BREAST CANCER MedDRA version: 12.1 Level: LLT Classification code 10006187 Term: Breast cancer
Conditions
Interventions
Product Name: PASIREOTIDE LAR
Product Code: SOM 230 C
Pharmaceutical Form: Powder for solution for injection
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Intr
Sponsors
Alliance pour la recherche en cancérologie
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the efficacy of a preoperative prolonged release pasireotide injection in the reduction in the incidence of symptomatic, postoperative axillary lymphoceles following mastectomy-axillary node dissection. ;Secondary Objective: to evaluate the efficacy of prolonged release pasireotide on: - the duration of postoperative drainage - the daily drainage volume - the total drainage volume - the number of repeated lymphocele aspirations and the volume. - the total volume of lymph aspirated - the incidence of postoperative febrile episodes - the length of the hospital stay - the length of time to onset of adjuvant chemotherapy - to evaluate the safety of prolonged release pasireotide ;Primary end point(s): The primary endpoint of this study is the ratio of patients who did not have symptomatic, postoperative axillary lymphoceles defined as the absence of aspiration or a unique or iterative aspirations global volume of lymphoceles inferior to 60cc inclusive (=) in the 28 days after the intervention or a systematic aspiration volume at the 28th day inferior to 120cc inclusive (=) | — |
Countries
France
Outcome results
None listed