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ATAC - Arimidex, Tamoxifen Alone or in Combination

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: February 20, 2009
Last updated: June 5, 2012
Last verified: June 2012
The aim of this study is to test whether Arimidex alone or in combination with Tamoxifen is beneficial in the treatment of breast cancer.

Condition Intervention Phase
Breast Cancer
Drug: Anastozole (Arimidex)
Drug: Tamoxifen (Nolvadex)
Drug: Anastozole (Arimidex) placebo
Drug: Tamoxifen (Nolvadex) placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double Blind Trial Comparing Arimidex Alone With Nolvadex Alone With Arimidex and Nolvadex in Combination, as Adjuvant Treatment in Post-Menopausal Women With Breast Cancer

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to recurrence of breast cancer [ Time Frame: Earliest of local or distant recurrence, new primary breast cancer, or death ] [ Designated as safety issue: No ]
  • Safety and side effects [ Time Frame: Earliest of local or distant recurrence, new primary breast cancer, or death ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to distant recurrence [ Time Frame: Earliest of local or distant recurrence, new primary breast cancer, or death ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: Earliest of local or distant recurrence, new primary breast cancer, or death ] [ Designated as safety issue: No ]
  • New breast primaries [ Time Frame: Earliest of local or distant recurrence, new primary breast cancer, or death ] [ Designated as safety issue: No ]

Enrollment: 9358
Study Start Date: July 1996
Study Completion Date: April 2010
Primary Completion Date: June 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Arimidex 1mg + Nolvadex placebo
Drug: Anastozole (Arimidex)
1mg, orally, once daily
Other Name: Arimidex
Drug: Tamoxifen (Nolvadex) placebo
20mg, orally, once daily
Active Comparator: 2
Arimidex placebo + Nolvadex 20mg
Drug: Tamoxifen (Nolvadex)
20mg, orally, once daily
Other Name: Nolvadex
Drug: Anastozole (Arimidex) placebo
1mg, orally, once daily
Active Comparator: 3
Arimidex 1mg + Nolvadex 20mg
Drug: Anastozole (Arimidex)
1mg, orally, once daily
Other Name: Arimidex
Drug: Tamoxifen (Nolvadex)
20mg, orally, once daily
Other Name: Nolvadex


Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with histologically proven operable invasive breast cancer
  • Patients who have completed all primary surgery and chemotherapy (if given), and are candidates to receive hormonal adjuvant therapy
  • Women defined as post-menopausal

Exclusion Criteria:

  • Patients in whom there is any clinical evidence of metastatic disease
  • Patients who, for whatever reason (e.g. confusion, infirmity, alcoholism), are unlikely to comply with trial requirements
  • Patients whose chemotherapy was started more than 8 weeks (ie 56 days) after completion of primary surgery or whose chemotherapy was completed more than 8 weeks (ie 56 days) before starting randomised treatment
  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.

No Contacts or Locations Provided
  More Information

Responsible Party: AstraZeneca Identifier: NCT00849030     History of Changes
Other Study ID Numbers: 1033IL/0029  D5392C00029 
Study First Received: February 20, 2009
Last Updated: June 5, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Argentina: Human Research Bioethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board
Belgium: Ministry of Social Affairs, Public Health and the Environment
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Canada: Health Canada
Canada: Ministry of Health & Long Term Care, Ontario
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Direction Générale de la Santé
France: French Data Protection Authority
France: Institutional Ethical Committee
France: Ministry of Health
France: National Consultative Ethics Committee for Health and Life Sciences
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Germany: Federal Ministry of Education and Research
Germany: German Institute of Medical Documentation and Information
Germany: Ministry of Health
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Ireland: Medical Ethics Research Committee
Ireland: Ministry of Health
Italy: Ethics Committee
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Netherlands: Independent Ethics Committee
Netherlands: Dutch Health Care Inspectorate
Netherlands: Medical Ethics Review Committee (METC)
Netherlands: Medicines Evaluation Board (MEB)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
New Zealand: Health Research Council
New Zealand: Health and Disability Ethics Committees
New Zealand: Institutional Review Board
New Zealand: Medsafe
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Ministry of Health
Poland: Ministry of Science and Higher Education
Portugal: Ethics Committee for Clinical Research
Portugal: Health Ethic Committee
Portugal: National Pharmacy and Medicines Institute
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
South Africa: National Health Research Ethics Council
Spain: Comité Ético de Investigación Clínica
Spain: Ethics Committee
Spain: Ministry of Health
Spain: Ministry of Health and Consumption
Spain: Spanish Agency of Medicines
Sweden: Institutional Review Board
Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
Sweden: Swedish National Council on Medical Ethics
Sweden: Swedish Research Council
Sweden: The National Board of Health and Welfare
Turkey: Ethics Committee
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents processed this record on October 26, 2016