Clinical Trials Register

Summary
EudraCT Number:	2005-002868-28
Sponsor's Protocol Code Number:	D6995C00006
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2007-01-10
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2005-002868-28

A.3

Full title of the trial

A Randomised, Open-Label, Parallel-Group, Multi-centre, Phase II Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500mg with Anastrozole (ARIMIDEX™) 1mg as First Line Hormonal Treatment for Postmenopausal Women with Hormone Receptor Positive Advanced Breast Cancer

Studio clinico di fase II, randomizzato, in aperto, a gruppi paralleli, multicentrico, di confronto tra fulvestrant (FASLODEXTM) 500mg e anastrozolo (ARIMIDEXTM) 1mg, in termini di efficacia e tollerabilita`, come trattamento ormonale di prima linea per donne in menopausa con tumore della mammella in fase avanzata con recettori per gli estrogeni positivi

A.3.2

Name or abbreviated title of the trial where available

FIRST STUDY

STUDIO FIRST

A.4.1

Sponsor's protocol code number

D6995C00006

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	ASTRAZENECA
B.1.3.4	Country	Italy
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	ASTRAZENECA
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	ASTRAZENECA
B.5.2	Functional name of contact point	ASTRAZENECA
B.5.3	Address:
B.5.3.1	Street Address	PALAZZO VOLTA VIA FRANCESCO SFORZA
B.5.3.2	Town/ city	BASIGLIO
B.5.3.3	Post code	20080
B.5.3.4	Country	Italy
B.5.4	Telephone number	029801 1
B.5.5	Fax number	029801 1
B.5.6	E-mail	FLORE.LATOUR@ASTRAZENECA.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	FULVESTRANT
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Fulvestrant
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.3	Concentration number	250
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Non Applicabile
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	ARIMIDEX*28CPR 1MG
D.2.1.1.2	Name of the Marketing Authorisation holder	ASTRAZENECA SpA *
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	Anastrozole
D.3.9.1	CAS number	120511-73-1
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.3	Concentration number	1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Non Applicabile

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

Hormone Receptor Positive Advanced Breast Cancer

Tumore della mammella allo stadio avanzato con recettori per gli estrogeni positivi

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	14.1
E.1.2	Level	PT
E.1.2	Classification code	10057654
E.1.2	Term	Breast cancer female
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 compare the clinical benefit rate of patients treated with fulvestrant 500 mg with the clinical benefit rate of patients treated with anastrozole 1 mg

Confrontare la percentuale di beneficio clinico pazienti trattate con fulvestrant 500mg con la percentuale di beneficio clinico delle pazienti trattate con anastrozolo 1mg

E.2.2

Secondary objectives of the trial

1.To compare the objective response rate of patients treated with fulvestrant 500 mg with the objective response rate of patients treated with anastrozole 1 mg
2.To compare the time to progression of patients treated with fulvestrant 500 mg with the time to progression of patients treated with anastrozole 1 mg
3.To describe the duration of response of patients treated with fulvestrant 500 mg and the duration of response of patients treated with anastrozole 1 mg.
4.To describe the duration of clinical benefit of patients treated with fulvestrant 500 mg and the duration of clinical benefit of patients treated with anastrozole 1 mg.
5.To assess the safety and tolerability of fulvestrant 500 mg treatment compared with anastrozole 1 mg treatment

1.Confrontare la percentuale di risposta obiettiva delle pazienti trattate con fulvestrant 500mg con quella delle pazienti trattate con anastrozolo 1mg
2.Confrontare il tempo della progressione delle pazienti trattate con fulvestrant 500mg con quello delle pazienti trattate con anastrozolo 1mg
3.Descrivere la durata della risposta delle pazienti trattate con fulvestrant 500mg e quella delle pazienti trattate con anastrozolo 1mg
4.Descrivere la durata del beneficio clinico delle pazienti trattate con fulvestrant 500mg e quella delle pazienti trattate con anastrozolo 1mg
5.Valutare la sicurezza e la tollerabilita' del trattamento con fulvestrant 500mg rispetto a quella del trattamento con anastrozolo 1mg

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Postmenopausal woman
2.Documented positive hormone receptor status (ER +ve and/or PgR + ve) of primary or metastatic tumour tissue
3.Patients with metastatic or locally advanced disease not amenable to therapy with curative intent
4.Histological/cytological confirmation of breast cancer
5.Provision of written informed consent

1.postmenopausa
2.recettori ormonali positivi
3.malattia in fase avanzata o localmente avanzata
4.conferma istologica o citologica di carcinoma della mammella
5.consenso informato

E.4

Principal exclusion criteria

1.Previous systemic therapy for advanced breast cancer.
2.Platelets < 100 ´ 109 / L
3.Total bilirubin > 1.5 ´ ULRR (Upper limit of reference range)
4.ALT or AST transamminase > 2.5 ´ ULRR if no demonstrable liver metastases or > 5 ´ ULRR in presence of liver metastases

1.Precedente terapia sistemica per malattia in fase avanzata
2.Piastrine < 100 x 109 / L
3.Bilirubina totale > 1.5 volte i massimi livelli normali
4.Transaminasi ALT or AST > 2.5 volte i massimi livelli normali in assenza di metastasi epatiche o ≥ 5 volte i massimi livelli normali in presenza di metastasi epatiche

E.5 End points

E.5.1

Primary end point(s)

Clinical Benefit will be obtained for those patients who have a best responese (as defined by Recist) of either, CR; PR, or SD #8805; 24 weeks as defined by the modified RECIST Criteria

Beneficio Clinico = Risposta Completa (CR) + Risposta Parziale (PR) + Stabilita' di Malattia (SD) ³ 24 settimane come definito dai criteri RECIST

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

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

Information not present in EudraCT

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

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	No
F.1.1	Number of subjects for this age range:	0
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	No
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	No
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	No
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	20
F.4.2	For a multinational trial
F.4.2.1	In the EEA	120
F.4.2.2	In the whole clinical trial	200

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

2006-07-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2006-05-11

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-10-27

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