Extended-release of Octreotide (LF-PB) for the Treatment of Seroma

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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).

Official Title
-----------------
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

Conditions
-----------------
Seroma

Intervention / Treatment
-----------------
* Drug: extended release of octreotide
* Drug: extended release of placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent form; Undergoing breast cancer surgery with axillary lymph node dissection during the current clinical trial; Negative serum pregnancy test for women of childbearing potential; Aspartate aminotransferase and alanine aminotransferase < 2 x the upper limit of normal; ECOG PS ≤ 1. Exclusion Criteria: Previous axillary surgery on the same armpit (sentinel lymph node surgery is not exclusionary); Previous radiotherapy within five years from study drug administration on the same armpit undergoing surgery in this study; Concomitant participation to other clinical trial; Uncontrolled diabetes; Cholelithiasis; Human immunodeficiency virus or hepatitis B or C by screening serology; Uncontrolled hypothyroidism: if patient is being administered Eutirox/ Levothyroxine (or analogues) and levels of T3, T4 and TSH are confirmed to be within the normal ranges at screening, the patient can be enrolled in this study; Pregnant or lactating; Ascertained or presumptive hypersensitivity to the active principle and/or the ingredients of the study drug formulation; Corrected QT (using the Bazett formula, QTc) interval at screening or baseline > 450 msec (as the mean of 3 consecutive readings 5 minutes apart); Presence of any disease or use of concomitant medication known to increase the QT interval; Clinically significant or relevant abnormal medical history, vital sign, physical examination or laboratory evaluation finding; Corticosteroid treatment on a long-term basis (i.e. treatment for more than 3 consecutive days); Current or recurrent disease that could affect the results of the clinical or laboratory assessment required for the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LF-PB 30 mg<br>extended release of octreotide | Drug: extended release of octreotide<br>* 1 intramuscular injection of extended release of octreotide 30 mg<br>* Other names: LF-PB 30 mg;|
| Placebo Comparator: Placebo<br>extended release of placebo | Drug: extended release of placebo<br>* 1 intramuscular injection of extended release of placebo<br>* Other names: Placebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 28 post surgery |