ATAC - Endometrial Sub-Protocol

Breast Cancer Clinical Trial

Official title:

A Randomised, Double Blind Trial to Assess the Incidence of Endometrial Changes 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: NCT00814125
• Other study ID #: 1033IC/0029
• Secondary ID: D5392C06736
• Status: Completed
• Phase: Phase 3
• First received: November 3, 2008
• Last updated: April 30, 2009
• Start date: June 1997
• Est. completion date: December 2005

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 CouncilBelgium: Federal Agency for Medicines and Health Products, FAMHPBelgium: Federal Agency for Medicinal Products and Health ProductsBelgium: Institutional Review BoardBelgium: Ministry of Social Affairs, Public Health and the EnvironmentBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentFrance: 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 SciencesGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesGermany: Federal Ministry of Education and ResearchGermany: German Institute of Medical Documentation and InformationGermany: Ministry of HealthNetherlands: 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)Portugal: Ethics Committee for Clinical ResearchPortugal: Health Ethic CommitteePortugal: National Pharmacy and Medicines InstituteSouth 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 the difference between the ARIMIDEX group and the tamoxifen group in the incidence of abnormal endometrial histological findings arising after treatment has commenced.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Patients eligible for entry into the main ATAC trial (1033IL/0029)

• Not received any previous tamoxifen, for whatever reason

• Not undergone a hysterectomy and do not have a hysterectomy planned within the next 6 years

• No previous endometrial ablation

Exclusion Criteria:

• Excluded from entry into the main ATAC trial (1033IL/0029). As detailed in Section 4.4 of the main ATAC trial (1033IL/0029)

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• Anastrozole (Arimidex)
1mg, orally, once daily
• Tamoxifen (Nolvadex)
20mg, orally, once daily
• Nolvadex placebo

• Arimidex placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Withdrawl
Primary	Death