Clinical Trials Register

Summary
EudraCT Number:	2010-024099-25
Sponsor's Protocol Code Number:	MO22982
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-07-29
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2010-024099-25

A.3

Full title of the trial

A randomized, multi-center cross-over study to evaluate patient preference and Health Care Professional (HCP) satisfaction with subcutaneous (SC) administration of trastuzumab in HER2-positive early breast cancer (EBC)

Estudio multicéntrico, randomizado, cruzado, para evaluar la preferencia de las pacientes y la satisfacción de los profesionales sanitarios (PS) con la administración subcutánea (SC) de trastuzumab en cáncer de mama precoz (CMP) HER2-positivo.

A.3.1

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

A study to evaluate both patients' preference and doctors' and nurses' satisfaction with subcutaneous administration(under the skin) of trastuzumab in patients with breast cancer.

Estudio para evaluar la preferencia y satisfacción de pacientes, médicos y enfermeras con la administración subcutanea (balo la piel) de trastuzuman en pacientes con cáncer de mama

A.3.2

Name or abbreviated title of the trial where available

PrefHer Study

A.4.1

Sponsor's protocol code number

MO22982

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT00000000

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	F. Hoffmann-La Roche Ltd
B.1.3.4	Country	Switzerland
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	F. Hoffmann-La Roche Ltd
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	F. Hoffmann-La Roche Ltd
B.5.2	Functional name of contact point	Trial Information Support Line-TISL
B.5.3	Address:
B.5.3.1	Street Address	Grenzacherstrasse 12
B.5.3.2	Town/ city	Basel
B.5.3.3	Post code	4050
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	+41616881111NA
B.5.5	Fax number	+41616919319NA
B.5.6	E-mail	global.rochegenentechtrials@roche.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	Herceptin SC
D.3.2	Product code	Ro 045-2317/F06
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Trastuzumab SC
D.3.9.1	CAS number	180288-69-1
D.3.9.2	Current sponsor code	RO0452317
D.3.9.3	Other descriptive name	rhuMAb HER2, Anti-HER
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	120
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Yes
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	Yes
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.IMP: 2
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	Herceptin SC
D.3.2	Product code	Ro 045-2317/F04
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Trastuzumab sc
D.3.9.1	CAS number	180288-69-1
D.3.9.2	Current sponsor code	RO0452317
D.3.9.3	Other descriptive name	rhuMAb HER2, Anti-HER
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	120
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	Yes
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.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
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	Yes
D.2.1.1.1	Trade name	Herceptin®
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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.3.4	Pharmaceutical form	Powder for concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TRASTUZUMAB
D.3.9.1	CAS number	180288-69-1
D.3.9.2	Current sponsor code	RO0452317
D.3.9.3	Other descriptive name	rhuMAb HER2, Anti-HER
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	Yes
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Cáncer de mama precoz HER2 positivo

E.1.1.1

Medical condition in easily understood language

Cáncer de mama

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	LLT
E.1.2	Classification code	10065430
E.1.2	Term	HER-2 positive breast cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluar la proporción de pacientes que indican una preferencia global por la vía de administración subcutánea (SC) o intravenosa (IV).

E.2.2

Secondary objectives of the trial

- Satisfacción de los profesionales sanitarios con trastuzumab SC
- Ahorro de tiempo percibido por los profesionales sanitarios con trastuzumab SC
Seguridad y tolerancia
- Eficacia – supervivencia libre de acontecimientos (SLA)
- Inmunogenicidad de trastuzumab e hialuronidasa recombinante humana (rHuPH20)

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Estudio de tiempo y movimiento de las formulaciones subcutánea (SC) e intravenosa (IV) de trastuzumab para el tratamiento de pacientes con cáncer de mama precoz (CMP) positivo para HER2. 28 de junio de 2011 Versión 5.0.
Objetivos principales:
-Cuantificar la utilización de recursos en cuanto al tiempo “activo” de los PS y en cuanto a los consumibles así como sus costes asociados relacionados con la inyección SC de trastuzumab (con dispositivo de inyección de un solo uso [DIS]) y la infusión IV de trastuzumab en el tratamiento de pacientes con CMP positivo para HER2 en el contexto del ensayo clínico PrefHer.
-Calcular el tiempo medio y los costes de los procesos SC e IV por paciente y por centro así como el ahorro potencial estimado de tiempo y costes por centro y por país (agrupando los datos de todos los centros de un país) derivado del cambio de la vía de administración IV a SC.
Objetivo secundario:
-Calcular el tiempo que permanece la paciente en la unidad asistencial y el tiempo en sillón para trastuzumab SC y trastuzumab IV por país.
Más detalles en protocolo independiente.

E.3

Principal inclusion criteria

1.Mujeres de ≥ 18 años
2.Cáncer de mama HER2 positivo
3.Las pacientes no deben presentar indicios de enfermedad residual, localmente recurrente o metastásica tras completar el tratamiento con cirugía y quimioterapia (en el entorno neoadyuvante o adyuvante).
4.Las pacientes deben haber completado todo el tratamiento con quimioterapia (neo)adyuvante, pero podrán ser incluidas en el estudio mientras estén recibiendo radioterapia adyuvante.
5.Las pacientes pueden haber recibido previamente trastuzumab IV, sin embargo, la paciente debe estar pendiente de recibir, como mínimo, 10 de los 18 ciclos planeados de tratamiento con trastuzumab administrado cada 3 semanas.
6.Estado funcional ECOG 0 o 1

E.4

Principal exclusion criteria

1.Antecedentes de otras neoplasias que podrían afectar al cumplimiento con el protocolo o la interpretación de los resultados. Las pacientes con carcinoma in situ de cervix o carcinoma basocelular tratados de forma curativa y las pacientes con otras neoplasias tratadas de forma curativa que hayan estado libres de enfermedad durante al menos 5 años, son aptas para participar en el estudio. Las pacientes con antecedentes de carcinoma ductal in situ (CDIS) de la mama también son aptas para participar en el estudio.
2.Función de médula ósea inadecuada:
3.Alteraciones de la función hepática
4.Función renal inadecuada
5.enfermedades cardiacas o patologías vasculares graves
6.Infección confirmada por virus de inmunodeficiencia humana (VIH), hepatitis B activa (VHB) o hepatitis C (VHC)
7.Administración previa de una dosis acumulada máxima de doxorubicina >360 mg/m2 o de epirubicina >720 mg/m2 o equivalentes

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint will be assessed by the following question on the second patient interview (PINT2) : ?All things considered which method of administration did you prefer??

La variable principal se evaluará mediante la siguiente pregunta en la segunda entrevista con la paciente (PINT2): “Teniendo en cuenta todos los aspectos, ¿qué método de administración prefería usted?”.

E.5.1.1

Timepoint(s) of evaluation of this end point

Una vez que las pacientes hayan completado los 8 primeros ciclos del tratamiento del estudio, es decir, 4 ciclos de trastuzumab SC y 4 ciclos de trastuzumab i.v.

E.5.2

Secondary end point(s)

•Satisfacción de los profesionales sanitarios con trastuzumab SC
•Ahorro de tiempo percibido por los profesionales sanitarios con trastuzumab SC
•Seguridad
•Eficacia
•Inmunogenicidad de trastuzumab e hialuronidasa recombinante humana (rHuPH20)

E.5.2.1

Timepoint(s) of evaluation of this end point

Ver protocolo MO22982, sección 8.2.1.2 Variables secundarias

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

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

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

Yes

E.6.13.1

Other scope of the trial description

Immunogenicity; Patient preference; HCP Satisfaction

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

Yes

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

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

Yes

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Denmark

France

Germany

Italy

Poland

Russian Federation

Spain

Sweden

Switzerland

Turkey

United Kingdom

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

El estudio terminará con la última visita realizada por la última paciente (UVUP) en el período de seguimiento

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.1.1.1

In Utero

F.1.1.2

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

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

150

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

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

140

F.4.2.2

In the whole clinical trial

200

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)

Las pacientes que finalicen su participación en el estudio, serán tratadas con la práctica clínica local. Las pacientes que discontinúen el tratamiento serán evaluadas por el investigador. Si en el momento de la retirada del estudio de la paciente hay un acontecimiento adverso (AA), se debe realizar su seguimiento hasta que se observe la resolución o una estabilización, o hasta perdida de seguimiento de la paciente, o se determine que la causa no es la participación o tratamiento del estudio.

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

2011-09-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-09-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-05-23

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