NCT02668588

Brief Summary

This is 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 (ALND). Recruited patients will be randomly assigned to receive LF-PB 30 mg or placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2016

Completed
Last Updated

February 2, 2017

Status Verified

February 1, 2017

Enrollment Period

9 months

First QC Date

January 27, 2016

Last Update Submit

February 1, 2017

Conditions

Seroma

Outcome Measures

Primary Outcomes (1)

  • Incidence of seromas requiring an aspiration

    Subjects will undergo an echography at the operated axilla at every scheduled visit till Day 28 or until seroma resolution, whichever occurs first. 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. In case of aspiration, the subject with seroma will be considered amenable for the statistical analysis of seroma incidence.

    Day 28 post surgery

Study Arms (2)

LF-PB 30 mg

EXPERIMENTAL

extended release of octreotide

Drug: extended release of octreotide

Placebo

PLACEBO COMPARATOR

extended release of placebo

Drug: extended release of placebo

Interventions

extended release of octreotideDRUG

1 intramuscular injection of extended release of octreotide 30 mg

Also known as: LF-PB 30 mg
LF-PB 30 mg
extended release of placeboDRUG

1 intramuscular injection of extended release of placebo

Also known as: Placebo
Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent form;
  • Undergoing breast cancer surgery with axillary lymph node dissection during the current clinical trial;
  • Negative serum pregnancy test for women of childbearing potential;
  • Aspartate aminotransferase and alanine aminotransferase \< 2 x the upper limit of normal;
  • ECOG PS ≤ 1.

You may not qualify if:

  • Previous radiotherapy within five years from study drug administration on the same armpit undergoing surgery in this study;
  • Concomitant participation to other clinical trial;
  • Uncontrolled diabetes;
  • Cholelithiasis;
  • Human immunodeficiency virus or hepatitis B or C by screening serology;
  • 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;
  • Pregnant or lactating;
  • Ascertained or presumptive hypersensitivity to the active principle and/or the ingredients of the study drug formulation;
  • 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;
  • Clinically significant or relevant abnormal medical history, vital sign, physical examination or laboratory evaluation finding;
  • Corticosteroid treatment on a long-term basis (i.e. treatment for more than 3 consecutive days);
  • Current or recurrent disease that could affect the results of the clinical or laboratory assessment required for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Az. Osp. Univ. Mater Domini

Catanzaro, Calabria, 88100, Italy

Location

IRCCS Fondazione Pascale

Naples, Campania, 80131, Italy

Location

Az. Osp. Univ. di Ferrara - Ospedale di Cona

Ferrara, Emilia-Romagna, 44124, Italy

Location

Az.Osp. Univ. Policlinico di Modena

Modena, Emilia-Romagna, 41124, Italy

Location

Az. Osp. Univ. di Parma

Parma, Emilia-Romagna, 43126, Italy

Location

IRCCS Azienda Ospedaliera Universitaria San Martino

Genoa, Liguria, 16132, Italy

Location

Az. Osp. Univ. Città Della Salute e Della Scienza di Torino

Turin, Piedmont, 10126, Italy

Location

MeSH Terms

Conditions

Seroma

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Paolo Carcoforo, Prof.

    U.O. Clinica Chirurgica, A. O. Univ. Arcispedale S.Anna - Ferrara

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2016

First Posted

January 29, 2016

Study Start

October 22, 2015

Primary Completion

July 19, 2016

Study Completion

July 19, 2016

Last Updated

February 2, 2017

Record last verified: 2017-02

Locations

IT(7)