Breast Cancer
Conditions
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.
Interventions
DRUGTamoxifen
DRUGAnastrozole
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Austria
Outcome results
None listed