Clinical Trials Register

Summary
EudraCT Number:	2018-004593-98
Sponsor's Protocol Code Number:	ACT16105
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2019-11-11
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

2018-004593-98

A.3

Full title of the trial

An Open Label Randomized Phase 2 Trial of SAR439859, Versus Endocrine Monotherapy as per Physician’s Choice in Premenopausal and Postmenopausal Patients with Estrogen Receptor-positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer with Prior Exposure to Hormonal Therapies

Estudio Fase II, aleatorizado, abierto de SAR439859 versus monoterapia endocrina a elección médica en pacientes premenopáusicas y postmenopáusicas con cáncer de mama con receptores de estrógeno positivos, HER2 negativo localmente avanzado o metastásico con exposición previa a terapias hormonales

A.3.1

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

Phase 2 Study of SAR439859 versus Physician’s Choice in Premenopausal and Postmenopausal Locally Advanced or Metastatic ER-positive Breast Cancer

Estudio Fase II de SAR439859 en comparación con la elección médica en mujeres premenopáusicas y posmenopáusicas con cáncer de mama localmente avanzado o metastásico positivo para RE

A.4.1

Sponsor's protocol code number

ACT16105

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1217-2774

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	SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
B.1.3.4	Country	France
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	SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	sanofi-aventis, s.a.
B.5.2	Functional name of contact point	Unidad de Estudios Clínicos
B.5.3	Address:
B.5.3.1	Street Address	c/ Josep Pla 2, 4ª planta
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08019
B.5.3.4	Country	Spain
B.5.4	Telephone number	93 485 94 00
B.5.6	E-mail	es-unidadestudiosclinicos@sanofi.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.3.2	Product code	SAR439859
D.3.4	Pharmaceutical form	Capsule, hard
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	NA
D.3.9.2	Current sponsor code	SAR439859
D.3.9.4	EV Substance Code	SUB186740
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	100
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	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	Faslodex®
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca AB
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	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FULVESTRANT
D.3.9.3	Other descriptive name	FULVESTRANT
D.3.9.4	EV Substance Code	SUB13933MIG
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	250
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	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	In accordance with the approved label
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
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	ANASTROZOLE
D.3.9.3	Other descriptive name	ANASTROZOLE
D.3.9.4	EV Substance Code	SUB05502MIG
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	1
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	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	In accordance with the approved label
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
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	LETROZOLE
D.3.9.1	CAS number	112809-51-5
D.3.9.3	Other descriptive name	LETROZOLE
D.3.9.4	EV Substance Code	SUB08444MIG
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	2.5
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: 5
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	In accordance with the approved label
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
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	EXEMESTANE
D.3.9.3	Other descriptive name	EXEMESTANE
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: 6
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	In accordance with the approved label
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
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	TAMOXIFEN
D.3.9.1	CAS number	10540-29-1
D.3.9.3	Other descriptive name	TAMOXIFEN
D.3.9.4	EV Substance Code	SUB10825MIG
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	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	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

Cancer

Cáncer

E.1.1.1

Medical condition in easily understood language

Cancer

Cáncer

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	20.1
E.1.2	Level	PT
E.1.2	Classification code	10055113
E.1.2	Term	Breast cancer metastatic
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

To determine whether SAR439859 per os improves progression free survival (PFS) when compared with a endocrine monotherapy of the choice of the physician, in participants with metastatic or locally advanced breast cancer.

Determinar si SAR439859 por vía oral mejora la supervivencia libre de progresión (SLP) en comparación con una monoterapia endocrina a elección del médico, en participantes con cáncer de mama metastásico o localmente avanzado.

E.2.2

Secondary objectives of the trial

- To compare the objective response rate in the 2 treatment arms.
- To evaluate the disease control rate in the 2 treatment arms.
- To evaluate the clinical benefit rate in the 2 treatment arms.
- To evaluate the duration of response in the 2 treatment arms.
- To evaluate the PFS according to the estrogen receptor 1 gene (ESR1) mutation status in the 2 treatment arms.
- To evaluate the overall survival in the 2 treatment arms.
- To evaluate the pharmacokinetics of SAR439859 as single agent.
- To evaluate health related quality of life in the 2 treatment arms.
- To evaluate the overall safety profile in the 2 treatment arms.

- Comparar la tasa de respuesta objetiva en los 2 grupos de tratamiento.
- Evaluar la tasa de control de la enfermedad en los 2 grupos de tratamiento.
- Evaluar la tasa de beneficio clínico en los 2 grupos de tratamiento.
- Evaluar la duración de la respuesta en los 2 grupos de tratamiento.
- Evaluar la SLP según el estado de mutación del gen del receptor de estrógeno 1 (ESR1) en los 2 grupos de tratamiento.
- Evaluar la supervivencia global en los 2 grupos de tratamiento.
- Evaluar la farmacocinética de SAR439859 en monoterapia.
- Evaluar la calidad de vida relacionada con la salud en los 2 grupos de tratamiento.
- Evaluar el perfil de supervivencia global en los 2 grupos de tratamiento.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- 18 years or older
- Histological or cytological diagnosis of adenocarcinoma of the breast.
- Locally advanced not amenable to radiation therapy or surgery in a curative intent, and/or metastatic disease.
- ER positive status
- HER2 negative status
-For patients with tumor accessible for paired biopsy at study entry: baseline samples, formalin fixed paraffin embedded (FFPE) archived biopsy samples (within 3 months prior initiation of study treatment) can be used, but preferably fresh biopsies from primary tumor or recurrence or metastasis, will be collected.
- Participants must have received no more than 1 prior chemotherapeutic or 1 targeted therapy regimen for advanced/metastatic disease.
Participants must have progressed after at least 6 months of a continuous prior endocrine therapy for advanced breast cancer
- Participants must be postmenopausal women,

- La participante debe tener de 18 años (inclusive) mayor de 18 años.
- Participantes con diagnóstico demostrado histológico o citológico de adenocarcinoma de mama.
- Participantes con evidencia de enfermedad localmente avanzada no susceptible a radioterapia o cirugía con intención curativa, y/o metástasis.
- Documentación de RE positivo
- El tumor primario o cualquiera de las localizaciones metastásicas deben mostrar HER2 sin sobreexpresión según IHQ
- En las participantes con tumor accesible para biopsias pareadas a la entrada en el estudio se podrán usar muestras basales de biopsia de archivo fijadas en formol e incluidas en parafina (FFIP) (dentro de los 3 meses anteriores al inicio del tratamiento del estudio), pero se obtendrán preferentemente biopsias recientes del tumor primario, de la recidiva o de la metástasis. Se recomienda que la segunda biopsia se recoja del mismo lugar que la biopsia basal, siempre que sea posible.
- Se permiten la quimioterapia previa (incluidos los conjugados anticuerpo-fármaco) o los tratamientos selectivos: las participantes no deben haber recibido más de 1 pauta previa de quimioterapia o 1 de tratamiento selectivo para la enfermedad avanzada/metastásica.
- Las participantes deben haber mostrado progresión después de al menos 6 meses de un tratamiento endocrino continuo previo para el cáncer de mama avanzado
- Las participantes deben ser mujeres posmenopáusicas

E.4

Principal exclusion criteria

- Eastern Cooperative Oncology Group performance status ≥2.
- Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of SAR439859. Participants unable to swallow normally and to take capsules.
- Participant with any other cancer. Adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or any other cancer from which the participant has been disease free for >3 years are allowed.
- Severe uncontrolled systemic disease at screeening
- Participants with bone-only metastasis .
- Participants with known brain metastases that are untreated, symptomatic or require therapy to control symptoms.
- Prior treatment with mammalian target of rapamycin inhibitors or any other selective estrogen receptor degrader (SERD) compound, except fulvestrant if stopped for at least3 months before randomization.
- Treatment with antiviral agents, antifungal, and antioxidant agents less than 2 weeks before randomization .
- Treatment with strong or moderate CYP3A inducers within 2 weeks before randomization.
- Ongoing treatment with drugs that are substrate of P-glycoprotein (P gp) (dabigatran, digoxin, fexofenadine).
- Treatment with anticancer agents (including investigational drugs) less than 3 weeks before randomization.
- Inadequate hematological, coagulation, renall and liver functions.

- Estado funcional según el Grupo Oncológico Cooperativo de la Costa Este superior o igual a 2
- Antecedentes médicos o trastornos gastrointestinales en curso que puedan afectar a la absorción del SAR439859 por vía oral. Participantes incapaces de tragar normalmente y de tomar cápsulas.
- Participantes con cualquier otro cáncer. Se admiten las participantes con carcinoma basocelular o epidermoide tratado adecuadamente, cáncer cervical in situ o cualquier otro cáncer para el que la participante haya estado libre de enfermedad durante >3 años.
- Enfermedad sistémica grave no controlada en la selección
- Participantes con metástasis solo óseas.
- Participantes con metástasis cerebrales conocidas que no reciben tratamiento, son sintomáticas o requieren terapia para controlar los síntomas.
- Tratamiento previo con inhibidores de la diana de rapamicina en mamíferos o cualquier otro compuesto DSRE, excepto fulvestrant si se interrumpe durante al menos 3 meses antes de la aleatorización.
- Tratamiento con antivíricos, antifúngico y antioxidante menos de 2 semanas antes de la aleatorización
- Tratamiento con inductores potentes o moderados del citocromo P450 (CYP) dentro de las 2 semanas anteriores a la aleatorización
- Tratamiento en curso con fármacos que sean sustratos de la glucoproteína P (P-gp) (dabigatrán, digoxina, fexofenadina)
- Tratamiento con antineoplásicos (incluidos los fármacos en investigación) menos de 3 semanas antes de la aleatorización.
- Funcionalidad hematológica, coagulación, renal o hepática insuficiente

E.5 End points

E.5.1

Primary end point(s)

Progression free survival (PFS)

supervivencia libre de progresión (SLP)

E.5.1.1

Timepoint(s) of evaluation of this end point

Up to 17 months after the first randomized participant

Hasta 17 meses después del primer participante aleatorizado

E.5.2

Secondary end point(s)

1- Objective Response Rate (ORR)
2 - Disease Control Rate (DCR)
3 - Clinical Benefit Rate (CBR)
4 - Duration of Response (DOR)
5 - PFS according to (ESR1) mutation status
6 - Overall Survival (OS)
7 - Assessments of the Pharmacokinetic (PK) parameter of SAR439859: Plasma Concentrations
8 - Patient Reported Outcome (PRO) - health-related quality of life and health status using the European Quality of Life-5 Dimensions (EQ-5D)
9 - Patient Reported Outcome (PRO) - the European Organisation for Research and Treatment of Cancer core quality of life questionnaire (EORTC-QLQ-C30)
10 - Patient Reported Outcome (PRO) - EORTC-QLQ breast cancer (EORTC-QLQ-BR23)
11 - Overall safety profile

1- tasa de respuesta objetiva
2 - tasa de control de la enfermedad
3 - tasa de beneficio clínico
4 - duración de la respuesta
5 - Supervivencia libre de progresión según el estado de ESR1
6 - supervivencia global
7 - Concentraciones plasmáticas de SAR439859
8 - Calidad de vida relacionada con la salud general y específica de la enfermedad informada por el paciente utilizando el European Quality of Life-5 Dimensions (EQ-5D)
9 - Los síntomas relacionados con el tratamiento y con la enfermedad informados por el paciente utilizando el European Organisation for Research and Treatment of Cancer core quality of life questionnaire (EORTC-QLQ-C30)
10 - La utilidad del estado de salud y el estado de salud informado por el paceinte utilizando la EORTC-QLQ breast cancer (EORTC-QLQ-BR23)
11 – Perfil de seguridad global

E.5.2.1

Timepoint(s) of evaluation of this end point

1-5 - Up to 17 months after the first randomized participant
6 - Up to 35 months after the first randomized participan
7- Day 1 and Day 15 of Cycle 1 and Day 1 of subsequent cycle every 2 cycles up to to 30 days after last study treatment (each cycle is 28 days)
8 to 10 - Day 1 of Cycle 1 and day 1 of subsequent cycle every 2 cycles up to to 30 days after last study treatment (each cycle is 28 days)
11 - Evaluated continuously throughout study, up to 30 days after last study treatment administration

1-5 - Hasta 17 meses después del primer participante aleatorizado
6 - Hasta 35 meses después de la primera participación aleatoria
7- Día 1 y Día 15 del Ciclo 1 y Día 1 del ciclo posterior cada 2 ciclos hasta 30 días después del último tratamiento del estudio (cada ciclo es de 28 días)
8 a 10 - Día 1 del ciclo 1 y día 1 del ciclo posterior cada 2 ciclos hasta 30 días después del último tratamiento del estudio (cada ciclo es de 28 días)
11 - Evaluado continuamente durante todo el estudio, hasta 30 días después de la última administración del tratamiento del estudio

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

Yes

E.6.7

Pharmacodynamic

Yes

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

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)

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

Argentina

Australia

Belgium

Brazil

Canada

Czech Republic

France

Greece

Israel

Italy

Korea, Republic of

Mexico

Poland

Russian Federation

Spain

Sweden

Taiwan

Turkey

Ukraine

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

LVLS

Última visita del último paciente (LPLV)

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:

155

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

127

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

282

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)

None

Ninguno

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

2019-12-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-12-18

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2022-08-16

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