ITA - Clinical Study Comparing ARIMIDEX™ With NOLVADEX™ in Women With Breast Cancer Treated With NOLVADEX for at Least 2 Years

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study was 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 on tamoxifen.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Institute of Cancer Research, United Kingdom
• Treatments: Anastrozole; Tamoxifen

Criteria

Inclusion Criteria:

• Post-menopausal status; age ≤75 years;

• histologically confirmed invasive breast cancer with metastases in the axillary lymph nodes;

• oestrogen receptor status positive or unknown;

• primary treatment (surgery +/- radiotherapy, +/- chemotherapy) completed

Exclusion Criteria:

• Clinical evidence of metastatic disease (including local or remote recurrence, even if the patient appeared to be in complete remission at the time of randomisation).