This trial is active, not recruiting.

Condition seroma
Treatments extended release of octreotide, extended release of placebo
Phase phase 2
Sponsor Chemi S.p.A.
Start date October 2015
End date May 2016
Trial size 48 participants
Trial identifier NCT02668588, LF-PB/14/05


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
extended release of octreotide
extended release of octreotide LF-PB 30 mg
1 intramuscular injection of extended release of octreotide 30 mg
(Placebo Comparator)
extended release of placebo
extended release of placebo Placebo
1 intramuscular injection of extended release of placebo

Primary Outcomes

Incidence of seromas requiring an aspiration
time frame: Day 28 post surgery

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

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
Principal investigator Paolo Carcoforo, Prof.
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).
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Chemi S.p.A..