Evaluation of the effect of pasireotide LAR administration in the lymphocele prevention after axillary node dissection for breast cancer - SOM 230

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.