ATAC - Arimidex, Tamoxifen Alone or in Combination

Breast Cancer Clinical Trial

Official title:

A Randomised, Double Blind Trial Comparing Arimidex Alone With Nolvadex Alone With Arimidex and Nolvadex in Combination, as Adjuvant Treatment in Post-Menopausal Women With Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00849030
• Other study ID #: 1033IL/0029
• Secondary ID: D5392C00029
• Status: Completed
• Phase: Phase 3
• First received: February 20, 2009
• Last updated: June 5, 2012
• Start date: July 1996
• Est. completion date: April 2010

Study information

• Verified date: June 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaArgentina: Human Research Bioethics CommitteeAustralia: 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 EnvironmentCanada: Canadian Institutes of Health ResearchCanada: Ethics Review CommitteeCanada: Health CanadaCanada: Ministry of Health & Long Term Care, OntarioCzech Republic: Ethics CommitteeCzech Republic: State Institute for Drug ControlFrance: 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 HealthHungary: National Institute of PharmacyIreland: Irish Medicines BoardIreland: Medical Ethics Research CommitteeIreland: Ministry of HealthItaly: 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: MedsafePoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPoland: Ministry of HealthPoland: Ministry of Science and Higher EducationPortugal: Ethics Committee for Clinical ResearchPortugal: Health Ethic CommitteePortugal: National Pharmacy and Medicines InstituteSlovakia: State Institute for Drug ControlSouth 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 MedicinesSweden: Institutional Review BoardSweden: Medical Products AgencySweden: Regional Ethical Review BoardSweden: Swedish National Council on Medical EthicsSweden: Swedish Research CouncilSweden: The National Board of Health and WelfareTurkey: Ethics CommitteeTurkey: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to test whether Arimidex alone or in combination with Tamoxifen is beneficial in the treatment of breast cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9358
• Est. completion date: April 2010
• Est. primary completion date: June 2001
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Patients with histologically proven operable invasive breast cancer

• Patients who have completed all primary surgery and chemotherapy (if given), and are candidates to receive hormonal adjuvant therapy

• Women defined as post-menopausal

Exclusion Criteria:

• Patients in whom there is any clinical evidence of metastatic disease

• Patients who, for whatever reason (e.g. confusion, infirmity, alcoholism), are unlikely to comply with trial requirements

• Patients whose chemotherapy was started more than 8 weeks (ie 56 days) after completion of primary surgery or whose chemotherapy was completed more than 8 weeks (ie 56 days) before starting randomised treatment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• Anastozole (Arimidex)
1mg, orally, once daily
• Tamoxifen (Nolvadex)
20mg, orally, once daily
• Anastozole (Arimidex) placebo
1mg, orally, once daily
• Tamoxifen (Nolvadex) placebo
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 recurrence of breast cancer		Earliest of local or distant recurrence, new primary breast cancer, or death	No
Primary	Safety and side effects		Earliest of local or distant recurrence, new primary breast cancer, or death	Yes
Secondary	Time to distant recurrence		Earliest of local or distant recurrence, new primary breast cancer, or death	No
Secondary	Survival		Earliest of local or distant recurrence, new primary breast cancer, or death	No
Secondary	New breast primaries		Earliest of local or distant recurrence, new primary breast cancer, or death	No

External Links

•   Cancer Study Locator (US and Canada only)