ABCSG 8 - Adjuvant Treatment in Patients With Hormone Receptor-positive Breast Cancer With Good to Moderate Differentiation.
Phase 3
Completed
- Conditions
- Breast Cancer
- Registration Number
- NCT00291759
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to assess the difference in event-free survival between postmenopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 3858
Inclusion Criteria
- Invasive mammary carcinoma after radical treatment, without prior chemo/hormone/radiation therapy.
- At least 6 lymph nodes examined.
- Good or intermediate tumour differentiation.
- <6 weeks before start of adjuvant therapy.
- Oestrogen or Progesterone positive
Exclusion Criteria
- Premenopausal.
- Preoperative hormonal/antihormonal/radiation/cytoxic chemo. Second malignant tumour/status post second malignant tumour.
- In-situ/T4 carcinoma.
- Age >80 years.
- World Health Organisation performance index >3.
- Serious accompanying diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To assess the difference in event free survival and overall survival (subject to stand-alone or combined/meta-analysis) between postmenopausal women with HR +ve early BC who switched from tamoxifen to anastrozole and those who continued on tamoxifen.
- Secondary Outcome Measures
Name Time Method To assess the difference in event free survival & overall survival (subject to stand-alone or combined/meta-analysis) plus side effects between postmenopausal women with HR+ve early BC who switched from tam to anastrozole and those who continued on tam.
Trial Locations
- Locations (3)
Research Site
🇦🇹Zams, Austria
Research Sites
🇦🇹Vienna, Austria
Research SIte
🇦🇹Melk, Austria