Secondary Adjuvant Long Term Study With Arimidex

Condition(s) targeted: Breast Cancer

Intervention: Anastrozole (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: AstraZeneca

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

Overall contact:
AstraZeneca Austria Medical Information, Phone: +43 (1) 711 31 0

The study assesses the effect of a further 2 years vs a further 5 years of adjuvant treatment with anastrozole after initial 5 years of adjuvant endocrine therapy.

Official title: A Prospective, Randomized, Open, Multicentre Phase III-Study to Assess the Efficacy of Secondary Adjuvant Endocrine Anastrozole Therapy for 2 Further Yrs vs 5 Further Yrs in Patients With HR +ve Breast Cancer After 5-yr Primary Adjuvant Endocrine Therapy

Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Assessment of the effect in terms of DFS of 2 further years of anastrozole treatment vs further 5 years of adjuvant anastrozole treatment, following 5 years of adjuvant endocrine treatment

Secondary outcome: Assessment of overall survival rate, rate of fracture occurrence, occurrence of secondary carcinoma and contralateral breast cancer in the two treatment groups

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

AstraZeneca Austria Medical Information, Phone: +43 (1) 711 31 0

Research Site, Wien, Austria; Terminated

Research Site, Oberpullendorf, Austria; Recruiting

Research Site, Oberwart, Austria; Recruiting

Research Site, Güssing, Austria; Recruiting

Research Site, Eisenstadt, Austria; Recruiting

Research Site, Klagenfurt, Austria; Recruiting

Research Site, St. Veit / Glan, Austria; Recruiting

Research Site, Wolfsberg, Austria; Recruiting

Research Site, Villach, Austria; Recruiting

Research Site, Wr. Neustadt, Austria; Recruiting

Research Site, Amstetten, Austria; Recruiting

Research Site, Waidhofen / Thaya, Austria; Recruiting

Research Site, Linz, Austria; Recruiting

Research Site, Wels, Austria; Recruiting

Research Site, Kirchdorf / Krems, Austria; Recruiting

Research Site, Vöcklabruck, Austria; Recruiting

Research Site, Salzburg, Austria; Recruiting

Research Site, Schwarzach / Pongau, Austria; Recruiting

Research Site, Graz, Austria; Recruiting

Research Site, Leoben, Austria; Recruiting

Research Site, Fürstenfeld, Austria; Recruiting

Research Site, Innsbruck, Austria; Recruiting

Research Site, Zams, Austria; Recruiting

Research Site, Hall / Tirol, Austria; Recruiting

Research Site, Kufstein, Austria; Recruiting

Research Site, Lienz, Austria; Recruiting

Research SIte, Feldkirch, Austria; Recruiting

Research Site, Dornbirn, Austria; Recruiting

Research Site, Mödling, Austria; Recruiting

Research Site, St. Pölten, Austria; Recruiting

Research Site, Steyr, Austria; Recruiting

Research Site, Krems, Austria; Recruiting

Research Site, Mistelbach, Austria; Recruiting

Research Site, Ried / Innkreis, Austria; Recruiting

Research Site, Baden, Austria; Recruiting

Research Site, Feldbach, Austria; Recruiting

Research Site, Melk, Austria; Recruiting

Research Site, Bad Ischl, Austria; Recruiting

Research Site, Neunkirchen, Austria; Recruiting

Research Site, Scheibbs, Austria; Recruiting

Research Site, Rottenmann, Austria; Recruiting

Research Site, Freistadt, Austria; Recruiting

Research Site, Gmunden, Austria; Recruiting

Research Site, Bregenz, Austria; Recruiting

Research Site, Judenburg, Austria; Recruiting

Research Site, Vienna, Austria; Recruiting

Starting date: March 2004
Ending date: January 2019
Last updated: April 30, 2009