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

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.