ATAC - Quality of Life Sub-Protocol

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00784680
• Other study ID #: 1033IE/0029
• Secondary ID: D5392C08389
• Status: Completed
• Phase: Phase 3
• First received: November 3, 2008
• Last updated: April 30, 2009
• Start date: April 1998
• Est. completion date: April 2004

Study information

• Verified date: April 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: Human Research Ethics CommitteeAustralia: National Health and Medical Research CouncilFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Direction Générale de la SantéFrance: French Data Protection AuthorityFrance: Institutional Ethical CommitteeFrance: Ministry of HealthFrance: National Consultative Ethics Committee for Health and Life SciencesItaly: Ethics CommitteeItaly: Ministry of HealthItaly: National Bioethics CommitteeItaly: National Institute of HealthItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthItaly: The Italian Medicines AgencyNetherlands: Independent Ethics CommitteeNetherlands: Dutch Health Care InspectorateNetherlands: Medical Ethics Review Committee (METC)Netherlands: Medicines Evaluation Board (MEB)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)New Zealand: Health Research CouncilNew Zealand: Health and Disability Ethics CommitteesNew Zealand: Institutional Review BoardNew Zealand: MedsafeSouth Africa: Medicines Control CouncilSouth Africa: National Health Research Ethics CouncilSpain: Comité Ético de Investigación ClínicaSpain: Ethics CommitteeSpain: Ministry of HealthSpain: Ministry of Health and ConsumptionSpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Quality of Life

Intervention

Drug:
• Anastrozole
1mg, orally, once daily
• Tamoxifen
20mg, orally, once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to withdrawal			No
Primary	Time to recurrence			No