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

Phase 1

• 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; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2014-005289-31-IT
• Lead Sponsor: CHEMI S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-21
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 72

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 < 2x the upper limit of normal;
6.ECOG PS = 1;
7.Compliant with the required protocol.

Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified