Clinical Trials Register

Summary
EudraCT Number:	2011-006326-24
Sponsor's Protocol Code Number:	D699BC00001
National Competent Authority:	Slovakia - SIDC (Slovak)
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-07-30
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

Slovakia - SIDC (Slovak)

A.2

EudraCT number

2011-006326-24

A.3

Full title of the trial

A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg with Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment for Postmenopausal Women with Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated Wuith Any Hormonal Therapy (FALCON)

Randomizované, dvojito zaslepené, multicentrické skúšanie III. fázy v súbežných skupinách pre porovnanie účinnosti a znášanlivosti fulvestrantu (FASLODEX™) v dávke 500 mg s anastrozolom (ARIMIDEX™) v dávke 1 mg ako hormonálnej liečby pre postmenopauzálne ženy s lokálne pokročilým alebo metastatickým karcinómom prsníka pozitívnym na hormonálne receptory, ktoré sa doteraz neliečili žiadnou hormonálnou terapiou

A.3.1

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

A global study to compare the effects of fulvestrant and arimidex in a subset of patients with breast cancer

Globálne klinické skúšanie porovnávajúce účinok fulvestrantu a arimidexu v podskupine pacientok s karcinómom prsníka

A.3.2

Name or abbreviated title of the trial where available

FALCON

A.4.1

Sponsor's protocol code number

D699BC00001

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 AB
B.1.3.4	Country	Sweden
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 AB
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	Clinical Study Information Center
B.5.3	Address:
B.5.3.1	Street Address	Not applicable
B.5.3.2	Town/ city	Not applicable
B.5.3.3	Post code	Not applicable
B.5.3.4	Country	United States
B.5.6	E-mail	Information.Center@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	Yes
D.2.1.1.1	Trade name	Faslodex 250 mg solution for injection
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca UK Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Faslodex 250 mg solution for injection
D.3.2	Product code	ZD9238
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.3.9.1	CAS number	129453-61-8
D.3.9.2	Current sponsor code	ZD9238
D.3.9.3	Other descriptive name	ICI 182780
D.3.9.4	EV Substance Code	SUB13933MIG
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: 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 1 mg film coated tablet
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca UK Limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Arimidex 1 mg film coated tablet
D.3.2	Product code	ZD1033
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	anastrozole
D.3.9.1	CAS number	120511-73-1
D.3.9.2	Current sponsor code	ZD1033
D.3.9.3	Other descriptive name	ANASTROZOLE
D.3.9.4	EV Substance Code	SUB05502MIG
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	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	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	Solution for injection
D.8.4	Route of administration of the placebo	Intramuscular use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
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

hormone receptor positive breast cancer, hormone naive, breast, cancer, neoplasm breast cancer, metastatic, tumour, neoplasm

E.1.1.1

Medical condition in easily understood language

hormone receptor positive breast cancer, hormone naive, breast, cancer, neoplasm, metastatic, tumour

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

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 demonstrate superior progression free survival for patients treated with fulvestrant 500mg versus patients treated with anastrozole 1mg

E.2.2

Secondary objectives of the trial

To compare the overall survival, objective responses, clinical benefit responses, quality of life and safety profile for study patients

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1 Histological confirmation of breast cancer in post menopausal women (age >=60)
2 Positive hormone receptor status (ER +ve and/or PgR +ve) of primary or metastatic tumour tissue based on local laboratory assessment.
3 EITHER locally advanced disease (1 line of chemotherapy allowed only if remain unsuitable for therapy of curative intent) OR Metastatic disease. (1 line of chemotherapy for breast cancer allowed only if subsequent evidence of further progressive disease)
4 At least 1 lesion (measurable and/or non-measurable) that can be accurately assessed at baseline and is suitable for repeated assessment.
5 Postmenopausal woman, fulfilling 1 of: Prior bilateral oophorectomy/Age ≥60 years/Age <60 years and amenorrheic for 12+months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and FSH and oestradiol in the postmenopausal range

E.4

Principal exclusion criteria

1 Presence of life-threatening metastatic disease - Any of: Extensive hepatic involvement/ involving brain or meninges/ symptomatic pulmonary lymph spread. Discrete lung metastases are acceptable if respiratory function is not significantly compromised
2 Prior systemic therapy for breast cancer other than one line of cytotoxic chemotherapy (the last dose of chemotherapy must have been received more than 28 days prior to randomisation).
3 Radiation therapy if not completed within 28 days prior to randomisation (with the exception of radiotherapy given for control of bone pain, started prior to randomisation).
4 Prior hormonal treatment for breast cancer.
5 Current or prior malignancy within previous 3 years (other than breast cancer or adequately treated basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix).

E.5 End points

E.5.1

Primary end point(s)

Compare the progression free survival (PFS) in patients treated with fulvestrant with those treated with anastrozole

E.5.1.1

Timepoint(s) of evaluation of this end point

Baseline RECIST 1.1 assessments and then every 12 weeks until the earliest of disease progression evident, patient dies or has surgery/radiotherapy for their disease.

E.5.2

Secondary end point(s)

1 Compare the Overall Survival (OS, death due to any cause) in patients treated with fulvestrant with those treated with anastrozole when 65% of patients are recorded as having died.
2 Measure objective response rate (ORR) for fulvestrant treatment versus anastrozole. (ORR =% of patients recording partial (PR) or complete response (CR)
3 Measure the duration of response (DoR) for fulvestrant treatment versus anastrozole. (DoR = days from PR/CR response to objective disease progression)
4 Measure expected duration of response (EDoR) for fulvestrant treatment versus anastrozole. (EDoR = p Efp(x), where x=DoR, p=proportion of responders, Efp(x) is mean duration of response)
5 Measure clinical benefit rate (CBR) for fulvestrant treatment versus anastrozole. (CBR= proportion of patients recording RECIST assessments of CR/PR or stable disease (SD) over at least 154 days
6 Measure the duration of clinical benefit (DoCB) for fulvestrant versus anastrozole treatment. (DoCB = for patients recording clinical benefit responses only; days from randomization to date of disease progression)
7 Measure expected duration of clinical benefit (EDoCB) for fulvestrant treatment versus anastrozole. (EDoCB = p Efp(x), where x=DoCB, p=proportion of responders, Efp(x) is mean duration of clinical benefit)
8 Compare the effect of fulvestrant treatment versus anastrozole treatment on Health Related Quality of Life (HRQoL)
9 Compare the safety of fulvestrant treatment versus anastrozole by assessing a panel of adverse events measures: physical examination, electrocardiogram, pulse and blood pressure, weight and haematology and clinical chemistry assessments

E.5.2.1

Timepoint(s) of evaluation of this end point

1 Following progression, patients will be contacted at 12 weekly intervals to determine survival status

Nos 2-7 Baseline RECIST 1.1 assessments and then every 12 weeks

8 Quality of life questionnaires completed at baseline, 12 weekly whilst on treatment, or 24 weekly for patients being followed for survival

9 Up to the primary analysis: Adverse event will be collected from consent to 56 days after final injection. Vital signs will be collected at each on-treatment visit; ECGs, clinical chemistry and haematology collected from randomization and every 12 weeks until 35 days after final injection. Following the primary analysis, only serious adverse events are recorded.

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)

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)

Yes

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

Yes

E.8.4

The trial involves multiple sites in the 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

Argentina

Peru

Ukraine

Taiwan

Brazil

Canada

China

Japan

Mexico

Russian Federation

South Africa

United Kingdom

United States

Czechia

Italy

Poland

Slovakia

Spain

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 study database will close after the last patient assessment/visit contributing to the overall survival analysis, which will be conducted when approximately 50% patients have died. The end of the study is defined as the last visit of the last patient, occurring when the last patient has discontinued study therapy

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:

225

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

225

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

119

F.4.2.2

In the whole clinical trial

450

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 continue to receive study treatment beyond the closure of the database if, in the opinion of the investigator, they are continuing to receive benefit from treatment with fulvestrant or anastrozole and cannot access appropriate treatment outside of the clinical study protocol.

Pacientky budú môcť aj po uzavretí databázy ďalej dostávať odslepenú účinnú liečbu (buď fulvestrant alebo anastrozol) ak bude podľa názoru skúšajúceho prinášať pacientkam prospech a nebudú mať prístup k vhodnej terapii mimo protokolu skúšania.

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

2012-07-31

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-06-14

P. End of Trial
P.	End of Trial Status	Completed

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