ATAC - Bone Density Sub-Protocol - Full Text View

Purpose

To assess and quantify the changes in bone mineral density between the ARIMIDEX and ARIMIDEX plus NOLVADEX groups when compared to the NOLVADEX alone treatment group whilst receiving trial therapy.

Condition	Intervention	Phase
Bone Density	Drug: Anastrozole Drug: Tamoxifen	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator)
Official Title:	A Randomised, Double-Blind Trial to Assess the Effects on Bone Mineral Density and Metabolism of Arimidex Alone, Nolvadex Alone, or Arimidex and Nolvadex in Combination, (in Comparison to a Control Group) When Used as Adjuvant Treatment for Breast Cancer in Postmenopausal Women

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Bone Density Minerals

Drug Information available for: Tamoxifen Tamoxifen citrate Anastrozole

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Time to withdrawal [ Designated as safety issue: No ]
Time to recurrence [ Designated as safety issue: No ]

Enrollment:	308
Study Start Date:	June 1998
Study Completion Date:	April 2007
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Arimidex 1mg + Nolvadex placebo	Drug: Anastrozole 1mg, orally, once daily Other Name: Arimidex
Active Comparator: 2 Arimidex placebo + Nolvadex 20mg	Drug: Anastrozole 1mg, orally, once daily Other Name: Arimidex Drug: Tamoxifen 20mg, orally, once daily Other Name: Nolvadex
Active Comparator: 3 Arimidex 1mg + Nolvadex 20mg	Drug: Tamoxifen 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:

Eligible for entry into the main ATAC trial 1033IL/0029
Women defined as post-menopausal
Patients with histologically proven operable invasive breast cancer
Who following primary surgery have a good prognosis and would be ethically suitable to remain untreated

Exclusion Criteria:

Excluded from entry into the main ATAC trial (1033IL/0029)
Patients who have received hormone replacement therapy within the previous 12 months prior to randomisation
Patients who have received bisphosphonate therapy within the previous 12 months prior to randomisation
Patients who have had a bone fracture within the previous 6 months prior to randomisation

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Francisco Sapunar, Medical Science Director, Arimidex and Faslodex, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00784940 History of Changes
Other Study ID Numbers:	1033ID/0029, D5392C01985
Study First Received:	November 3, 2008
Last Updated:	April 24, 2009
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines 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 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 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) South Africa: Medicines Control Council South Africa: National Health Research Ethics Council 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 United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Ethics Committee United States: Food and Drug Administration United States: Institutional Review Board

Additional relevant MeSH terms:

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 May 16, 2013