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.

AstraZeneca1 site in 1 country1,059 target enrollmentNovember 1996

ConditionsBreast Cancer

InterventionsAnastrozole Tamoxifen

DrugsAnastrozole Tamoxifen

Overview

Phase: Phase 2
Intervention: Anastrozole
Conditions: Breast Cancer
Sponsor: AstraZeneca
Enrollment: 1059
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

November 1996

End Date

September 2004

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

AstraZeneca

Eligibility 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

Arms & Interventions

1

Anastrozole

Intervention: Anastrozole

2

Tamoxifen

Intervention: Tamoxifen

Outcomes

Primary Outcomes

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