Effectiveness of Combination of Arimidex and Nolvadex in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women.

Condition(s) targeted: Breast Cancer

Intervention: Anastrozole (Drug); Tamoxifen (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Manfred Kaufmann, MD, Principal Investigator, Affiliation: German Adjuvant Breast Cancer Group

The purpose of this study is to determine the efficacy and tolerability of 3 years treatment with anastrozole after a prior 2 years' treatment with tamoxifen versus 5 years treatment with tamoxifen in postmenopausal women with early breast cancer

Official title: A Prospective, Multi-Centre, Randomised, Open Parallel Group Study to Compare the Effectiveness and Compatibility of ARIMIDEX (ZD 1033) With NOLVADEX After a Prior 2 Years' Treatment With Tamoxifen in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women.

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

Primary outcome: To assess the difference in disease-free survival between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen

Secondary outcome:

To assess difference in overall survival between the two treatment arms

To assess difference in disease recurrence between the two treatment arms

To assess difference in safety and tolerability between the two treatment arms

Minimum age: N/A. Maximum age: 75 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Signed informed consent,

- Post-menopausal women ≤75 years,

- histologically confirmed invasive breast carcinoma (no distant metastases),

- positive hormone receptor status,

- continuous 2-year adjuvant tamoxifen therapy 20 mg/30 mg with 4 weeks after primary

surgery

Exclusion Criteria:

- menopause status maintained by medication,

- pre-operative chemotherapy or hormone therapy or radiation therapy,

- relapse or second carcinoma or previous cancerous disease,

- breast carcinoma in situ,

- simultaneous carcinoma of the opposite side or secondary breast,

- 10 or more tumour-infiltrated lymph nodes.

- serious accompanying diseases

Research Site, Albstadt, Germany

Research Site, Berlin, Germany

Research Site, Cloppenburg, Germany

Research Site, Eggenfelden, Germany

Research Site, Frankfurt, Germany

Research Site, Freiburg, Germany

Research Site, Goettingen, Germany

Research Site, Halle, Germany

Research Site, Hamburg, Germany

Research Site, Hanau, Germany

Research Site, Hannover, Germany

Research Site, Heidelberg, Germany

Research Site, Hoyerswerda, Germany

Research Site, Idar-Oberstein, Germany

Research Site, Jena, Germany

Research Site, Karlsruhe, Germany

Research Site, Kassel, Germany

Research Site, Kiel, Germany

Research Site, Leonberg, Germany

Research Site, Lingen, Germany

Research Site, Luebeck, Germany

Research Site, Magdeburg, Germany

Research Site, Mainz, Germany

Research Site, Mannheim, Germany

Research Site, Muenchen, Germany

Research Site, Muenster, Germany

Research Site, Neustadt, Germany

Research Site, Osnabrueck, Germany

Research Site, Paderborn, Germany

Research Site, Pforzheim, Germany

Research Site, Recklinghausen, Germany

Research Site, Rosenheim, Germany

Research Site, Rostock, Germany

Research Site, Ruesselsheim, Germany

Research Site, Schleswig, Germany

Research Site, Siegen, Germany

Research Site, Titisee-Neustadt, Germany

Research Site, Tuebingen, Germany

Research Site, Ulm, Germany

Research Site, Waiblingen, Germany

Research Site, Westerstede, Germany

Research Site, Worms, Germany

Research Site, Wuerzburg, Germany

Starting date: November 1996
Ending date: December 2007
Last updated: December 14, 2007