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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Chemi S.p.A.
- 入组人数
- 114
- 试验地点
- 13
- 主要终点
- effect of LF-PB 10 mg, 20 mg, and 30 mg on time to resolution of lymphorrhea;
研究概览
简要总结
This is a phase II, multicenter, double-blind, double-dummy, parallel-group, placebo-controlled, study to evaluate LF-PB versus placebo in female patients with brest cancer who are undergoing breast surgery with axillary lymphnode dissection.
Recruited patients will be randomly assigned to one of the following treatment groups: Placebo, LF-PB 10 mg, LF-PB 20 mg and LF-PB 30 mg.
Mode of administration is single intramuscular (IM) injection so the treatments arms are as follows:
Placebo: 2 injections of placebo LF-PB 10 mg: 2 injections = placebo + 10 mg LF-PB 20 mg: 2 injections = placebo + 20 mg LF-PB 30 mg: 2 injections = 10 mg + 20 mg
The study will randomize a total of 120 patients (30 per arm) in about 10 Italian Sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged 18 to 80 years inclusive
- •Body mass index (BMI) ≥18 kg/m2
- •Signed informed consent form
- •Diagnosis of BC
- •Undergoing breast surgery with ALND Note: Collagen powder or fibrin sealant are not permitted.
- •Negative serum pregnancy test for women of childbearing potential Note: Female patients of child-bearing potential should be advised to use adequate contraception if necessary during treatment with octreotide.
- •AST and alanine aminotransferase ALT <1.5 x the upper limit of normal
- •Ability to fully understand all study procedures and to comply with study visits scheduled for the duration of the study.
排除标准
- •Presence of any of the following conditions:
- •Previous axillary surgery on the same armpit undergoing surgery in this study
- •Previous chemotherapy or radiotherapy within five years from study drug administration
- •Previous neoadjuvant therapy
- •Recurrent BC on the same breast undergoing surgery in this study
- •Cholelithiasis
- •Hypothyroidism. If patient is being administered Euritox/ 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
- •Human immunodeficiency virus or hepatitis B or C by screening serology
- •History of radiotherapy on the same breast or armpit undergoing surgery in this study.
- •History of anaphylaxis to study drug
- •Ascertained or presumptive hypersensitivity to the active principle and/or the ingredients of the study drug formulation
- •QTc interval extension 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 (see Appendix 2 for a list of such compounds)
- •Clinically significant or relevant abnormal medical history, vital sign, physical examination, ECG, or laboratory evaluation finding
- •Current or recurrent disease that could affect the results of the clinical or laboratory assessments required for the study
研究组 & 干预措施
LF-PB 20 mg
2 IM injections = placebo + 20 mg
干预措施: LF-PB and Placebo (Drug)
LF-PB 10 mg
2 IM injections = placebo + 10 mg
干预措施: LF-PB and Placebo (Drug)
LF-PB 30 mg
2 IM injections = 10 mg + 20 mg
干预措施: LF-PB (Drug)
Placebo
2 IM injections of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
effect of LF-PB 10 mg, 20 mg, and 30 mg on time to resolution of lymphorrhea;
时间窗: 12 weeks post surgery
End of lymphorrhea will be declared when the lymph volume measured by the patient is \< 50 ml/day in 2 consecutive days.
number of AEs and laboratory, ECG, vital sign abnormalities of LF-PB 10 mg, 20 mg, and 30 mg
时间窗: 12 weeks after surgery
Safety and tolerability of LF-PB
次要结局
- effects of LF-PB 10, 20, and 30 mg on the daily volume of lymph collected from the drain(12 weeks after surgery)
- number of complications related to lymphorrhea(12 weeks after surgery)
- PK profile (Cmax, Tmax, AUC0-t and possibly AUC0-inf and T1/2) of LF-PB 10, 20 and 30 mg(12 weeks after surgery)