Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy

Breast Cancer Clinical Trial

— FACT  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00256698
• Other study ID #: D6997L00002
• Secondary ID: 9238SW/0001FACT
• Status: Completed
• Phase: Phase 3
• First received: November 20, 2005
• Last updated: July 27, 2012
• Start date: January 2004
• Est. completion date: February 2012

Study information

• Verified date: July 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 514
• Est. completion date: February 2012
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• Fulvestrant
intramuscular injection 250 mg loading dose (LD) regimen
• Anastrozole
1 mg oral tablet

Locations

Country	Name	City	State
Canada	Research Site	Brampton
Canada	Research Site	Halifax
Canada	Research Site	Kingston
Canada	Research Site	Ontario
Canada	Research Site	Toronto
Costa Rica	Research Site	San Jose
Finland	Research Site	Hameenlinna
Finland	Research Site	Turku
France	Research Site	Avignon
France	Research Site	Caen
France	Research Site	Creteil
France	Research Site	Grenoble
France	Research Site	La Chaussee Saint Victor
France	Research Site	Perigueux
France	Research Site	Perpignan
France	Research Site	Saint Cyr Sur Louire
France	Research Site	Toulouse
Germany	Research Site	Augsburg
Germany	Research Site	Dusseldorf
Germany	Research Site	Erlangen
Germany	Research Site	Frankfurt
Germany	Research Site	Gifhorn
Germany	Research Site	Grosshadern
Germany	Research Site	Halle
Germany	Research Site	Hamburg
Germany	Research Site	Hannover
Germany	Research Site	Heidelberg
Germany	Research Site	Ingolstadt
Germany	Research Site	Kassel
Germany	Research Site	Kiel
Germany	Research Site	Koln
Germany	Research Site	Leipzig
Germany	Research Site	Leverkusen
Germany	Research Site	Magdeburg
Germany	Research Site	Mannheim
Germany	Research Site	Marburg
Germany	Research Site	Munchen
Germany	Research Site	Rostock
Germany	Research Site	Trier
Germany	Research Site	Ulm
Germany	Research Site	Ziwicken
Guatemala	Research Site	Guatemala
Iceland	Research Site	Reykjavik
Italy	Research Site	Como
Italy	Research Site	Fabriano
Italy	Research Site	Ferrara
Italy	Research Site	Firenze
Italy	Research Site	Lugo
Italy	Research Site	Milano
Italy	Research Site	Taormina
Italy	Research Site	Treviglio
Italy	Research Site	Vicenza
Norway	Research Site	Drammen
Norway	Research Site	Ilesund
Norway	Research Site	Oslo
Norway	Research Site	Porsgrunn
Norway	Research Site	Stavanger
Norway	Research Site	Troms
Norway	Research Site	Trondheim
Portugal	Research Site	Cascais
Portugal	Research Site	Coimbra
Portugal	Research Site	Lisboa
Portugal	Research Site	Santa Maria da Feira
Sweden	Research Site	Halmstad
Sweden	Research Site	Helsingborg
Sweden	Research Site	Kalmar
Sweden	Research Site	Karlskrona
Sweden	Research Site	Kristianstad
Sweden	Research Site	Link'ping
Sweden	Research Site	M'lndal
Sweden	Research Site	Malm
Sweden	Research Site	Norrk'ping
Sweden	Research Site	Skelleftea
Sweden	Research Site	Skovde
Sweden	Research Site	Stockholm
Sweden	Research Site	Sunderbyn
Sweden	Research Site	Sundsvall
Sweden	Research Site	Umea
Sweden	Research Site	V'rnamo
Sweden	Research Site	V'stervik
Sweden	Research Site	Varberg
Turkey	Research Site	Ankara
Turkey	Research Site	Edirne
Turkey	Research Site	Gaziantep
Turkey	Research Site	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Canada,  Costa Rica,  Finland,  France,  Germany,  Guatemala,  Iceland,  Italy,  Norway,  Portugal,  Sweden,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Progression (TTP)	RECIST (Response Evaluation Criteria in Solid Tumours) assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009. TTP, time in months to worsen 'progression' according to RECIST criteria. (RECIST is a set of published rules that define when cancer patients improve "respond", stay the same "stable"or worsen "progression" during treatments.	RECIST assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009	No
Secondary	Percentage of Evaluable Participants With Objective Response Rate (ORR)	No. of patients who were objective responders over the no. of patients evaluable for response x100. An objective responder = a patient whose best response is either CR (disappearance of all lesions) or PR (>= 30% shrinkage in the sum of the longest diamemeters of the measurable lesions + no new lesions + no progression of non-measurable lesions)	RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009	No
Secondary	Percentage of Clinical Benefit Rate (CBR) Responders	No. of patients who were clinical benefit responders over the no. of randomised patients x100. A clinical benefit responder = a patient whose best response is CR, PR or SD>=24 weeks (where a best response of SD = no new lesions and for existing lesions; neither suffient shrinkage to count as PR nor sufficient growth to count as progression)	RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009	No
Secondary	Duration of Response (DoR)	Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are objective responders	RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009	No
Secondary	Duration of Clinical Benefit (DoCB)	Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are clinical benefit responders	RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009	No
Secondary	Time to Treatment Failure (TTF)	Time from randomisation until the date of discontinuation of randomised treatment for any reason	From randomisation until data cut-off on 30th April 2009	No
Secondary	Overall Survival (OS)	Overall survival is equivalent to time to death. Time from randomisation until the date of death	All deaths occurring between randomisation and data cut-off on 30th April 2009 are included.	No

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