Clinical Trials Register

Summary
EudraCT Number:	2014-005289-31
Sponsor's Protocol Code Number:	LF-PB/14/05
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-01-21
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2014-005289-31

A.3

Full title of the trial

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

Studio multicentrico, randomizzato in doppio cieco, controllato verso placebo, per valutare l’efficacia di LF-PB sulla formazione di seroma dopo svuotamento ascellare in pazienti affette da cancro alla mammella.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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

Studio volto a valutare l’efficacia di LF-PB (30 mg) sulla incidenza e la durata di seroma dopo svuotamento ascellare in pazienti affette da cancro alla mammella

A.3.2

Name or abbreviated title of the trial where available

Seroma after axillary Lymph Node Dissection

Seroma dopo dissezione dei linfonodi ascellari

A.4.1

Sponsor's protocol code number

LF-PB/14/05

A.5.4

Other Identifiers

Name:

Number:

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	CHEMI S.P.A.
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Chemi S.p.A
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Italfarmaco S.p.A
B.5.2	Functional name of contact point	Clinical Research and Development
B.5.3	Address:
B.5.3.1	Street Address	Via dei Lavoratori, 54
B.5.3.2	Town/ city	Cinisello Balsamo (MI)
B.5.3.3	Post code	20092
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39 02 6443 2520
B.5.5	Fax number	+39 02 6443 3554
B.5.6	E-mail	p.bettica@italfarmaco.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	LF-PB
D.3.2	Product code	LF-PB
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	OCTREOTIDE ACETATO
D.3.9.1	CAS number	079517-01-4
D.3.9.2	Current sponsor code	LF-PB
D.3.9.3	Other descriptive name	OCTREOTIDE ACETATO
D.3.9.4	EV Substance Code	SUB09417MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Powder and solvent for solution for injection

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Woman with Breast Cancer Undergoing Axillary Lymph Node Dissection

Pazienti con cancro alla mammella sottoposte a dissezione linfonodale ascellare

E.1.1.1

Medical condition in easily understood language

Woman with Breast Cancer Undergoing Axillary Lymph Node Remove

Pazienti con cancro alla mammella sottoposte a svuotamento linfonodale ascellare

E.1.1.2

Therapeutic area

Diseases [C] - Blood and lymphatic diseases [C15]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	SOC
E.1.2	Classification code	10005329
E.1.2	Term	Blood and lymphatic system disorders
E.1.2	System Organ Class	10005329 - Blood and lymphatic system disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

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.

Valutare l’azione di LF-PB 30 mg rispetto al placebo sull’incidenza del seroma
Valutare la sicurezza e la tollerabilità di LF-PB 30 mg

E.2.2

Secondary objectives of the trial

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.

Valutare l’azione di LF-PB 30 mg rispetto al placebo sulla durata del seroma, il numero di aspirazioni e la quantità di fluido aspirate dal seroma
Valutare il profilo di farmacocinetica di LF-PB 30mg

To assess the pharmacokinetic profile of LF-PB 30mg.

E.2.3

Trial contains a sub-study

E.3

Principal 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.

1. Firma del Consenso Informato
2. Donne di almeno 18 anni compiuti
3. Pazienti che andranno incontro a un intervento di dissezione dei linfonodi ascellari nel corso di questo studio clinico
4. Test di gravidanza negativo per le donne in età fertile
5. Aspartato aminotransferasi e alanine amino transferasi < 2x limite superiore di normalità
6. ECOG PS ≤ 1
7. Deve rispettare i requisiti del protocollo.

E.4

Principal 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.

1. Precedente chirurgia ascellare sulla stessa ascella (la chirurgia per linfonodo sentinella non è un criterio di esclusione)
2. Radioterapia nei cinque anni precedenti la somministrazione del farmaco in studio sullo stessa ascella sottoposta ad intervento in questo studio
3. Partecipazione concomitante ad altri studi clinici
4. Diabete non controllato
5. Colelitiasi
6. Positività al virus HIV o all’epatite B o C rilevata ai test di screening sierologici
7. Ipotiroidismo non controllato: se la paziente riceve Eutirox / Levotiroxina (o analoghi) e i livelli di T3, T4 e TSH sono controllati e all’interno dei valori normali allo screening, la paziente può essere arruolata in questo studio
8. Pazienti gestanti o in fase di allattamento
9. Dimostrata o presunta ipersensibilità al principio attivo e/o agli ingredienti contenuti nella formulazione del farmaco in studio
10. Valore QT corretto (secondo la formula di Bazett, QTc) allo screening > 450 msec (calcolato come la media di 3 letture consecutive effettuate a 5 minuti di distanza). Presenza di malattia o utilizzo di farmaci concomitanti noti per aumentare l'intervallo QT
11. Storia medica clinicamente significativa o rilevante, segni vitali, esame fisico o valutazione degli esami di laboratorio anomali
12. Trattamento con corticosteroidi a lungo termine. L’utilizzo in acuto di corticosteroidi per prevenire reazioni d’ipersensibilità prima dell'intervento chirurgico non è da considerarsi un criterio d’esclusione
13. Malattia in corso o ricorrenti che potrebbero influenzare i risultati della valutazione clinica e i risultati degli esami di laboratorio necessari per lo studio

E.5 End points

E.5.1

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.

L'endpoint primario di questo studio è valutare l'incidenza di seromi che richiedono un'aspirazione entro il giorno 28. In fase d’intervento chirurgico sarà posto un drenaggio ascellare che sarà rimosso dopo circa 24 ore. Ogni paziente sarà sottoposta a un’ecografia al cavo ascellare operato a partire dalla Visita 2 (giorno 3) e ad ogni visita programmata fino alla Visita 7 (Giorno 28) o fino a risoluzione del seroma. Dopo la visita 7 (Giorno 28) l’ecografia sarà eseguita solo se clinicamente indicato. In caso di presenza di un seroma lo sperimentatore deciderà se sarà necessaria un’aspirazione del liquido; la decisione si baserà sulla valutazione clinica dello sperimentatore (ad esempio se causa disagio alla paziente).
In caso di aspirazione, il soggetto con seroma sarà considerato per l'analisi statistica d’incidenza dei seromi.
La sicurezza e la tollerabilità del trattamento saranno analizzati sulla base del numero di eventi avversi riportati, sulle anomalie dei dati di laboratorio, degli ECG e dei segni vitali.

E.5.1.1

Timepoint(s) of evaluation of this end point

28 days

28 giorni

E.5.2

Secondary end point(s)

PK parameters (at least Cmax, Tmax, AUC0-X and t1/2)

Parametri farmacocinetici (almeno Cmax, Tmax, AUC0-X e t1/2)

E.5.2.1

Timepoint(s) of evaluation of this end point

after 30 mg LF-PB single-dose administration.

dopo la somministrazione in una sola dose di LF-PB 30 mg.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Double Dummy

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

Information not present in EudraCT

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

Yes

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

According to clinical practice

In accordo alla pratica clinica

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2015-08-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-07-23

P. End of Trial
P.	End of Trial Status	Completed

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials