ATAC - Bone Density Sub-Protocol

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00784940
First received: November 3, 2008
Last updated: April 24, 2009
Last verified: April 2009
  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:


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
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

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: 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
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
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 July 31, 2014