A Randomized, Double-Blind, Double Dummy, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy of LF-PB 10 mg, 20 mg, and 30 mg to Treat Lymphorrhea Post Axillary Dissection in Breast Cancer
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
Exclusion Criteria:
1. Presence of any of the following conditions:
1. Previous axillary surgery
2. Previous chemotherapy
3. Previous neoadjuvant therapy
4. Recurrent BC
5. Diabetes
6. Cholelithiasis
7. Hypothyroidism
8. Hepatitis
9. Pregnant or lactating
10. 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. Corrected QT 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 results of the clinical or
laboratory assessments required for the study
9. Corticosteroids treatment within 1 month prior to surgery