Lymphorrhea
Conditions
Brief summary
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.
Interventions
DRUGLF-PB and Placebo
DRUGPlacebo
DRUGLF-PB
Sponsors
Chemi S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Female aged 18 to 80 years inclusive 2. Body mass index (BMI) ≥18 kg/m2 3. Signed informed consent form 4. Diagnosis of BC 5. Undergoing breast surgery with ALND Note: Collagen powder or fibrin sealant are not permitted. 6. 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. 7. AST and alanine aminotransferase ALT \<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 on the same armpit undergoing surgery in this study 2. Previous chemotherapy or radiotherapy within five years from study drug administration 3. Previous neoadjuvant therapy 4. Recurrent BC on the same breast undergoing surgery in this study 5. Diabetes 6. Cholelithiasis 7. 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. 8. Hepatitis 9. Pregnant or lactating 10. Human immunodeficiency virus or hepatitis B or C by screening serology 2. History of radiotherapy on the same breast or armpit undergoing surgery in this study. 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, 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| effect of LF-PB 10 mg, 20 mg, and 30 mg on time to resolution of lymphorrhea; | 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 | 12 weeks after surgery | Safety and tolerability of LF-PB |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| effects of LF-PB 10, 20, and 30 mg on the daily volume of lymph collected from the drain | 12 weeks after surgery | daily volume of lymph collected from the drain |
| number of complications related to lymphorrhea | 12 weeks after surgery | effect of LF-PB 10, 20 and 30 mg on complications related to lymphorrhea |
| 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 | PK parameters |
Other
| Measure | Time frame | Description |
|---|---|---|
| correlation between LF-PB exposures and efficacy after the administration of LF-PB 10 mg, 20 mg, and 30 mg | 12 weeks after surgery | correlation between exposure of the drug and efficacy |
Countries
Italy
Outcome results
None listed