ABCSG 8 - Adjuvant Treatment in Patients With Hormone Receptor-positive Breast Cancer With Good to Moderate Differentiation.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00291759
First received: February 13, 2006
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Tamoxifen
Drug: Anastrozole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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.

Enrollment: 3858
Study Start Date: January 1996
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291759

  Show 52 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Raimund Jakesz, MD Austrian Breast and Colorectal Cancer Study Group
Study Director: AstraZeneca Austria Medical Director, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00291759     History of Changes
Other Study ID Numbers: 1033AU/0002, ABCSG 8
Study First Received: February 13, 2006
Last Updated: January 29, 2013
Health Authority: Austria: Federal Ministry for Health and Women

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Anastrozole
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014