ATAC - Bone Density Sub-Protocol

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. Identifier: NCT00784940
Recruitment Status : Completed
First Posted : November 4, 2008
Last Update Posted : April 27, 2009
Information provided by:

November 3, 2008
November 4, 2008
April 27, 2009
June 1998
March 2005   (Final data collection date for primary outcome measure)
  • Time to withdrawal
  • Time to recurrence
Same as current
Complete list of historical versions of study NCT00784940 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
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
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
    • 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 Identifier (NCT Number) in Medline.
Same as current
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
Sexes Eligible for Study: Female
45 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Francisco Sapunar, Medical Science Director, Arimidex and Faslodex, AstraZeneca Pharmaceuticals
Not Provided
Not Provided
April 2009

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