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

Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291759
• Other study ID #: 1033AU/0002
• Secondary ID: ABCSG 8
• Status: Completed
• Phase: Phase 3
• First received: February 13, 2006
• Last updated: January 29, 2013
• Start date: January 1996
• Est. completion date: June 2009

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3858
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• Tamoxifen

• Anastrozole

Locations

Country	Name	City	State
Austria	Research Site	Amstetten
Austria	Research Site	Bad Ischl
Austria	Research Site	Baden
Austria	Research Site	Bregenz
Austria	Research Site	Bruck/Mur
Austria	Research Site	Dornbirn
Austria	Research Site	Eisenstadt
Austria	Research Site	Feldbach
Austria	Research Site	Feldkirch
Austria	Research Site	Freistadt
Austria	Research Site	Fuerstenfeld
Austria	Research Site	Gmuend
Austria	Research Sites	Graz
Austria	Research Site	Guessing
Austria	Research Site	Hainburg
Austria	Research Site	Hartberg
Austria	Research Site	Hollabrunn
Austria	Research Site	Horn
Austria	Research Site	Innsbruck
Austria	Research Site	Judenburg
Austria	Research Site	Kirchdorf
Austria	Research Site	Klagenfurt
Austria	Research Sites	Klosterneuburg
Austria	Research Site	Kufstein
Austria	Research Site	Leoben
Austria	Research Sites	Linz
Austria	Research SIte	Melk
Austria	Research Site	Mistelbach
Austria	Research Site	Moedling
Austria	Research Site	Neunkirchen
Austria	Research Site	Oberpullendorf
Austria	Research Site	Oberwart
Austria	Research Site	Ried im Innkreis
Austria	Research Site	Rohrbach
Austria	Research Site	Rottenmann
Austria	Research Site	Salzburg
Austria	Research Site	Schaerding
Austria	Research Site	Scheibbs
Austria	Research Site	Schladming
Austria	Research Site	Schwarzach/Pongau
Austria	Research Site	Spittal/Drau
Austria	Research Site	St. Poelton
Austria	Research Site	St. Veit/Glan
Austria	Research Site	Steyr
Austria	Research Site	Tulln
Austria	Research Sites	Vienna
Austria	Research Site	Villach
Austria	Research Site	Voecklabruck
Austria	Research Site	Waidhofen/Thaya
Austria	Research Site	Wels
Austria	Research Site	Wolfsberg
Austria	Research Site	Zams

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.