Pasireotide LAR Administration in Lymphocele Prevention After Axillary Node Dissection for Breast Cancer

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

The principal morbidity following axillary node dissection within the scope of breast cancer surgery is the post-operative development of lymphocele. According to the literature, incidence can vary from 4 to 89% depending on the type of surgery, whether or not a drain is inserted or a compression dressing applied and the time at which the drain is removed… In our experience, the incidence is 40% [IGR (Gustave Roussy Institute) data focusing on 70 patients between November 2008 and February 2009]

Encouraging results in terms of reducing postoperative lymphoceles as well as drainage duration and volume using Octreotide have been recorded in two recent studies. A new molecule developed by Novartis Laboratories, namely pasireotide, is a somatostatin analog possessing strong affinity for several somatostatin receptors (30 to 40 times greater for sst1 and sst5, 5 times greater for sst3 and equivalent for sst2)

The purpose of this trial is to assess the efficacy of a pre-surgical injection of pasireotide LAR in reducing the postoperative incidence of symptomatic lymphoceles following axillary node dissection.

The secondary objectives are to assess 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 hospital stay, and the length of time to onset of adjuvant chemotherapy. It is also to assess the safety of prolonged release pasireotide.

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance Pour La Recherche en Cancerologie
• Treatments: Pasireotide

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.

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.