ITA - Clinical Study Comparing ARIMIDEX™ With NOLVADEX™ in Women With Breast Cancer Treated With NOLVADEX for at Least 2 Years
- Registration Number
- NCT00286117
- Lead Sponsor
- AstraZeneca
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 448
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).
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 The primary objective of this analysis 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
- Secondary Outcome Measures
Name Time Method Assess the difference in overall survival/disease recurrence/safety and tolerability between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen.
Trial Locations
- Locations (1)
Research Site
🇮🇹Vicenza, Italy