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ATAC - Quality of Life Sub-Protocol

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ClinicalTrials.gov Identifier: NCT00784680
Recruitment Status : Completed
First Posted : November 4, 2008
Last Update Posted : May 1, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
To compare Quality of Life between the ARIMIDEX group, the NOLVADEX group and the ARIMIDEX plus NOLVADEX combination group during the first two years of treatment. (a) To compare the difference in Quality of Life between the ARIMIDEX group and the NOLVADEX group (b) To compare Quality of Life in the ARIMIDEX plus NOLVADEX combination group with the NOLVADEX group for non-inferiority; if non inferiority is concluded, the difference in QOL between these two groups will be assessed.

Condition or disease Intervention/treatment Phase
Quality of Life Drug: Anastrozole Drug: Tamoxifen Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: A Randomised, Double-Blind, Parallel Group Trial to Assess Quality of Life With Arimidex Alone, Nolvadex Alone, or Arimidex and Nolvadex in Combination, When Used as Adjuvant Treatment for Breast Cancer in Postmenopausal Women
Study Start Date : April 1998
Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Time to withdrawal
  2. Time to recurrence

Eligibility Criteria

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
  • Completion of a baseline questionnaire

Exclusion Criteria:

  • Excluded from entry into the main ATAC trial (1033IL/0029)
  • If, in the investigators opinion, the patient would be unable to comply with this sub-protocol due to psychiatric or literacy reasons
More Information

Responsible Party: Francisco Sapunar, Medical Science Director, Arimidex and Faslodex, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00784680     History of Changes
Other Study ID Numbers: 1033IE/0029
D5392C08389
First Posted: November 4, 2008    Key Record Dates
Last Update Posted: May 1, 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