Clinical trial NCT00291759: ABCSG 8 - Adjuvant Treatment in Patients With Hormone Receptor-positive Breast Cancer With Good to Moderate Differentiation.
Official title: Adjuvant Endocrine Therapy in Postmenopausal Patients With HR +ve BC With Good to Moderate Differentiation - ARNO (Arimidex + Nolvadex). Primary Treatment for 2 Years With Tamoxifen Thereafter Randomisation to: Tamoxifen 3 Years or Anastrozole 3 Years.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-02-15
Enrollment: 3858
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 purpose of this study is to assess the difference in event-free survival between postmenopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen.


Eligibility criteria: Inclusion Criteria:

* Invasive mammary carcinoma after radical treatment, without prior chemo/hormone/radiation therapy.
* At least 6 lymph nodes examined.
* Good or intermediate tumour differentiation.
* \<6 weeks before start of adjuvant therapy.
* Oestrogen or Progesterone positive

Exclusion Criteria:

* Premenopausal.
* Preoperative hormonal/antihormonal/radiation/cytoxic chemo. Second malignant tumour/status post second malignant tumour.
* In-situ/T4 carcinoma.
* Age \>80 years.
* World Health Organisation performance index \>3.
* Serious accompanying diseases

Primary outcomes:
measure: To assess the difference in event free survival and overall survival (subject to stand-alone or combined/meta-analysis) between postmenopausal women with HR +ve early BC who switched from tamoxifen to anastrozole and those who continued on tamoxifen.
Secondary outcomes:
measure: To assess the difference in event free survival & overall survival (subject to stand-alone or combined/meta-analysis) plus side effects between postmenopausal women with HR+ve early BC who switched from tam to anastrozole and those who continued on tam.
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/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: Gmuend
country: Austria
facility: Research Site
city: Graz
country: Austria
facility: Research Sites
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: Judenburg
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 Sites
city: Kufstein
country: Austria
facility: Research Site
city: Leoben
country: Austria
facility: Research Site
city: Linz
country: Austria
facility: Research Sites
city: Melk
country: Austria
facility: Research SIte
city: Mistelbach
country: Austria
facility: Research Site
city: Moedling
country: Austria
facility: Research Site
city: Neunkirchen
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: Schaerding
country: Austria
facility: Research Site
city: Scheibbs
country: Austria
facility: Research Site
city: Schladming
country: Austria
facility: Research Site
city: Schwarzach/Pongau
country: Austria
facility: Research Site
city: Spittal/Drau
country: Austria
facility: Research Site
city: St. Poelton
country: Austria
facility: Research Site
city: St. Veit/Glan
country: Austria
facility: Research Site
city: Steyr
country: Austria
facility: Research Site
city: Tulln
country: Austria
facility: Research Site
city: Vienna
country: Austria
facility: Research Sites
city: Villach
country: Austria
facility: Research Site
city: Voecklabruck
country: Austria
facility: Research Site
city: Waidhofen/Thaya
country: Austria
facility: Research Site
city: Wels
country: Austria
facility: Research Site
city: Wolfsberg
country: Austria
facility: Research Site
city: Zams
country: Austria
facility: Research Site
Study officials:
affiliation: Austrian Breast and Colorectal Cancer Study Group
name: Raimund Jakesz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: AstraZeneca Austria Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: Sestak I, Cuzick J, Dowsett M, Lopez-Knowles E, Filipits M, Dubsky P, Cowens JW, Ferree S, Schaper C, Fesl C, Gnant M. Prediction of late distant recurrence after 5 years of endocrine treatment: a combined analysis of patients from the Austrian breast and colorectal cancer study group 8 and arimidex, tamoxifen alone or in combination randomized trials using the PAM50 risk of recurrence score. J Clin Oncol. 2015 Mar 10;33(8):916-22. doi: 10.1200/JCO.2014.55.6894. Epub 2014 Oct 20.
citation: Gnant M, Filipits M, Greil R, Stoeger H, Rudas M, Bago-Horvath Z, Mlineritsch B, Kwasny W, Knauer M, Singer C, Jakesz R, Dubsky P, Fitzal F, Bartsch R, Steger G, Balic M, Ressler S, Cowens JW, Storhoff J, Ferree S, Schaper C, Liu S, Fesl C, Nielsen TO; Austrian Breast and Colorectal Cancer Study Group. Predicting distant recurrence in receptor-positive breast cancer patients with limited clinicopathological risk: using the PAM50 Risk of Recurrence score in 1478 postmenopausal patients of the ABCSG-8 trial treated with adjuvant endocrine therapy alone. Ann Oncol. 2014 Feb;25(2):339-45. doi: 10.1093/annonc/mdt494. Epub 2013 Dec 16.