasireotide or prolonged release octreotide formulations.