Clinical Trials Register

Summary
EudraCT Number:	2007-001105-13
Sponsor's Protocol Code Number:	WO20697
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:	2007-08-06
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

2007-001105-13

A.3

Full title of the trial

Estudio de fase II multicéntrico, internacional, randomizado de trastuzumab y docetaxel frente a trastuzumab, docetaxel y pertuzumab, comparado con trastuzumab y pertuzumab en pacientes con cáncer de mama localmente avanzado, inflamatorio o precoz HER2 positivo.

A randomised, multicenter, multinational Phase II study on trastuzumab plus docetaxel versus trastuzumab plus docetaxel plus pertuzumab versus trastuzumab plus pertuzumab in patients with locally advanced, inflammatory or early stage HER2 positive breast cancer.

A.4.1

Sponsor's protocol code number

WO20697

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	Pertuzumab (rhuMAb 2C4)
D.3.2	Product code	RO4368451
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	Pertuzumab
D.3.9.2	Current sponsor code	RO4368451
D.3.9.3	Other descriptive name	rhuMAb 2C4
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	175 mg/7 ml
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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	Yes
D.3.11.13.1	Other medicinal product type	Humanized monoclonal antibody
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	Yes
D.2.1.1.1	Trade name	Herceptin®
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited, UK
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.3.1	Product name	Herceptin
D.3.2	Product code	Ro 45-2317
D.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	Ro 45-2317
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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	Yes
D.3.11.13.1	Other medicinal product type	Humanized monoclonal antibody

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 localmente avanzado, inflamatorio o precoz HER2 positivo.

Locally advanced, inflammatory or early stage HER2 positive breast cancer.

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10065430
E.1.2	Term	HER-2 positive breast cancer

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10006200
E.1.2	Term	Breast cancer stage II

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10006201
E.1.2	Term	Breast cancer stage III

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10021974
E.1.2	Term	Inflammatory breast cancer

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Realizar una evaluación preliminar de la eficacia del tratamiento neoadyuvante con trastuzumab y docetaxel comparado con trastuzumab, pertuzumab y docetaxel, frente a trastuzumab y pertuzumab, en pacientes con cáncer de mama T2-4d HER2 positivo, basándose en el índice de respuesta completa patológica.

E.2.2

Secondary objectives of the trial

- Evaluar los perfiles de seguridad de cada régimen de tratamiento, incluyendo el tratamiento preoperatorio (neoadyuvante) y postoperatorio (adyuvante).
- Determinar el tiempo hasta la respuesta clínica, el tiempo hasta la respuesta, la supervivencia libre de enfermedad y la supervivencia libre de progresión en cada grupo de tratamiento.
- Evaluar los biomarcadores que pueden estar asociados con las variables de eficacia principal y secundarias, de acuerdo con cada grupo de tratamiento.
- Evaluar el índice de cirugía conservadora de la mama en todas las pacientes con tumores T2-3 en las que estaba previsto realizar mastectomía en el momento del diagnóstico.

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

Proyecto de Investigación (Protocolo WO20697RG) para el Banco de Muestras de Roche, asociado al Protocolo WO20697. Version A del 19 de junio de 2007.

Objetivo: Obtener una sola muestra de sangre en los pacientes que otorguen su consentimiento para ello, que ya están en el ensayo WO20697 asociado, para los análisis de investigación farmacogenética y genética.

E.3

Principal inclusion criteria

1. Mujeres ≥18 años con cáncer de mama localmente avanzado, inflamatorio o precoz, unilateral e invasivo confirmado histológicamente .
2. Tumor primario >2 cm de diámetro.
3. Tumor HER2 positivo, confirmado por un laboratorio central. Los tumores deben ser HER2+++ en IHC o FISH/CISH + (es obligatorio realizar FISH/CISH en los tumores HER2 ++).
4. Disponibilidad de tejido FFPE para la confirmación del estado de HER2 en el laboratorio central (el tejido tumoral FFPE se utilizará posteriormente para evaluar el estado de los biomarcadores).
5. Edad 18 años.
6. FEVI basal 55% (valorada en ecocardiograma o MUGA).
7. Estado funcional 1 de acuerdo con la escala ECOG.
8. Si la paciente ha sido sometida a una intervención de cirugía mayor no relacionada con el estudio, deben haber transcurrido como mínimo 4 semanas y se debe haber recuperado por completo.
9. Se debe realizar una prueba de embarazo en las mujeres premenopáusicas y en las que sean menopáusicas desde hace menos de 2 años y el resultado debe ser negativo.
10. Consentimiento informado firmado

E.4

Principal exclusion criteria

1. Enfermedad metastática (estadio IV)o cáncer de mama bilateral.
2. Administración previa de tratamiento anticanceroso o radioterapia para cualquier enfermedad neoplásica.
3. Otras neoplasias, a excepción de carcinoma in situ de cervix o carcinoma basocelular.
4. Función de médula ósea inadecuada (p. ej. recuento absoluto de neutrófilos [RAN] < 1,5 x 109/l, recuento de plaquetas < 100 x 109/l y Hb < 9 g/dl).
5. Función hepática alterada: (p. ej. bilirrubina sérica [total] > 1,25 x LSN (excepto en el caso de síndrome de Gilbert), AST, ALT > 1,25 x LSN, albúmina < 25 g/l
6. Función renal inadecuada, creatinina sérica >1,5 x LSN.
7. Hipertensión no controlada (sistólica 150 y/o diastólica 100), angina de pecho inestable, ICC de cualquier grado de acuerdo con la clasificación de la NYHA, arrtimias cardíacas graves que precisen tratamiento (a excepción de fibrilación auricular, taquicardia supraventricular paroxística), antecedentes de infarto de miocardio en los 6 meses previos a la inclusión en el estudio o FEVI < 55%.
8. Disnea en reposo, patologías que precisen oxigenoterapia continua.
9. Enfermedad sistémica no controlada severa (p. ej. hipertensión, trastornos cardiovasculares, pulmonares, metabólicos, así como heridas, úlceras o fracturas óseas, que sean clínicamente significativos).
10. Mujeres embarazadas o en período de lactancia.
11. Mujeres potencialmente fértiles que no estén dispuestas a utilizar métodos anticonceptivos eficaces.
12. Administración de cualquier tratamiento en investigación en las 4 semanas previas al inicio del estudio.
13. Pacientes con infección por VIH, VHB, VHC confirmada.
14. Hipersensibilidad confirmada a cualquiera de los fármacos del estudio o sus excipientes.
15. Pacientes que, de acuerdo con la opinión del investigador, no sean capaces o no estén dispuestas a cumplir los requisitos del protocolo.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is post-surgery pathological complete response rate in the breast (pCR) evaluated after 4 cycles of treatment and surgery or withdrawn from the study whichever occurs sooner. A pathological complete response is defined at the time of surgery and the rate is the proportion of the intent-to-treat population that achieve a pCR.

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

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Evaluation of biomarkers for response prediction

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

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

Yes

E.8.1.6

Cross over

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.8.3

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

Information not present in EudraCT

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

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

The end of study will be five years after randomization of the last patient or progressive disease experienced in all patients, whichever is earlier.

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

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.1.3

Elderly (>=65 years)

Yes

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Information not present in EudraCT

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

F.4.2.2

In the whole clinical trial

180

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)

After completion of the study no further provisional care is planned and all patients will be managed as per local standard practice.

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

2007-09-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-09-20

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-09-22

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