Clinical trial NCT00300508: 3 Years of Anastrozole vs. no Treatment as Extended Adjuvant Therapy for Postmenopausal Women With Breast Cancer
Official title: A Randomized, Open, Comparative Multicentre Trial of 3 Years Anastrozole Treatment vs. 3 Years no Treatment in Postmenopausal Patients With Breast Cancer Who Have Completed 5 Years Adjuvant Hormone Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Neoplasms
Keywords: Hormone receptor positive breast cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-03-09
Enrollment: 856
Sex: FEMALE
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study assesses the effect of a further 3 years adjuvant treatment with anastrozole vs. an untreated control group after initial 5 years of adjuvant hormone-therapy.


Eligibility criteria: Inclusion Criteria:

* No disease recurrence at time of randomization,
* patients with breast cancer after surgery,
* 5 years (+/- 12 months) of prior endocrine therapy

Exclusion Criteria:

* Premenopausal patients,
* unknown or negative receptor status,
* Secondary malignant tumor

Primary outcomes:
measure: Recurrence-free and overall survival
Secondary outcomes:
measure: Secondary cancers
Other outcomes:
Locations:
city: Amstetten
country: Austria
facility: Research Site
city: Bad Ischl
country: Austria
facility: Research Site
city: Baden
country: Austria
facility: Research Site
city: Bregenz
country: Austria
facility: Research Site
city: Bruck an der Mur
country: Austria
facility: Research Site
city: Dornbirn
country: Austria
facility: Research Site
city: Eisenstadt
country: Austria
facility: Research Site
city: Feldbach
country: Austria
facility: Research Site
city: Feldkirch
country: Austria
facility: Research Site
city: Freistadt
country: Austria
facility: Research Site
city: Fuerstenfeld
country: Austria
facility: Research Site
city: Graz
country: Austria
facility: Research Site
city: Guessing
country: Austria
facility: Research Site
city: Hainburg
country: Austria
facility: Research Site
city: Hartberg
country: Austria
facility: Research Site
city: Hollabrunn
country: Austria
facility: Research site
city: Horn
country: Austria
facility: Research Site
city: Innsbruck
country: Austria
facility: Research Site
city: Kirchdorf
country: Austria
facility: Research Site
city: Klagenfurt
country: Austria
facility: Research Site
city: Klosterneuburg
country: Austria
facility: Research Site
city: Krems
country: Austria
facility: Research Site
city: Kufstein
country: Austria
facility: Research Site
city: Leoben
country: Austria
facility: Research Site
city: Linz
country: Austria
facility: Research Site
city: Mistelbach
country: Austria
facility: Research Site
city: Moedling
country: Austria
facility: Research Site
city: Neunkirche
country: Austria
facility: Research Site
city: Oberpullendorf
country: Austria
facility: Research Site
city: Oberwart
country: Austria
facility: Research Site
city: Ried im Innkreis
country: Austria
facility: Research Site
city: Rohrbach
country: Austria
facility: Research Site
city: Rottenmann
country: Austria
facility: Research Site
city: Salzburg
country: Austria
facility: Research Site
city: Sankt Pölten
country: Austria
facility: Research Site
city: Schaerding
country: Austria
facility: Research Site
city: Scheibbs
country: Austria
facility: Research Site
city: Schladming
country: Austria
facility: Research Site
city: Schwarzach
country: Austria
facility: Research Site
city: Spittal an der Drau
country: Austria
facility: Research Site
city: St. Poelten
country: Austria
facility: Research Site
city: St. Veit an der Glan
country: Austria
facility: Research Site
city: Steyr
country: Austria
facility: Research Site
city: Tulln
country: Austria
facility: Research Site
city: Villach
country: Austria
facility: Research Site
city: Voecklabruck
country: Austria
facility: Research Site
city: Waidhofen an der Ybbs
country: Austria
facility: Research Site
city: Wels
country: Austria
facility: Research Site
city: Wiener Neustadt
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Wolfsberg
country: Austria
facility: Research Site
city: Zams
country: Austria
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Austria Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: Gnant M, Pfeiler G, Stoger H, Mlineritsch B, Fitzal F, Balic M, Kwasny W, Seifert M, Stierer M, Dubsky P, Greil R, Steger G, Samonigg H, Fesl C, Jakesz R. The predictive impact of body mass index on the efficacy of extended adjuvant endocrine treatment with anastrozole in postmenopausal patients with breast cancer: an analysis of the randomised ABCSG-6a trial. Br J Cancer. 2013 Aug 6;109(3):589-96. doi: 10.1038/bjc.2013.367. Epub 2013 Jul 18.