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

• Status: Completed
• Trial end date: 2016-07-19
• Target enrollment: 0
• Participant gender: Female

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.

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

Details

• Lead Sponsor: Chemi S.p.A.
• Treatments: Octreotide

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.