Clinical Trials Register

Summary
EudraCT Number:	2022-000095-18
Sponsor's Protocol Code Number:	21656
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-07-11
Trial 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

2022-000095-18

A.3

Full title of the trial

A double-blind, randomized, placebo-controlled multicenter study to investigate efficacy and safety of elinzanetant for the treatment of vasomotor symptoms caused by adjuvant endocrine therapy, over 52 weeks in women with, or at high risk for developing hormone-receptor positive breast cancer

Ensayo multicéntrico, randomizado, doble ciego, controlado con placebo para evaluar la eficacia y seguridad del Elinzanetant para el tratamiento de los síntomas vasomotores causados por la terapia endocrina adyuvante, durante 52 semanas, en mujeres con cáncer de mama positivo a receptores hormonales o alto riesgo de desarrollarlo.

A.3.1

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

A study to learn more about how well elinzanetant works and how safe it is compared to placebo for the treatment of hot flashes caused by anti-cancer therapy in women with, or at high risk for developing hormone-receptor positive breast cancer

Estudio para saber más acerca de cómo funciona y lo seguro que es Elinzanetant comparado con placebo para el tratamiento de los sofocos causados por la terapia anticancerígena en mujeres con cáncer de mama positivo a receptores hormonales o alto riesgo de desarrollarlo

A.3.2

Name or abbreviated title of the trial where available

OASIS 4

A.4.1

Sponsor's protocol code number

21656

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	Bayer Consumer Care AG
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	Bayer Consumer Care 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	Bayer AG
B.5.2	Functional name of contact point	Bayer Clinical Trials Contact
B.5.3	Address:
B.5.3.1	Street Address	CTP Team/ Ref:"EU CTR"/ Bayer AG
B.5.3.2	Town/ city	Berlin
B.5.3.3	Post code	13342
B.5.3.4	Country	Germany
B.5.4	Telephone number	+4930300139003
B.5.6	E-mail	clinical-trials-contact@bayer.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	BAY 3427080 SOFT CAPS 60 MG 001
D.3.2	Product code	BAY 3427080
D.3.4	Pharmaceutical form	Capsule, soft
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	Elinzanetant
D.3.9.1	CAS number	929046-33-3
D.3.9.2	Current sponsor code	BAY 3427080
D.3.9.3	Other descriptive name	formerly used NT-814
D.3.9.4	EV Substance Code	SUB216548
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	60
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, soft
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Vasomotor symptoms caused by adjuvant endocrine therapy in women with, or at high risk for developing hormone-receptor positive breast cancer

Síntomas vasomotores (SVM) causados terapia endocrina adyuvante en mujeres con cáncer de mama positivo a receptores hormonales o alto riesgo de desarrollarlo.

E.1.1.1

Medical condition in easily understood language

Hot flashes caused by anti-cancer therapy in women with, or at high risk for developing hormone-receptor positive breast cancer

Sofocos causados por la terapia anticancerígena en mujeres con cáncer de mama positivo a receptores hormonales o alto riesgo de desarrollarlo.

E.1.1.2

Therapeutic area

Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10022457
E.1.2	Term	Instability vasomotor
E.1.2	System Organ Class	100000004852

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10020407
E.1.2	Term	Hot flashes
E.1.2	System Organ Class	100000004866

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 evaluate the efficacy of elinzanetant for the treatment of vasomotor symptoms (VMS) caused by adjuvant endocrine therapy in women with, or at high risk for developing hormone receptor positive breast cancer

Evaluar la eficacia de Elinzanetant en el tratamiento de los SVM causados por hormonoterapia complementaria, en mujeres con cáncer de mama positivo a receptores hormonales o alto riesgo de desarrollarlo

E.2.2

Secondary objectives of the trial

1. To evaluate the onset of efficacy of elinzanetant for the treatment of VMS caused by adjuvant endocrine therapy in women with, or at high risk for developing hormone-receptor positive breast cancer.

2. To evaluate the efficacy of elinzanetant in women with, or at high risk for developing hormone receptor positive breast cancer on: sleep quality and menopause related quality of life.

3. To evaluate the safety of elinzanetant for the treatment of VMS caused by adjuvant endocrine therapy in women with, or at high risk for developing hormone receptor positive breast cancer.

1. Evaluar el inicio de la eficacia de Elinzanetant en el tratamiento de los SVM causados por hormonoterapia complementaria, en mujeres con cáncer de mama positivo a receptores hormonales o alto riesgo de desarrollarlo

2. Evaluar la eficacia de Elinzanetant en mujeres con cáncer de mama positivo a receptores hormonales o alto riesgo de desarrollarlo con respecto a: la calidad de sueño y la calidad de vida relacionada con la menopausia.

3. Evaluar la seguridad de Elinzanetant en el tratamiento de los SVM causados por hormonoterapia complementaria, en mujeres con cáncer de mama positivo a receptores hormonales o alto riesgo de desarrollarlo

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Females aged 18 to 70 years of age inclusive, at the time of signing the informed consent.

2.Women experiencing vasomotor symptoms (VMS) caused by adjuvant endocrine therapy that they are expected to use for the duration of the study

a. Tamoxifen (maximum daily dose of 20 mg) with or without the use of gonadotropin-releasing hormone (GnRH) analogues or

b. Aromatase inhibitors with or without the use of GnRH analogues

3. Women must have

a. a personal history of hormone-receptor positive breast cancer or

b. a high risk for developing breast cancer.

4. Participant has completed Hot Flash Daily Diary (HFDD) for at least 11 days during the two weeks preceding baseline visit, and participant has recorded at least 35 moderate to severe hot flash (HF) (including night-time HF) over the last 7 days that the HFDD was completed (assessed at the Baseline Visit).

5. Contraceptive use by [women except for post-menopausal women or Women of Non childbearing potential (WONCBP)] should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

1. Mujeres de 18 a 70 años, inclusive, en el momento de la firma del consentimiento informado.

2. Mujeres que experimentan SVM causados por la hormonoterapia complementaria que se prevé que usen mientras dure el ensayo.
a. Tamoxifeno (dosis diaria máxima de 20 mg) con o sin el uso de
análogos de GnRH o
b. inhibidores de la aromatasa con o sin el uso de análogos de GnRH.

3. Las mujeres deben tener

a. antecedentes personales de cáncer de mama con receptores hormonales o

b. un riesgo elevado de padecer cáncer de mama.

4. La participante debe haber completado el DSF durante al menos 11 días en las dos semanas anteriores a la visita inicial, y haber registrado al menos 35 SF de moderados a graves (incluidos SF nocturnos) durante los últimos 7 días en que se completó el DSF (evaluado en la visita basal).

5. El uso de métodos anticonceptivos por parte de las mujeres (excepto en el caso de mujeres posmenopáusicas o MNEF) debe concordar con las normativas locales con respecto a los métodos anticonceptivos para quienes participan en ensayos clínicos.

E.4

Principal exclusion criteria

1.Initial diagnosis of metastatic hormone-receptor positive breast cancer (stage IV) or recurrence under adjuvant endocrine therapy of hormone-receptor positive breast cancer.

2.Current or history (except complete remission for 5 years or more prior to signing informed consent) of any malignancy, except for hormone-receptor positive breast cancer (Stage 0-III), basal and squamous cell skin tumors.

3.Surgery or non-surgical (e.g., chemotherapy, radiotherapy, immunotherapy) treatment for breast cancer within the last 3 months prior to signing informed consent (except use of tamoxifen, aromatase inhibitors, GnRH analogues).

4. Any clinically significant prior or ongoing history of arrhythmias, heart block and QT prolongation either determined through clinical history or on electrocardiogram (ECG) evaluation.

5.Any active ongoing condition that could cause difficulty in interpreting VMS such as: infection that could cause pyrexia, pheochromocytoma, carcinoid syndrome.

6.Any unexplained vaginal bleeding.

7.Mammogram with clinically relevant malignant or suspicious findings that will require surgery, radiotherapy or chemotherapy as per local guidelines (mammogram should not be older than 12 months prior to signing informed consent). If a mammogram is not possible after partial mastectomy an ultrasound could be performed instead.

8.Disordered proliferative endometrium, endometrial hyperplasia, polyp, or endometrial cancer diagnosed based on endometrial biopsy during screening.

9.Current arterial or venous vascular event (e.g., Myocardial infarction (MI), Transient ischemic attack (TIA), stroke, deep vein thrombosis (DVT), i.e., within the last 6 months prior to signing informed consent.

1.Diagnóstico inicial de cáncer de mama metastásico con receptores hormonales (estadio IV) o recidiva bajo hormonoterapia complementaria del cáncer de mama con receptores hormonales.

2.Antecedentes actuales o pasados (excepto remisión completa durante 5 años o más antes de firmar el consentimiento informado) de algún tipo de neoplasia maligna, excepto cáncer de mama con receptores hormonales (estadio 0-III), tumores cutáneos de células basales y de células escamosas.

3. Tratamiento quirúrgico o no quirúrgico (p. ej., quimioterapia, radioterapia, inmunoterapia) para el cáncer de mama en los últimos 3 meses antes de firmar el consentimiento informado (excepto el uso de tamoxifeno, inhibidores de la aromatasa, análogos de GnRH).

4. Antecedentes o presencia actual de arritmias, bloqueo cardíaco y prolongación del intervalo QT de importancia clínica, determinados por medio de la historia clínica o bien en la evaluación electrocardiográfica.

5. Cualquier afección activa en curso que pueda causar dificultad en la interpretación de los SVM, como: infección que podría causar fiebre, feocromocitoma, síndrome carcinoide.

6. Algún sangrado vaginal inexplicable.

7. Mamografía con hallazgos malignos o sospechosos clínicamente relevantes que requerirán cirugía, radioterapia o quimioterapia según las pautas locales (la mamografía no debe haberse realizado más de 12 meses antes de firmar el consentimiento informado). Si no es posible realizar una mamografía después de una mastectomía parcial, se puede realizar una ecografía.

8. Endometrio proliferativo desordenado, hiperplasia endometrial, pólipo o cáncer de endometrio diagnosticado en base a una biopsia endometrial durante la selección.

9. Acontecimiento vascular arterial o venoso actual (p. ej., IM, AIT, accidente cerebrovascular, TVP), es decir, en los últimos 6 meses antes de firmar el consentimiento informado.

E.5 End points

E.5.1

Primary end point(s)

1. Mean change in frequency of moderate to severe hot flash (HF) from baseline to Week 4 (assessed by hot flash daily diary [HFDD]).

2. Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD).

1. Cambio medio en la frecuencia de sofocos moderados a graves desde la visita basal hasta la semana 4 (evaluado en función del Diario de Sofocos [DSF]).

2. Cambio medio en la frecuencia de sofocos moderados a graves desde la visita basal hasta la semana 12 (evaluado en función del DSF).

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Baseline to Week 4.
2. Baseline to Week 12

1. Desde Visita Basal hasta la semana 4
2. Desde Visita Basal hasta la semana 12

E.5.2

Secondary end point(s)

1. Mean change in severity of moderate to severe HF from baseline to Week 4 (assessed by HFDD).
2. Mean change in severity of moderate to severe HF from baseline to Week 12 (assessed by HFDD).
3. Mean change in frequency of moderate to severe HF from baseline to Week 1 (assessed by HFDD).
4. Mean change in frequency of moderate to severe HF from baseline over time.
5. Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total score from baseline to Week 12.
6. Mean change in menopause specific quality of life scale (MENQOL) total score from baseline to Week 12.

1. Cambio medio en la gravedad de sofocos moderados a graves desde la visita basal hasta la semana 4 (evaluado en función del DSF).
2. Cambio medio en la gravedad de sofocos moderados a graves desde la visita basal hasta la semana 12 (evaluado en función del DSF).
3. Cambio medio en la frecuencia de sofocos moderados a graves desde la visita basal hasta la semana 1 (evaluado en función del DSF).
4. Cambio medio en la frecuencia de sofocos moderados a graves con el tiempo desde la visita basal .
5. Cambio medio en la puntuación total del formulario breve del sistema de información de medición de los resultados percibidos por el paciente con respecto a los trastornos del sueño 8b (PROMIS SD SF 8b) desde la visita basal hasta la semana 12.
6. Cambio medio en la puntuación total de escala de calidad de vida específica de la menopausia (MENQOL) desde la visita basal hasta la semana 12.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Baseline to Week 4.
2. Baseline to Week 12.
3. Baseline to Week 1.
4. Baseline to week 56.
5. Baseline to Week 12.
6. Baseline to Week 12.

1. Desde Visita Basal hasta la semana 4
2. Desde Visita Basal hasta la semana 12
3. Desde Visita Basal hasta la semana 1
4. Desde Visita Basal hasta la semana 56
5. Desde Visita Basal hasta la semana 12
6. Desde Visita Basal hasta la semana 12

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

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

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

Israel

Russian Federation

United Kingdom

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

The end of the study is defined as the date of the last scheduled visit of the last participant in the study globally.

El fin de estudio se define como la fecha de la ultima visita programada del último participante en el estudio a nivel mundial.

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:

305

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

100

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

355

F.4.2.2

In the whole clinical trial

405

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

2022-09-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-09-06

P. End of Trial
P.	End of Trial Status	Ongoing

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