3 Years of Anastrozole vs. no Treatment as Extended Adjuvant Therapy for Postmenopausal Women With Breast Cancer

Condition(s) targeted: Breast Neoplasms

Intervention: Anastrozole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Austria Medical Director, MD, Study Director, Affiliation: AstraZeneca

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.

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 design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Recurrence-free and overall survival

Secondary outcome: Secondary cancers

Minimum age: N/A. Maximum age: 80 Years. Gender(s): Female.

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

Research Site, Graz, Austria

Research Site, Horn, Austria

Research Site, Linz, Austria

Research Site, Wels, Austria

Research Site, Wien, Austria

Research Site, Zams, Austria

Research Site, Baden, Austria

Research Site, Krems, Austria

Research Site, Steyr, Austria

Research Site, Tulln, Austria

Research Site, Leoben, Austria

Research Site, Bregenz, Austria

Research Site, Villach, Austria

Research Site, Dornbirn, Austria

Research Site, Feldbach, Austria

Research Site, Guessing, Austria

Research Site, Hainburg, Austria

Research Site, Hartberg, Austria

Research Site, Kufstein, Austria

Research Site, Moedling, Austria

Research Site, Oberwart, Austria

Research Site, Rohrbach, Austria

Research Site, Salzburg, Austria

Research Site, Scheibbs, Austria

Research Site, Amstetten, Austria

Research Site, Bad Ischl, Austria

Research Site, Feldkirch, Austria

Research Site, Freistadt, Austria

Research Site, Innsbruck, Austria

Research Site, Kirchdorf, Austria

Research Site, Wolfsberg, Austria

Research Site, Eisenstadt, Austria

Research site, Hollabrunn, Austria

Research Site, Klagenfurt, Austria

Research Site, Mistelbach, Austria

Research Site, Rottenmann, Austria

Research Site, Schaerding, Austria

Research Site, Schladming, Austria

Research Site, Schwarzach, Austria

Research Site, Neunkirche, Austria

Research Site, St. Poelten, Austria

Research Site, Fuerstenfeld, Austria

Research Site, Sankt Pölten, Austria

Research Site, Klosterneuburg, Austria

Research Site, Oberpullendorf, Austria

Research Site, Wiener Neustadt, Austria

Research Site, Bruck an der Mur, Austria

Research Site, Ried im Innkreis, Austria

Research Site, Spittal an der Drau, Austria

Research Site, St. Veit an der Glan, Austria

Research Site, Waidhofen an der Ybbs, Austria

Research Site, Voecklabruck, Austria

AstraZeneca Clinical Study Information

Starting date: December 1995
Last updated: February 8, 2007