Clinical Trials Register

Summary
EudraCT Number:	2022-000095-18
Sponsor's Protocol Code Number:	21656
National Competent Authority:	Portugal - INFARMED
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2022-07-27
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Portugal - INFARMED

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

Ensaio multicêntrico, em dupla ocultação, aleatorizado e controlado por placebo para investigar a eficácia e a segurança de elinzanetant para o tratamento de sintomas vasomotores causados por terapêutica endócrina adjuvante, ao longo de 52 semanas em mulheres com, ou com elevado risco de desenvolver, cancro da mama positivo para recetores hormonais

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

Um ensaio para saber mais sobre o funcionamento do elinzanetant e a sua segurança em comparação com um placebo, no tratamento dos sintomas vasomotores (afrontamentos) causados por terapêutica anti-cancerígena em mulheres com, ou com elevado risco de desenvolver, cancro da mama positivo para recetores hormonais

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

Sintomas vasomotores causados por terapêutica endócrina adjuvante em mulheres com, ou com elevado risco de desenvolver, cancro da mama positivo para recetores hormonais.

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

Afrontamentos causados por terapêutica anti-neoplásica em mulheres com, ou com elevado risco de desenvolver, cancro da mama positivo para recetores hormonais

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

Avaliar a eficácia de elinzanetant para o tratamento de sintomas vasomotores (VMS) causados por terapêutica endócrina adjuvante em mulheres com, ou com elevado risco de desenvolver, cancro da mama positivo para recetores hormonais

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. Avaliar o início da eficácia de elinzanetant para o tratamento de VMS causados por terapêutica endócrina adjuvante

em mulheres com, ou com elevado risco de desenvolver cancro da mama positivo para receptores hormonais

2. Avaliar a eficácia de elinzanetant em mulheres com, ou com elevado risco de desenvolver, cancro da mama positivo para recetores hormonais na: qualidade do sono e qualidade de vida relacionada com a menopausa

3. Avaliar a segurança de elinzanetant para o tratamento de VMS causados por terapêutica endócrina adjuvante em mulheres com, ou com elevado risco de desenvolver, cancro da mama positivo para recetores hormonais

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. Mulheres de 18 a 70 anos, inclusive, na assinatura do Formulário de Consentimento Informado.

2. Mulheres que apresentem sintomas vasomotores (VMS) causados por terapêutica endócrina, expectável de continuar a ser utilizada durante o ensaio

a. Tamoxifeno (dose diária máxima de 20 mg) com ou sem utilização de análogos da harmona de libertação da gonadotrofina (GnRH) ou

b. Inibidores da aromatase com ou sem a utilização de análogos da GnRH

3. As mulheres têm de ter

a. histórico pessoal de cancro da mama positivo para recetores hormonais ou

b. um risco elevado de desenvolverem cancro da mama.

4. A participante preencheu o Diário de Afrontamentos (HFDD) por pelo
menos 11 dias durante as duas semanas anteriores à visita inicial, e a participante registou pelo menos 35 afrontamentos (HF) moderados ou graves (incluindo HF noturnos) nos últimos 7 dias em que o HFDD foi preenchido (avaliado na Visita Inicial)

5. O método contracetivo utilizado deve estar de acordo com a regulamentação local relativa a métodos contracetivos para participantes em ensaios clínicos [exceto mulheres pós-menopáusicas ou não férteis (Women of Non childbearing potencial - WONCBP].

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 cancro da mama metastático positivo para recetores hormonais (Estadio IV) ou recorrência sob terapia endócrina adjuvante de cancro da mama positivo para recetores hormonais.

2. História atual ou prévia (exceto remissão completa há pelo menos 5 anos antes da assinatura do Formulário de Consentimento Informado) de qualquer malignidade, cancro da mama positivo para recetores hormonais (Estadios 0-III), tumores de pele de células escamosas e basais.

3. Tratamento cirúrgico ou não cirúrgico (por exemplo, quimioterapia, radioterapia, imunoterapia) para cancro da mama nos últimos 3 meses antes assinatura do Formulário de Consentimento Informado (exceto utilização de tamoxifeno, inibidores da aromatase, análogos da GnRH).

4. Qualquer história clinicamente significativa anterior ou em curso de arritmias, bloqueio cardíaco e prolongamento do intervalo QT determinado através da
história clínica ou na avaliação do eletrocardiograma (ECG).

5. Qualquer condição ativa que possa causar dificuldade na interpretação doa VMS, como: infeção que possa causar pirexia, feocromocitoma, síndrome carcinoide.

6. Qualquer hemorragia vaginal inexplicável.

7. Mamografia com achados malignos ou suspeitos clinicamente relevantes que exigirão cirurgia, radioterapia ou quimioterapia de acordo com as orientações locais (a mamografia não deve ter mais de 12 meses antes da assinatura do Formulário de Consentimento Informado). Se não for possível realizar uma mamografia após a mastectomia parcial, de ser feita uma ecografia.

8. Endométrio proliferativo desordenado, hiperplasia endometrial, pólipos ou cancro endometrial diagnosticado com base na biópsia endometrial durante a seleção.

9. Evento vascular arterial ou venoso atual (por exemplo, enfarte do miocárdio (IM), acidente isquémico transitório (AIT), acidente vascular cerebral, trombose venosa profunda (TVP), ou seja, nos últimos 6 meses antes da assinatura do Formulário de Consentimento 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. Alteração média na frequência de afrontamentos (HF) moderados a graves desde o início do estudo até à semana 4 (avaliada pelo HFDD)
2. Alteração média na frequência de HF moderados a graves desde o início do estudo até à semana 12 (avaliada pelo HFDD)

E.5.1.1

Timepoint(s) of evaluation of this end point

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

1. Desde o início até à semana 4
2. Desde o início até à 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. Alteração média na gravidade de HF moderados a graves desde o início do estudo até à semana 4 (avaliada pelo HFDD)
2. Alteração média na gravidade de HF moderados a graves desde o início do estudo até à semana 12 (avaliada pelo HFDD)
3. Alteração média na frequência de HF moderados a graves desde o início do estudo até à semana 1 (avaliada pelo HFDD)
4. Alteração média na frequência de HF moderados a graves desde o início do estudo ao longo do tempo (avaliada pelo HFDD)
5. Alteração média na pontuação total da obtida no formulário abreviado de perturbação do sono (PROMIS SD SF 8b) desde o início do estudo até à semana 12
6. Alteração média na pontuação total da escala de qualidade de vida específica da menopausa (MENQOL)) desde o início do estudo até à 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 o início até à semana 4
2. Desde o início até à semana 12
3. Desde o início até à semana 1
4. Desde o início até à semana 56
5. Desde o início até à semana 12
6. Desde o início até à 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.

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

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

2022-12-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-08-26

P. End of Trial
P.	End of Trial Status	Trial now transitioned

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials