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ATAC - Bone Density Sub-Protocol

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00784940
First Posted: November 4, 2008
Last Update Posted: April 27, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
  • Time to recurrence

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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes 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

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
First Submitted: November 3, 2008
First Posted: November 4, 2008
Last Update Posted: April 27, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Tamoxifen
Anastrozole
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action