ATAC - Arimidex, Tamoxifen Alone or in Combination - Full Text View

Purpose

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Tamoxifen Tamoxifen citrate Anastrozole

U.S. FDA Resources

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

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov 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
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013