ABCSG 8 - Adjuvant Treatment in Patients With Hormone Receptor-Positive Breast Cancer With Good to Moderate Differentiation.

Condition(s) targeted: Breast Cancer

Intervention: Tamoxifen (Drug); Anastrozole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Raimund Jakesz, MD, Principal Investigator, Affiliation: Austrian Breast and Colorectal Cancer Study Group
AstraZeneca Austria Medical Director, MD, Study Director, Affiliation: AstraZeneca

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.

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

Primary outcome: 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 outcome: 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.

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

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

Research Sites, Vienna, Austria

Research Site, Oberpullendorf, Austria

Research Site, Oberwart, Austria

Research Site, Guessing, Austria

Research Site, Eisenstadt, Austria

Research Site, Klagenfurt, Austria

Research Site, St. Veit/Glan, Austria

Research Site, Wolfsberg, Austria

Research Site, Villach, Austria

Research Site, Spittal/Drau, Austria

Research Site, St. Poelton, Austria

Research Site, Tulln, Austria

Research Site, Horn, Austria

Research Site, Neunkirchen, Austria

Research Site, Hollabrunn, Austria

Research Site, Amstetten, Austria

Research Site, Waidhofen/Thaya, Austria

Research Sites, Linz, Austria

Research Site, Wels, Austria

Research Site, Schaerding, Austria

Research Site, Kirchdorf, Austria

Research Site, Voecklabruck, Austria

Research Site, Salzburg, Austria

Research Site, Schwarzach/Pongau, Austria

Research Sites, Graz, Austria

Research Site, Judenburg, Austria

Research Site, Leoben, Austria

Research Site, Schladming, Austria

Research Site, Fuerstenfeld, Austria

Research Site, Zams, Austria

Research Site, Kufstein, Austria

Research Site, Innsbruck, Austria

Research Site, Feldkirch, Austria

Research Site, Dornbirn, Austria

Research Site, Bregenz, Austria

Research Site, Rohrbach, Austria

Research Site, Moedling, Austria

Research Site, Steyr, Austria

Research Site, Mistelbach, Austria

Research Site, Ried im Innkreis, Austria

Research Site, Baden, Austria

Research Site, Bruck/Mur, Austria

Research Site, Hartberg, Austria

Research Site, Feldbach, Austria

Research Site, Hainburg, Austria

Research SIte, Melk, Austria

Research Sites, Klosterneuburg, Austria

Research Site, Bad Ischl, Austria

Research Site, Gmuend, Austria

Research Site, Scheibbs, Austria

Research Site, Rottenmann, Austria

Research Site, Freistadt, Austria

Starting date: January 1996
Last updated: February 8, 2007