Study for the LF-PB (30mg) efficacy evaluation on seroma incidence and duration after axillary dissection in patient with breast cancer

A multicentre, double blind, randomized placebo controlled trial to assess the effect of LF-PB on seroma formation in women with breast cancer undergoing Axillary Lymph Node Dissection - Seroma after axillary Lymph Node Dissection

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005289-31-IT

Enrollment

Registered

2020-01-21

Start date

2015-08-04

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Woman with Breast Cancer Undergoing Axillary Lymph Node Dissection MedDRA version: 20.0 Level: SOC Classification code 10005329 Term: Blood and lymphatic system disorders System Organ Class: 10005329 - Blood and lymphatic system disorders

Interventions

Product Name: LF-PB Product Code: LF-PB Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: OCTREOTIDE ACETATO

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Signed informed consent form; 2. Female aged = 18 years; 3. Undergone breast cancer surgery with axillary lymph node dissection during the current clinical trial; 4. Negative serum pregnancy test for women of childbearing potential; 5. Aspartate aminotransferase and alanine aminotransferase =65 years) yes F.1.3.1 Number of subjects for this age range 12

Exclusion criteria

Exclusion criteria: 1. Previous axillary surgery on the same armpit (sentinel lymph node surgery is not exclusionary); 2. Previous radiotherapy within five years from study drug administration on the same armpit undergoing surgery in this study; 3. Concomitant participation to other clinical trials; 4. Uncontrolled diabetes; 5. Cholelithiasis; 6. Human immunodeficiency virus or hepatitis B or C by screening serology; 7. Uncontrolled hypothyroidism: if patient is being administered Eutirox/ 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. Pregnant or lactating; 9. Ascertained or presumptive hypersensitivity to the active principle and/or the ingredients of the study drug formulation; 10. Corrected QT (using the Bazett formula, QTc) interval 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; 11. Clinically significant or relevant abnormal medical history, vital sign, physical examination or laboratory evaluation finding; 12. Corticosteroid treatment on a long-term basis. Acute use of corticosteroids to prevent hypersensitivity reactions before surgery is not considered an exclusion criterion; 13. Current or recurrent disease that could affect the results of the clinical or laboratory assessment required for the study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effect of LF-PB 30 mg versus placebo on seroma incidence after ALND. To assess the safety and tolerability of LF-PB 30mg. ; Secondary Objective: To assess the effect of LF-PB 30 mg versus placebo on seroma duration, number of aspirations and amount of fluid aspirated from seroma. To assess the pharmacokinetic profile of LF-PB 30mg. ;Timepoint(s) of evaluation of this end point: 28 days; Primary end point(s): The primary endpoint of this trial is the incidence of seromas requiring an aspiration occurred by day 28. A drain will be positioned in the axilla at surgery time and will be removed 24 hours after surgery. Starting from Visit 2 (day 3), each subject will undergo an echography at the operated axilla at every scheduled visit till Visit 7 (Day 28) or until seroma resolution, whichever occurs first. After the Visit 7 (Day 28) echography will be performed only if clinically indicated. In case of seroma presence the investigator will decide if an aspiration is required; the decision will be based on the clinical investigator’s evaluation (e.g. due to patient’s discomfort). In case of aspiration, the subject with seroma will be considered amenable for the statistical analysis of seroma incidence. Safety and tolerability will be evaluated on the number of AEs and laboratory, ECG and vital sign abnormalities.	—

Measure

Time frame

Main Objective: To assess the effect of LF-PB 30 mg versus placebo on seroma incidence after ALND. To assess the safety and tolerability of LF-PB 30mg. ; Secondary Objective: To assess the effect of LF-PB 30 mg versus placebo on seroma duration, number of aspirations and amount of fluid aspirated from seroma. To assess the pharmacokinetic profile of LF-PB 30mg. ;Timepoint(s) of evaluation of this end point: 28 days; Primary end point(s): The primary endpoint of this trial is the incidence of seromas requiring an aspiration occurred by day 28. A drain will be positioned in the axilla at surgery time and will be removed 24 hours after surgery. Starting from Visit 2 (day 3), each subject will undergo an echography at the operated axilla at every scheduled visit till Visit 7 (Day 28) or until seroma resolution, whichever occurs first. After the Visit 7 (Day 28) echography will be performed only if clinically indicated. In case of seroma presence the investigator will decide if an aspiration is required; the decision will be based on the clinical investigator’s evaluation (e.g. due to patient’s discomfort). In case of aspiration, the subject with seroma will be considered amenable for the statistical analysis of seroma incidence. Safety and tolerability will be evaluated on the number of AEs and laboratory, ECG and vital sign abnormalities.

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Secondary

Measure	Time frame
Secondary end point(s): PK parameters (at least Cmax, Tmax, AUC0-X and t1/2) ;Timepoint(s) of evaluation of this end point: after 30 mg LF-PB single-dose administration.	—

Countries

Italy

Contacts

Public ContactClinical Research and Development

Italfarmaco S.p.A

p.bettica@italfarmaco.com+39 02 6443 2520

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026