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

November 3, 2008
April 24, 2009
June 1998
March 2005   (final data collection date for primary outcome measure)
  • Time to withdrawal [ Designated as safety issue: No ]
  • Time to recurrence [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00784940 on ClinicalTrials.gov Archive Site
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ATAC - Bone Density Sub-Protocol
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Bone Density
  • Drug: Anastrozole
    1mg, orally, once daily
    Other Name: Arimidex
  • Drug: Tamoxifen
    20mg, orally, once daily
    Other Name: Nolvadex
  • Active Comparator: 1
    Arimidex 1mg + Nolvadex placebo
    Intervention: Drug: Anastrozole
  • Active Comparator: 2
    Arimidex placebo + Nolvadex 20mg
    Interventions:
    • Drug: Anastrozole
    • Drug: Tamoxifen
  • Active Comparator: 3
    Arimidex 1mg + Nolvadex 20mg
    Intervention: Drug: Tamoxifen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
308
April 2007
March 2005   (final data collection date for primary outcome measure)

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
Female
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00784940
1033ID/0029, D5392C01985
Yes
Francisco Sapunar, Medical Science Director, Arimidex and Faslodex, AstraZeneca Pharmaceuticals
AstraZeneca
Not Provided
Not Provided
AstraZeneca
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP