Pasireotide LAR Administration in Lymphocele Prevention After Axillary Node Dissection for Breast Cancer
Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
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.