Adjuvant Endocrine Therapy in Postmenopausal Patients With HR +ve BC With Good to Moderate Differentiation - ARNO (Arimidex + Nolvadex). Primary Treatment for 2 Years With Tamoxifen Thereafter Randomisation to: Tamoxifen 3 Years or Anastrozole 3 Years.
N/A
80 Years
Female
Breast Cancer
Trial Information
Adjuvant Endocrine Therapy in Postmenopausal Patients With HR +ve BC With Good to Moderate Differentiation - ARNO (Arimidex + Nolvadex). Primary Treatment for 2 Years With Tamoxifen Thereafter Randomisation to: Tamoxifen 3 Years or Anastrozole 3 Years.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Principal Investigator
Raimund Jakesz, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Austrian Breast and Colorectal Cancer Study Group
Authority:
Austria: Federal Ministry for Health and Women
Study ID:
1033AU/0002
NCT ID:
NCT00291759
Start Date:
January 1996
Completion Date:
June 2009
Related Keywords:
- Breast Cancer
- Breast Neoplasms
Name | Location |
|---|
