ABCSG 8 - Adjuvant Treatment in Patients With Hormone Receptor-positive Breast Cancer With Good to Moderate Differentiation.
This study has been completed.
Information provided by (Responsible Party):
First received: February 13, 2006
Last updated: January 29, 2013
Last verified: January 2013
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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.
Primary Outcome Measures:
- 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:
- 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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2009 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||up to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00291759
||Raimund Jakesz, MD
||Austrian Breast and Colorectal Cancer Study Group
||AstraZeneca Austria Medical Director, MD
No publications provided
History of Changes
|Other Study ID Numbers:
||1033AU/0002, ABCSG 8
|Study First Received:
||February 13, 2006
||January 29, 2013
||Austria: Federal Ministry for Health and Women
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Neoplasms by Site
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Molecular Mechanisms of Pharmacological Action