A randomized double-blind study, performed with the use of placebo, to assess the efficacy of the drug LF-PB at different doses to treat linforrea after removal of axillary lymph nodes in patients with breast cancer.

Conditions: Patient undergoing breast surgery with axillary lymph node dissection.
MedDRA version: 15.0Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disorders
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2012-000114-10-IT

Lead Sponsor: CHEMI S.P.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

1.Female aged 18 to 80 years inclusive
2.Body mass index =18 kg/m2
3.Signed informed consent form
4.Diagnosis of breast cancer (BC)
5.Undergoing breast surgery with axillary lymph node dissection
Note: Collagen powder or fibrin sealant are not permitted.
6.Negative serum pregnancy test for women of childbearing potential
Note: Female patients of childbearing potential should be advised to use adequate contraception if necessary during treatment with octreotide.
7.Aspartate aminotransferase and alanine aminotransferase <1.5 x the upper limit of normal
8.Ability to fully understand all study procedures and to comply with study visits scheduled for the duration of the study
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1. Presence of any of the following conditions: a. Previous axillary surgery b. Previous chemotherapy c. Previous neoadjuvant therapy d. Recurrent BC e. Diabetes f. Cholelithiasis g. Hypothyroidism h. Hepatitis i. Pregnant or lactating j. Human immunodeficiency virus or hepatitis B or C by screening serology 2. History of radiotherapy 3. History of anaphylaxis to study drug 4. Ascertained or presumptive hypersensitivity to the active principle and/or the ingredients of the study drug formulation 5. QTc interval extension at screening or baseline > 450 msec (as the mean of 3 consecutive readings 5 minutes apart) 6. Presence of any disease or use of concomitant medication known to increase the QT interval (see Appendix 2 for a list of such compounds) 7. Clinically significant or relevant abnormal medical history, vital sign, physical examination, electrocardiogram (ECG), or laboratory evaluation finding 8. Current or recurrent disease that could affect the action, absorption, or disposition of the study drug 9. Current or recurrent disease that could affect the results of the clinical or laboratory assessments required for the study 10. Corticosteroids treatment within 1 month prior to surgery