Clinical trial NCT00256698: Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy
Official title: FACT: Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy; an Open Randomized, Comparative, Phase III Multicentre Study in Postmenopausal Women With Hormone Receptor Positive Breast Cancer in First Relapse After Primary Treatment of Localized Tumor.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Hormone
receptor
positive
breast
cancer
first
relapse
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-22
Enrollment: 514
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive women with first relapse of breast cancer.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent, postmenopausal females, histological or cytological confirmed oestrogene and/or progesterone (PgR) receptor positive breast cancer, local recurrence or metastasis

Exclusion Criteria:

* Previous systemic endocrine therapy for advanced or recurrent disease; prior fulvestrant therapy
* Premenopausal women

Primary outcomes:
measure: Time to Progression (TTP)
timeFrame: RECIST assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
Secondary outcomes:
measure: Percentage of Evaluable Participants With Objective Response Rate (ORR)
timeFrame: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
measure: Percentage of Clinical Benefit Rate (CBR) Responders
timeFrame: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
measure: Duration of Response (DoR)
timeFrame: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
measure: Duration of Clinical Benefit (DoCB)
timeFrame: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
measure: Time to Treatment Failure (TTF)
timeFrame: From randomisation until data cut-off on 30th April 2009
measure: Overall Survival (OS)
timeFrame: All deaths occurring between randomisation and data cut-off on 30th April 2009 are included.
Other outcomes:
Locations:
city: Brampton
country: Canada
facility: Research Site
city: Halifax
country: Canada
facility: Research Site
city: Kingston
country: Canada
facility: Research Site
city: Ontario
country: Canada
facility: Research Site
city: Toronto
country: Canada
facility: Research Site
city: San Jose
country: Costa Rica
facility: Research Site
city: Hameenlinna
country: Finland
facility: Research Site
city: Turku
country: Finland
facility: Research Site
city: Avignon
country: France
facility: Research Site
city: Caen
country: France
facility: Research Site
city: Creteil
country: France
facility: Research Site
city: Grenoble
country: France
facility: Research Site
city: La Chaussee Saint Victor
country: France
facility: Research Site
city: Perigueux
country: France
facility: Research Site
city: Perpignan
country: France
facility: Research Site
city: Saint Cyr Sur Louire
country: France
facility: Research Site
city: Toulouse
country: France
facility: Research Site
city: Augsburg
country: Germany
facility: Research Site
city: Dusseldorf
country: Germany
facility: Research Site
city: Erlangen
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Gifhorn
country: Germany
facility: Research Site
city: Grosshadern
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Ingolstadt
country: Germany
facility: Research Site
city: Kassel
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Koln
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Leverkusen
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: Marburg
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Rostock
country: Germany
facility: Research Site
city: Trier
country: Germany
facility: Research Site
city: Ulm
country: Germany
facility: Research Site
city: Ziwicken
country: Germany
facility: Research Site
city: Guatemala
country: Guatemala
facility: Research Site
city: Reykjavik
country: Iceland
facility: Research Site
city: Como
country: Italy
facility: Research Site
city: Fabriano
country: Italy
facility: Research Site
city: Ferrara
country: Italy
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Lugo
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Taormina
country: Italy
facility: Research Site
city: Treviglio
country: Italy
facility: Research Site
city: Vicenza
country: Italy
facility: Research Site
city: Drammen
country: Norway
facility: Research Site
city: Ilesund
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Porsgrunn
country: Norway
facility: Research Site
city: Stavanger
country: Norway
facility: Research Site
city: Troms
country: Norway
facility: Research Site
city: Trondheim
country: Norway
facility: Research Site
city: Cascais
country: Portugal
facility: Research Site
city: Coimbra
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Santa Maria da Feira
country: Portugal
facility: Research Site
city: Halmstad
country: Sweden
facility: Research Site
city: Helsingborg
country: Sweden
facility: Research Site
city: Kalmar
country: Sweden
facility: Research Site
city: Karlskrona
country: Sweden
facility: Research Site
city: Kristianstad
country: Sweden
facility: Research Site
city: Link'ping
country: Sweden
facility: Research Site
city: M'lndal
country: Sweden
facility: Research Site
city: Malm
country: Sweden
facility: Research Site
city: Norrk'ping
country: Sweden
facility: Research Site
city: Skelleftea
country: Sweden
facility: Research Site
city: Skovde
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Sunderbyn
country: Sweden
facility: Research Site
city: Sundsvall
country: Sweden
facility: Research Site
city: Umea
country: Sweden
facility: Research Site
city: V'rnamo
country: Sweden
facility: Research Site
city: V'stervik
country: Sweden
facility: Research Site
city: Varberg
country: Sweden
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Edirne
country: Turkey
facility: Research Site
city: Gaziantep
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Roger Henriksson, MD
role: STUDY_DIRECTOR
References: