This is a multicentre, double blind, randomized placebo controlled trial to assess the effect of LF-PB on seroma formation in women with breast cancer undergoing Axillary Lymph Node Dissection (ALND). Recruited patients will be randomly assigned to receive LF-PB 30 mg or placebo.
The study will randomize between 24 and 72 subjects that received an ALND. A staged adaptive design is employed with two intermediate analyses and a final analysis. The first interim analysis at 24 treated subjects (at least 12 in each group) and the second at 48 treated subjects (at least 24 in each group).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
1 intramuscular injection of extended release of octreotide 30 mg
1 intramuscular injection of extended release of placebo
Az. Osp. Univ. Mater Domini
Catanzaro, Calabria, Italy
IRCCS Fondazione Pascale
Naples, Campania, Italy
Az. Osp. Univ. di Ferrara - Ospedale di Cona
Ferrara, Emilia-Romagna, Italy
Az.Osp. Univ. Policlinico di Modena
Modena, Emilia-Romagna, Italy
Incidence of seromas requiring an aspiration
Subjects will undergo an echography at the operated axilla at every scheduled visit till Day 28 or until seroma resolution, whichever occurs first. In case of seroma presence the investigator will decide if an aspiration is required; the decision will be based on the clinical investigator's evaluation. In case of aspiration, the subject with seroma will be considered amenable for the statistical analysis of seroma incidence.
Time frame: Day 28 post surgery
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Az. Osp. Univ. di Parma
Parma, Emilia-Romagna, Italy
IRCCS Azienda Ospedaliera Universitaria San Martino
Genoa, Liguria, Italy
Az. Osp. Univ. Città Della Salute e Della Scienza di Torino
Turin, Piedmont, Italy