Clinical Trials Register

Summary
EudraCT Number:	2014-002602-20
Sponsor's Protocol Code Number:	IRST174.09
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:	2014-08-04
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

2014-002602-20

A.3

Full title of the trial

CLINICAL AND TRASLATIONAL PHASE II STUDY OF LIPOSOMAL DOXORUBICIN PLUS DOCETAXEL AND TRASTUZUMAB WITH METFORMIN AS PRIMARY SYSTEMIC THERAPY FOR OPERABLE AND LOCALLY ADVANCED HER2 POSITIVE BREAST CANCER.

Studio clinico e traslazionale di fase II con Doxorubicina Liposomiale (Myocet) più Docetaxel, Trastuzumab e Metformina come terapia sistemica primaria per il cancro della mammella operabile e localmente avanzato Her-2 positivo

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

met-HEReMYTA

A.4.1

Sponsor's protocol code number

IRST174.09

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	ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI IRST - IRCCS
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	IRST-IRCCS
B.4.2	Country	Italy
B.4.1	Name of organisation providing support	TEVA Pharma B.V.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	IRST - IRCCS
B.5.2	Functional name of contact point	Centro di Coordinamento Studi IRST
B.5.3	Address:
B.5.3.1	Street Address	Dipartimento di Oncologia ed Ematologia, Ospedale Civile S. Maria delle Croci, viale Randi, 5
B.5.3.2	Town/ city	Ravenna
B.5.3.3	Post code	47121
B.5.3.4	Country	Italy
B.5.4	Telephone number	+390544285813
B.5.5	Fax number	+390544285330
B.5.6	E-mail	cc.ubsc@irst.emr.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.2.1.1.1	Trade name	Myocet
D.2.1.1.2	Name of the Marketing Authorisation holder	Teva Pharma B.V.
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.3.4	Pharmaceutical form	Powder, dispersion and solvent for concentrate for dispersion for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NA
D.3.9.1	CAS number	23214-92-8
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	LIPOSOMAL DOXORUBICIN HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB126795
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	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	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.3.4	Pharmaceutical form	Concentrate and solvent for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ND
D.3.9.1	CAS number	114977-28-5
D.3.9.2	Current sponsor code	ND
D.3.9.3	Other descriptive name	DOCETAXEL
D.3.9.4	EV Substance Code	SUB12492MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	HERCEPTIN
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited
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.3.4	Pharmaceutical form	Powder for concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TRASTUZUMAB
D.3.9.1	CAS number	180288-69-1
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB12612MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	21
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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.3.4	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	METFORMIN
D.3.9.1	CAS number	657-24-9
D.3.9.2	Current sponsor code	ND
D.3.9.3	Other descriptive name	ND
D.3.9.4	EV Substance Code	SUB08831MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 5
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	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	3'-desosssi-3'-[F-18] fluorotimidina (FLT)
D.3.2	Product code	18F-FLT
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	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NA
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	FLUOROTHYMIDINE F-18
D.3.9.4	EV Substance Code	SUB33646
D.3.10	Strength
D.3.10.1	Concentration unit	MBq megabecquerel(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	100 to 200
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	Yes
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

OPERABLE AND LOCALLY ADVANCED HER2 POSITIVE BREAST CANCER.

Pazienti con tumore alla mammella HER2-positivo, operabile e localmente avanzato.

E.1.1.1

Medical condition in easily understood language

OPERABLE AND LOCALLY ADVANCED HER2 POSITIVE BREAST CANCER.

Pazienti con tumore alla mammella HER2-positivo, operabile e localmente avanzato.

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	17.0
E.1.2	Level	PT
E.1.2	Classification code	10006187
E.1.2	Term	Breast cancer
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 evaluate the pathologic complete response rate (pCR).

Valutare il tasso di risposta patologica completa (pCR)

E.2.2

Secondary objectives of the trial

- to evaluate the clinical response rate (RR).
- to evaluate the feasibility and systemic tolerance, with particular attention to cardiac toxicity.
- to evaluate the conservative surgery rate.

• Valutare il tasso di risposta clinica (RR)
• Valutare la fattibilità e la tolleranza sistemica, con particolare attenzione alla tossicità cardiaca.
• Valutare il tasso di chirurgia conservativa.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

a) To evaluate early responses by 3'-desosssi-3'-[18F] fluorotimidina (FLT)-PET
OBJECTIVE: To evaluate early predictive value of 3'-desossi-3'-
[18F] fluorothymidine (FLT)-PET on pCR

b) To evaluate early responses to chemotherapy by breast MRI
OBJECTIVE: To evaluate early predictive value of Breast MRI.

c) To qualitatively and quantitatively characterize immune response at both blood and tumor tissue level
OBJECTIVE: To evaluate the predictive and prognostic value of
circulating and intratumor immune response.

d) To evaluate the modulation of miRNAs-29 operated by metformin.
OBJECTIVE:To evaluate the modulation of miRNAs-29
operated by metformin.

Date and version: 24 June 2014, Final Version

a) 3’-desossi-3’-[18F] fluoro timidina FLT) – PET
OBIETTIVO: Valutare il valore predittivo precoce di 3'-desossi-3'-[18F] fluorothymidine (FLT)-PET su pCR.

b) Diffusion-weighted breast MRI
OBIETTIVO: Valutare il valore predittivo precoce di MRI del seno.

c) miRNAs expression
OBIETTIVO:Valutare la modulazione dei miRNA-29 operata dalla metformina.

d) Immunological response evaluation
OBIETTIVO: Valutare il valore predittivo e prognostico della risposta immunitaria circolante e intratumorale.

Data e versione: 24 Giugno 2014, Versione Finale

E.3

Principal inclusion criteria

1. Patients must have histologically confirmed breast cancer
2. HER2 overexpressing cancer
3. Patients with operable breast cancer (T1c and citologically N1-2, or cT2-3, N0-N2, M0) or locally advanced breast cancer (T4a-d, N0-N2, M0) (AJCC 7th edition 2010).
4. Both sexes, age ≥ 18 years and < 75 years
5. ECOG performance status 0-1
6. Life expectancy > 3 months
7. Neutrophil count ≥ 2 x 109/ L, leukocytes count ≥ 3 x 109/ L and PLT ≥ 100 x 109/ L
8. Total bilirubin ≤ 1 upper-normal limits (UNL) of the Institutional normal values and ASAT (GOT) and/or ALAT (GPT) ≤ 2.5 UNL, alkaline
phosphatase ≤ 5 UNL. Patients with ASAT and/or ALAT > 1.5 UNL and alkaline phosphatase > 2.5 UNL aren’t elegible for the trial.
9. Creatinine ≤ 1.5 mg/dL
10. Left ventricular ejection fraction (LVEF) ≥ 50% (evaluated by echocardiogram or MUGA scan – only one method must be employed for each patient)
11. Written informed consent
12. Homa Index calculated using the Matthews’ formula (Appendix B)

1. Pazienti con cancro al seno, confermato istologicamente.
2. Cancro con sovra espressione della proteina HER2.
3. Pazienti con cancro alla mammella operabile (T1c e citologicamente N1 - N2, o cT2-3, N0 – N2, M0) o localmente avanzato (T4a-d, N0 – N2, M0) (AJCC 7th edizione 2010).
4. 18≥ età < 75, entrambi i sessi.
5. ECOG performance status 0-1.
6. Aspettativa di vita > 3 mesi.
7. Conta dei neutrofili ≥ 2 x 109/ L, conta leucocitaria ≥ 3 x 109/ L e PLT ≥ 100 x 109/ L.
8. Bilirubina totale ≤ 1 upper-normal limits (UNL) dei valori normali Istituzionali e ASAT (GOT) e/o ALAT (GPT) ≤ 2.5 UNL, fosfatasi alcalina ≤ 5 UNL. Pazienti con ASAT e/o ALAT > 1.5 UNL e fosfatasi alcalina > 2.5 UNL non sono eleggibili per questo studio.
9. Creatinina ≤ 1.5 mg/dL.
10. LVEF (left ventricular ejection fraction) ≥ 50% (valutata con ecocardiogramma o MUGA scan – per ogni paziente deve essere impiegata una sola metodologia).
11. Consenso informato firmato.
12. Homa Index calcolato secondo la formula di Matthews (Appendice B del protocollo).

E.4

Principal exclusion criteria

1. Prior chemotherapy or radiotherapy for breast cancer.
2. History of prior malignancy in the last 10 years (other than non-melanoma skin cancer or excised cervical carcinoma in situ).
3. Other serious illness or medical condition
4. Congestive heart failure or angina pectoris even if medically controlled. Previous history of myocardial infarction, uncontrolled high risk hypertension or arrhythmia
5. History of significant neurologic or psychiatric disorders including dementia or seizures
6. Active infection
7. Concurrent treatment with other experimental drugs.
8. Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
9. Geographic inaccessibility to treatment and followup
10. Pregnant and lactating women
11. Patients with severe dyspnoea at rest due to massive pulmonary involvement by the tumor or who require supplemental oxygen therapy
12. Diabetes-insulin dependent and non insulindependent

1. Precedente chemioterapia o radioterapia per tumore alla
mammella.
2. Precedente tumore maligno negli ultimi 10 anni (diverso dal tumore cutaneo non-melanoma o carcinoma della cervice in situ asportato).
3. Altre malattie o condizioni mediche gravi
4. Insufficienza cardiaca congestizia o angina pectoris, anche se controllata. Storia precedente d’infarto del miocardio, ipertensione non controllata ad alto rischio o aritmia.
5. Disturbi neurologici o psichiatrici significativi, tra cui la demenza o le convulsioni.
6. Infezione attiva
7. Trattamento concomitante con altri farmaci sperimentali.
8. Partecipazione a un altro studio clinico con eventuali farmaci sperimentali nei 30 giorni precedenti allo screening dello studio.
9. Inaccessibilità geografica al trattamento ed ai follow-up.
10. Donne in gravidanza e in allattamento
11. Pazienti con grave dispnea a riposo a causa di massiccio coinvolgimento polmonare del tumore o che necessitano di una terapia di ossigeno supplementare.
12. Diabete insulino-dipendente e non insulino-dipendente

E.5 End points

E.5.1

Primary end point(s)

Pathologic complete response rate (pCR).

Tasso di risposta patologica completa (pCR).

E.5.1.1

Timepoint(s) of evaluation of this end point

42 months

42 mesi

E.5.2

Secondary end point(s)

· To evaluate the clinical response rate (RR).
· To evaluate the feasibility and systemic tolerance, with particular attention to cardiac toxicity
· To evaluate the conservative surgery rate.

E.5.2.1

Timepoint(s) of evaluation of this end point

42 months

42 mesi

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

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

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

LVLS

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

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

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.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)

All patients will undergo surgery.
Radiotherapy and Chemotherapy / hormonal adjuvant therapy will be performed according to standard practice guidelines.
Herceptin will be continued 3 weekly until completion of 52 weeks of treatment.
Follow-up visits: cardiac evaluation and annually mammography.

Tutti i pazienti saranno sottoposti a chirurgia. La radioterapia e la chemioterapia / terapia ormonale adiuvante verranno effettuate secondo le linee guida standard. L’herceptin proseguirà ogni 3 settimane per 52 settimane totali.
Visite di follow-up: valutazioni cardiache e mammografia annuale.

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

2014-09-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-07-17

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

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IMP with orphan designation in the indication
Orphan Designation Number:
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