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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Anastrozole; Drug: Tamoxifen

• Registration Number: NCT00287534
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 1996-11
• Study Completion: 2004-09
• Study First Submitted: 2006-02-06
• Study First Submitted QC: 2006-02-06
• Study First Posted: 2006-02-07
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-07
• Last Update Posted: 2009-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1059

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Anastrozole	Anastrozole
2	Tamoxifen	Tamoxifen

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇩🇪 Wuerzburg, Germany