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

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: German Adjuvant Breast Cancer Group
• Treatments: Anastrozole; Tamoxifen

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