Clinical Trials Register

Summary
EudraCT Number:	2020-000428-21
Sponsor's Protocol Code Number:	EUROPATRIAL
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-02-10
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2020-000428-21

A.3

Full title of the trial

ExclUsive endocRine therapy Or Partial breast irradiation for women aged =70 years with luminal A-like early stage breast cancer (EUROPA): a randomized phase 3 non-inferiority trial.

Terapia endocrina o irradiazione parziale della mammella come trattamento postoperatorio esclusivo in donne di età =70 anni affette da tumore mammario di tipo luminale-A in stadio iniziale: studio di fase 3 randomizzato di non inferiorità.

A.3.1

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

Exclusive hormonal therapy or exclusive irradiation of a small volume of operated breast for older adults aged >=70 years affected by low risk early stage breast cancer (EUROPA): a randomized noon inferiority phase 3 controlled trial.

Studio di fase III, randomizzato di non inferiortà, controllato, multicentrico a due bracci, terapia endocrina vs irradiazione parziale della mammella, in pazienti con età uguale o superiore a 70 anni luminale-A in stadio iniziale.

A.3.2

Name or abbreviated title of the trial where available

EUROPA TRIAL

A.4.1

Sponsor's protocol code number

EUROPATRIAL

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT04134598

A.5.4

Other Identifiers

Name:

EUROPA TRIAL

Number:

NCT04134598

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	DIPARTIMENTO DI SCIENZE BIOMEDICHE SPERIMENTALI E CLINICHE, UNIVERSITà DI FIRENZE
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	RADIOTERAPIA ONCOLOGICA
B.5.2	Functional name of contact point	DATA MANAGER
B.5.3	Address:
B.5.3.1	Street Address	Largo Brambilla 3, Firenze
B.5.3.2	Town/ city	FIRENZE
B.5.3.3	Post code	50134
B.5.3.4	Country	Italy
B.5.4	Telephone number	0557947192
B.5.5	Fax number	0552751835
B.5.6	E-mail	datamanager.ng.rt@sbsc.unifi.it

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.2.1.2	Country which granted the Marketing Authorisation	Italy
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	ANASTROZOLO
D.3.2	Product code	[039608017 fonte: https://www.fogliettoillustrativ
D.3.4	Pharmaceutical form	Film-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	ANASTROZOLO
D.3.9.2	Current sponsor code	NON APPLICABILE
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	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.2.1.2	Country which granted the Marketing Authorisation	Italy
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	LETROZOLO
D.3.2	Product code	[033242013]
D.3.4	Pharmaceutical form	Film-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	LETROZOLO
D.3.9.2	Current sponsor code	NON APPLICABILE
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	2
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	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	Italy
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	TAMOXIFENE
D.3.2	Product code	[033688021]
D.3.4	Pharmaceutical form	Film-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	TAMOXIFENE CITRATO
D.3.9.2	Current sponsor code	NON APPLICABILE
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	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.2.1.2	Country which granted the Marketing Authorisation	Italy
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	EXEMESTANE
D.3.2	Product code	[040535041]
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	EXEMESTANE
D.3.9.2	Current sponsor code	non applicabile
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	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

Patients aged >=70 years with T1 N0 breast cancer (dimensions <2 cm and negative axillary lymph nodes) with luminal A-like characteristics (ER >=10% PgR >20% HER2 negative Ki67 <20%), after conservative surgery amenable with postoperative partial breast irradiation. The aim of the study is to evaluate the health-related quality of life (HRQoL) and safety of the irradiation arm.

Pazienti con età uguale o superiore a 70 anni con tumore della mammella T1 N0 (dimensioni fino a 2 cm e linfonodi ascellari negativi) luminale A-like (ER >=10% PgR >20% HER2 negativo Ki67 <20%), dopo chirurgia conservativa, candidabili a radioterapia postoperatoria e terapia endocrina adiuvante. Lo studio si propone di valutare la qualità della vita e la sicurezza dell’irradiazione parziale della mammella esclusiva in questa popolazione di pazienti potenzialmente fragile.

E.1.1.1

Medical condition in easily understood language

Patients aged >= 70 years with small and good prognosis tumors after conservative surgery amenable with postoperative irradiation and endocrine therapy.

Pazienti affette da neoplasie della mammella di piccole dimensioni e buona prognosi sottoposte a chirurgia conservativa candidabili ad un trattamento radiante e terapia ormonale postoperatoria.

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	20.0
E.1.2	Level	SOC
E.1.2	Classification code	10029104
E.1.2	Term	Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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 the PROMs HRQoL, as assessed by the QLQ-C30 [47] and module BR45 questionnaires [48], of exclusive PBI as compared to exclusive ET after BCS in low-risk early BC patients aged =70 years
- To determine the IBTR rate of exclusive PBI as compared to exclusive ET after BCS in low-risk early BC patients aged =70 years.

- Valutazione della qualità della vita attraverso i Patient Reported Outcome Measures (PROMs) mediante questionari validati EORTC QLQ-C30 e i moduli QLQ-BR45

- Valutazione del tempo alla recidiva tumorale ipsilaterale (IBTR) a 5 anni dalla randomizzazione.

E.2.2

Secondary objectives of the trial

Secondary Objectives:
- Safety, as assessed by the number and grade of participants with reported AEs;
- individual scales from QLQ-C30 and module QLQ-BR45 scores [47,48];
- PROMs HRQoL measured by ELD14 questionnaire [43];
- G-CODE assessment [41];

Obiettivi secondari:
- Sicurezza del trattamento, valutata attraverso il numero ed il grado degli eventi avversi riportati dalle pazienti;
- valutazione individuale dell’evoluzione dei questionari QLQ-C30 e QLQ-BR45 al baseline, 3, 6, 12, 24 mesi e 5 anni;
- valutazione dei PROMs attraverso la misurazione della qualità della vita mediante il questionario QLQ-ELD14 al baseline, 3, 12, e 24 mesi;
- valutazione multidimensionale geriatrica tramite G-CODE al baseline e a 24 mesi;
- valutazione della cosmesi al baseline, 3, 6, 12, 24 mesi e 5 anni;
- valutazione del tempo alla recidiva locoregionale (LRR), sviluppo di tumore mammario controlaterale (CBC) e sviluppo di metastasi a distanza (DM) a 5 anni;
- sopravvivenza cancro-specifica per tumore della mammella (BCSS) e sopravvivenza globale (OS) a 5 anni.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- - Women aged >=70 years;
- histologically proven invasive unifocal adenocarcinoma of the breast;
- pathological T1 (pT1) stage;
- postoperative negative (no ink) final surgical margins;
- clinical and pathological N0 (cN0 and pN0) stage (isolated tumour cells [i+] allowed);
- any tumour grade (if pT =10 mm), G1-2 tumour grade (if pT between 11 and 19 mm);
- luminal A-like biology (immunohistochemistry (IHC)-based on local assessment [49]):
- ER positive (defined as =10%);
- Progesterone (PgR) positive (defined as >20%);
- Human epidermal growth factor receptor 2 (HER2) negative (score 0 or 1+ and proven negative by in-situ hybridization [ISH] in case of score 2+); and
- Ki67 <20% by IHC staining;
- surgically treated with BCS with or without sentinel node biopsy (SNB);
- written informed consent

Principali criteri di inclusione
- Donne di età maggiore o uguale a 70 anni;
- conferma istologica di adenocarcinoma mammario invasivo unifocale;
- stadio patologico T1 (pT1);
- margini chirurgici postoperatori negativi (no ink);
- stadio clinico e patologico N0 (cN0 e pN0) (isolate cellule tumorali [i+] sono consentite);
- qualsiasi grado tumorale (se pT =10 mm), grado G1-2 (se pT tra 11 e 19 mm);
- biologia luminale A-like [basata sull’immunoistochimica (IHC) valutata a livello locale: ER+ (definite come =10%), PgR+ (>20%), HER2 negativo, Ki67 =20%];
- chirurgia conservativa con o senza biopsia del linfonodo sentinella (BLS);
- consenso informato firmato prima dell’arruolamento.

E.4

Principal exclusion criteria

- Clinical evidence of DM or LR at baseline;
- preoperative systemic treatments (i. e., chemotherapy, endocrine therapy);
- current treatment with any hormonal agents such as tamoxifen, raloxifene, or other selective oestrogen receptor modulators (SERMs), either for osteoporosis or BC prevention (patients are eligible if these medications are discontinued prior to
randomization);
- known disorders associated with a higher risk for complications following RT such as collagen vascular disease, dermatomyositis, systemic lupus erythematosus or scleroderma;
- any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
- any serious uncontrolled medical disorder, non-malignant systemic disease, or active uncontrolled infection. Examples include but are not limited to uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction or uncontrolled
major seizure disorder
- no other cancers in the last 5 years (except basal or squamous cell carcinoma of the skin that has been definitely treated), unless in clinical remission at the time of randomization.

• Terapia sistemica preoperatoria (chemioterapia, terapia endocrina).
• Attuale trattamento con un agente ormonale come tamoxifene, raloxifene o un altro modulatore dei recettori estrogenici, sia per la prevenzione dell’osteoporosi che del tumore della mammella (le pazienti risultano eleggibili se questi farmaci vengono
interrotti prima della randomizzazione).
• Disordini associati ad un elevato rischio di complicanze da radioterapia, come patologie del collageno, dermatomiosite, lupus eritematoso sistemico o sclerodermia
• Precedente diagnosi o trattamento di un’altra neoplasia maligna (ad eccezione di basalioma o carcinoma a cellule squamose cutaneo trattato in maniera definitiva) negli ultimi 5 anni o in remissione clinica al tempo della randomizzazione
• Qualsiasi condizione psicologica, familiare, sociologica o geografica potenzialmente determinante difficoltà nella compliance allo studio; queste condizioni devono essere discusse con la paziente prima dell’arruolamento.
• Pazienti con patologie mediche, malattie sistemiche non oncologiche, o infezioni attive non controllate.
° Nessun altra patologia tumorale negli ultimi 5 anni ( escluso carcinoma squamoso della pelle definitivamente trattato)

E.5 End points

E.5.1

Primary end point(s)

Primary endpoints
- PROMs HRQoL measured by global quality of life score (QLQ-C30) using the GHS, assessed at baseline, 3- , 6- , 12- , 24-month;
- time to IBTR at 5-year.

- Valutazione della qualità della vita attraverso i Patient Reported Outcome Measures (PROMs) mediante questionari validati confrontati al baseline, 3-, 6-, 12- e 24 mesi.

- Tasso di recidiva mammella omolaterale a 5 anni

E.5.1.1

Timepoint(s) of evaluation of this end point

The primary analysis population is the intention-to-treat (ITT) population. The primary analysis will be undertaken when all patients have reached the 5-year analysis time point after randomization.

La popolazione di analisi primaria è la popolazione intent-to-treat (ITT). L'analisi primaria verrà intrapresa quando tutti i pazienti avranno raggiunto il punto temporale di analisi di 5 anni dopo la randomizzazione.

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

E.6.4

Safety

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)

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

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

Terapia endocrina

Endocrine therapy

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

The duration of participation in the study is 10 years. During this period, periodic clinical-instrumental evaluations will be scheduled and the quality of life questionnaires will be administered to patients after 3, 6, 12 and 24 months and 5 years from enrollment. There are no additional tests compared to the therapeutic-care standard.

La durata della partecipazione allo studio è di 10 anni. Durante questo periodo, verranno programmate delle valutazioni clinico-strumentali a cadenza periodica e verranno somministrati alle pazienti i questionari sulla qualità di vita dopo 3, 6, 12 e 24 mesi e 5 anni dall’arruolamento. Non sono previsti esami aggiuntivi rispetto allo standard terapeutico-assistenziale

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

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)

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

962

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

962

F.4.2

For a multinational trial

F.4.2.1

In the EEA

962

F.4.2.2

In the whole clinical trial

962

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)

Patients will be followed up with clinico-instrumental workout following international guidelines for breast cancer.

I pazienti proseguiranno con il follow up clinico strumentale come da pratica clinica internazionale per le neoplasie mammarie.

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

2020-09-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-01-19

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

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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