Clinical Trials Register

Summary
EudraCT Number:	2012-003757-28
Sponsor's Protocol Code Number:	CRAD001Y2201
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:	2013-04-09
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

2012-003757-28

A.3

Full title of the trial

A three-arm, randomized, open label, phase II study of everolimus in combination with exemestane versus everolimus alone versus capecitabine in the treatment of postmenopausal women with estrogen receptor positive, locally advanced, recurrent, or metastatic breast cancer after recurrence or progression on prior letrozole or anastrozole

Estudio fase II, aleatorizado, abierto, con tres brazos, de everolimus en combinación con exemestano frente a everolimus en monoterapia frente a capecitabina, para el tratamiento de mujeres postmenopáusicas con cáncer de mama con receptor estrogénico positivo, localmente avanzado, recurrente o metastásico después de recurrencia o de progresión a letrozol o anastrozol previo

A.3.1

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

A study of everolimus plus exemestane versus everolimus versus capecitabine in postmenopausal women with ER+ ABC after recurrence or progression on non-steroidal aromatase inhibitor (NSAI)

Un estudio de everolimus más exemestano frente a everolimus frente a capecitabina en mujeres postmenopáusicas con cáncer de mama con receptor estrogénico positivo, localmente avanzado, recurrente o metastásico después de recurrencia o de progresión a letrozol o anastrozol previo

A.3.2

Name or abbreviated title of the trial where available

BOLERO-6

A.4.1

Sponsor's protocol code number

CRAD001Y2201

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	Novartis Farmacéutica S.A.
B.1.3.4	Country	Spain
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	Novartis Pharma Services AG
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	Novartis Farmacéutica S.A.
B.5.2	Functional name of contact point	Departamento Médico Oncología (GMO)
B.5.3	Address:
B.5.3.1	Street Address	Gran Via de les Corts Catalanes, 764
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08013
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34900353036
B.5.5	Fax number	+34932479903
B.5.6	E-mail	eecc.novartis@novartis.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	Yes
D.2.1.1.1	Trade name	Afinitor
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm 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.3.1	Product name	Everolimus
D.3.2	Product code	RAD001
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	everolimus
D.3.9.1	CAS number	159351-69-6
D.3.9.2	Current sponsor code	RAD001
D.3.9.3	Other descriptive name	EVEROLIMUS
D.3.9.4	EV Substance Code	SUB02065MIG
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	5
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	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	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.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	Afinitor
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm 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.3.1	Product name	Everolimus
D.3.2	Product code	RAD001
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	everolimus
D.3.9.1	CAS number	159351-69-6
D.3.9.2	Current sponsor code	RAD001
D.3.9.3	Other descriptive name	EVEROLIMUS
D.3.9.4	EV Substance Code	SUB02065MIG
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	10
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	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	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.IMP: 3
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.2.1.2	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	exemestano
D.3.4	Pharmaceutical form	Coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	exemestano
D.3.9.1	CAS number	107868-30-4
D.3.9.3	Other descriptive name	EXEMESTANO
D.3.9.4	EV Substance Code	SUB07492MIG
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	25
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	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	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.IMP: 4
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	XELODA
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.3.1	Product name	Xeloda
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	capecitabine
D.3.9.1	CAS number	154361-50-9
D.3.9.3	Other descriptive name	CAPECITABINE
D.3.9.4	EV Substance Code	SUB12474MIG
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	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	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	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.IMP: 5
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	XELODA
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.3.1	Product name	Xeloda
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	capecitabine
D.3.9.1	CAS number	154361-50-9
D.3.9.3	Other descriptive name	CAPECITABINE
D.3.9.4	EV Substance Code	SUB12474MIG
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	500
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	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	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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Estrogen receptor positive locally advanced or metastatic breast cancer in postmenopausal women

Mujeres postmenopaúsicas con cancer de mama metastásico o localmente
avanzado con receptor estrogénico positivo.

E.1.1.1

Medical condition in easily understood language

Estrogen receptor positive locally advanced or metastatic breast cancer in postmenopausal women

Mujeres postmenopaúsicas con cancer de mama metastásico o localmente
avanzado con receptor estrogénico positivo

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	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10070575
E.1.2	Term	Estrogen receptor positive breast cancer
E.1.2	System Organ Class	100000004864

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 estimate the hazard ratio of PFS for everolimus plus exemestane versus everolimus alone in postmenopausal women with ER positive, HER2 negative, advanced breast cancer after recurrence or progression on letrozole or anastrozole

Calcular la tasa de riesgo de la supervivencia libre de progresión para everolimus más exemestano frente a everolimus en monoterapia en mujeres postmenopáusicas con Cancer de Mama, ER+, HER2-, después de recurrencia o progresión a letrozol o anastrozol.

E.2.2

Secondary objectives of the trial

- To estimate the hazard ratio of PFS for everolimus plus exemestane versus capecitabine in postmenopausal women with ER positive, HER2 negative, advanced breast cancer after recurrence or progression on letrozole or anastrozole
- Overall survival
- Overall response rate
- Clinical benefit rate
- Safety
- Changes in ECOG performance status
- Change in quality of life scores over time
- Treatment satisfaction using Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4

Evaluar los grupos de tratamiento con respecto a:
- La supervivencia global
- La tasa de respuesta global
- La tasa de beneficio clínico
- La seguridad
- Los cambios en el estado funcional del ECOG
- Los cambios en las puntuaciones de la calidad de vida a lo largo del tiempo
- La satisfacción del tratamiento utilizando el cuestionario de satisfacción del tratamiento con la medicación (TSQM)
- Calcular la tasa de riesgo de la SLP para everolimus más exemestano frente a capecitabina en mujeres postmenopáusicas con cáncer de mama avanzado, ER positivo, HER2 negativo después de recurrencia o progresión a letrozol o anastrozol

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Women with locally advanced, recurrent, or metastatic breast cancer along with confirmation of estrogen-receptor positive (ER+).
- Measurable disease defined as at least one lesion ? 10 mm by CT or MRI that can be accurately measured in at least one dimension (CT scan slice thickness ? 5 mm) OR ? Bone lesions: lytic or mixed (lytic + blastic) in the absence of measurable disease as defined above.

Other protocol-defined inclusion criteria may apply

1.Mujeres con cáncer de mama localmente avanzado, recurrente o metastásico. El cáncer de mama localmente avanzado no es candidato a tratamiento curativo con cirugía o radioterapia.
2.Confirmación histológica o citológica de cáncer de mama ER+
3.Mujeres postmenopáusicas. El estado postmenopáusico se define con:
?Edad ? 18 con ooforectomía bilateral previa
?Edad ? 60 años
?Edad < 60 años con amenorrea durante por lo menos 12 meses y niveles tanto de la hormona folículo estimulante (FSH) como de estradiol dentro del rango postmenopáusico (según el laboratorio local).
Nota: la radiación de ovarios o el tratamiento con agonistas de la hormona liberadora de hormona luteinizante (LH-RH) (acetato de goserelina o acetato de leuprolida) no satisface este criterio de inclusión.
4.Recurrencia o progresión a AIs previos definido como:
?Recurrencia mientras, o durante el año (365 días) después del final del tratamiento adyuvante con un inhibidor de la aromatasa
?Progresión mientras, o durante el mes (30 días) después del final del tratamiento previo con un inhibidor de la aromatasa para el CMA
Notas:
?Letrozol o anastrozol no han de ser el ultimo tratamiento previo a la aleatorización
?Las pacientes deberán haberse recuperado a grado 1 o mejor de cualquier acontecimiento adverso (excepto alopecia) relacionado con la terapia previa antes de la aleatorización
5.Evidencia radiológica u objetiva de recurrencia o progresión con o después de la última terapia previa sistémica antes de la aleatorización
6.Las pacientes deberán presentar:
?Enfermedad medible definida como por lo menos una lesión ? 10 mm con TC o RM que pueda medirse con exactitud al menos en una dimensión (grosor de la sección de la TC ? 5 mm)
?Lesiones óseas: líticas o mixtas (líticas y blásticas) en ausencia de enfermedad medible definida anteriormente
Notas:
?Los ganglios linfáticos han de medir ? 15 mm en el eje más corto para ser considerados medibles
?Si las lesiones óseas han sido previamente irradiadas, por lo menos una lesión deberá haber progresado claramente desde la radioterapia con TC, RM o radiografía para entrar en el ensayo (en ausencia de enfermedad medible)

E.4

Principal exclusion criteria

-Patients who received more than one chemotherapy line.
-Patients with only non-measurable lesions other than lytic or mixed (lytic and blastic) bone metastasis.
- Previous treatment with exemestane, mTOR inhibitors, PI3K inhibitors or AKT inhibitors.

Other protocol-defined exclusion criteria may apply

1.Pacientes que sobreexpresen HER2 con análisis de laboratorio local (tinción IHC 3+ o hibridización in situ positiva), basado en el análisis más reciente. Nota: las pacientes con IHC 2+ deberán presentar una prueba de hibridización in situ negativa.
2.Pacientes que hayan recibido más de una línea de quimioterapia para el CMA
Nota: Una línea de quimioterapia en enfermedad avanzada es un régimen antineoplásico que contiene por lo menos 1 agente citotóxico quimioterapéutico y es administrado durante 21 días o más. Si un régimen citotóxico quimioterapéutico fue retirado por un motivo que no sea progresión de la enfermedad y que dure menos de 21 días, entonces este régimen no cuenta como una ?línea previa de quimioterapia?. Los regímenes de quimioterapia compuestos de más de un fármaco son considerados como una línea de terapia.
3.Pacientes sólo con lesiones no medibles que no sean metástasis óseas líticas o mixtas (líticas y blásticas) (por ejemplo, derrame pleural, ascitis, etc).
4.Pacientes que sean tratadas con fármacos que se conoce que son inhibidores o inductores potentes de la isoenzima CYP3A (Rifabutina, Rifampicina, Claritromicina, Ketoconazol, Itraconazol, Voriconazol, Ritonavir, Telitromicina) de forma continua durante por lo menos 7 días durante cualquier periodo de tiempo en las últimas 2 semanas antes de la aleatorización.
5.Pacientes que estén siendo tratadas con fármacos que se conoce que son inhibidores potentes o moderados de la isoenzima CYP2D6 (Fluoxetina, Paroxetina, Quinidina, Bupropion, Duloxetina, Difenhidramina, tioridazina, Amiodarona, Cimetidina, Sertralina) o inductores (Dexametasona, Rifampina) dentro de los últimos 5 días antes de la aleatorización.
6.Pacientes que sean tratadas con fármacos que se conoce que son inhibidores potentes o moderados de la isoenzima CYP2C9 (Fluconazol, Miconazol, Sulfafenazol, Amiodarona, Ácido valproico) o inductores (Secobarbital, Rifampina) dentro de los últimos cinco días antes de la aleatorización

E.5 End points

E.5.1

Primary end point(s)

Supervivencia libre de progresión (SLP) basada en la evaluación del tumor del investigador/radiólogo local (RECIST 1.1)

E.5.1.1

Timepoint(s) of evaluation of this end point

Estimated to occur 28 months after first patient randomized

28 meses después del primer paciente randomizado.

E.5.2

Secondary end point(s)

- To estimate the hazard ratio of PFS for everolimus plus exemestane versus capecitabine in postmenopausal women with ER positive, HER2 negative, advanced breast cancer after recurrence or progression on letrozole or anastrozole
- To evaluate the treatment groups with respect to Overall Survival
- Overall response rate (ORR) ) based on the local radiologist/investigator?s tumor assessment (RECIST 1.1)
- Clinical Benefit Rate
- Safety: Incidence of adverse events, serious adverse events, changes from baseline in vital signs and laboratory results (hematology, blood chemistry)
- Changes in ECOG performance status
- Change in quality of life scores over time

Supervivencia global
Tasa de respuesta global (TRG) basada en la evaluación del tumor del investigador/radiólogo local (RECIST 1.1)
Tasa de beneficio clínico (TBC)
Seguridad: incidencia de acontecimientos adversos, acontecimientos adversos graves, cambios en los resultados de laboratorio y en las constantes vitales (hematología, bioquímica)
Tiempo hasta el deterioro del estado funcional del ECOG
Tiempo hasta la puntuación del TSQM de deterioro de la calidad de vida (QoL)

E.5.2.1

Timepoint(s) of evaluation of this end point

- Estimated to occur 28 months after first patient randomized
- Every 3 months following last treatment date
- every 6 weeks to registered disease progression
- every 6 weeks to registered disease progression
- Every visit
- Time to ECOG performance deterioration
- EORTC (QLQ-C30)/EORTC module (BR23): Baseline, every 6 weeks and end of treatment visit. TSQM: Baseline, week 3,6, 12 and end of treatment.

-28 meses después del primer paciente randomizado.
-Cada 3 meses siguientes a la fecha del último tratamiento
-Cada 6 semanas hasta progresión de la enfermedad registrada
-Cada 6 semanas hasta progresión de la enfermedad registrada
-Cada visita
-Tiempo de deterioro del desempeño ECOG
-EORTC (QLQ-C30) / EORTC módulo (BR23): Línea de base, cada 6 semanas y al final de la visita de tratamiento. TSQM: Línea de base, la semana 3,6, 12 y al final del tratamiento

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

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

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

brazo de la combinación del brazo de everolimus y exemestano es considerado el brazo de control

combination arm of everolimus and exemestane is the considered control arm

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

Argentina

Australia

Belgium

Brazil

Denmark

Egypt

Hungary

India

Ireland

Lebanon

Malaysia

Peru

Saudi Arabia

Spain

Sweden

Thailand

Turkey

United Kingdom

United States

E.8.7

Trial has a data monitoring committee

Yes

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

LPLV (last patient last visit)

La definición de final del estudio será la fecha de la última visita de la última paciente

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

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:

240

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

F.3.3.1

Women of childbearing potential not using contraception

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

300

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)

Please refer to the protocol

Por favor consultar el Protocolo

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

2013-04-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-04-17

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-07-30

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Orphan Designation Number:
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