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

CHEMI S.P.A.0 个研究点开始时间: 2012年10月11日最近更新: 2015年9月14日

试验速览

暂无简介。

•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

•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

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