ATAC - Endometrial Sub-Protocol

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00814125
First received: November 3, 2008
Last updated: April 30, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Anastrozole (Arimidex)
Drug: Tamoxifen (Nolvadex)
Drug: Nolvadex placebo
Drug: Arimidex placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Withdrawl
  • Death

Enrollment: 285
Study Start Date: June 1997
Study Completion Date: December 2005
Arms Assigned Interventions
Active Comparator: 1
Arimidex 1mg + Nolvadex placebo
Drug: Anastrozole (Arimidex)
1mg, orally, once daily
Other Name: Arimidex
Drug: Nolvadex placebo
Active Comparator: 2
Arimidex placebo + Nolvadex 20mg
Drug: Tamoxifen (Nolvadex)
20mg, orally, once daily
Other Name: Nolvadex
Drug: Arimidex placebo
Active Comparator: 3
Arimidex 1mg + Nolvadex 20mg
Drug: Anastrozole (Arimidex)
1mg, orally, once daily
Other Name: Arimidex
Drug: Tamoxifen (Nolvadex)
20mg, orally, once daily
Other Name: Nolvadex

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Francisco Sapunar, Medical Science Director, Arimidex and Faslodex, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00814125     History of Changes
Other Study ID Numbers: 1033IC/0029, D5392C06736
Study First Received: November 3, 2008
Last Updated: April 30, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board
Belgium: Ministry of Social Affairs, Public Health and the Environment
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Direction Générale de la Santé
France: French Data Protection Authority
France: Institutional Ethical Committee
France: Ministry of Health
France: National Consultative Ethics Committee for Health and Life Sciences
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Germany: Federal Ministry of Education and Research
Germany: German Institute of Medical Documentation and Information
Germany: Ministry of Health
Netherlands: Independent Ethics Committee
Netherlands: Dutch Health Care Inspectorate
Netherlands: 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 Research
Portugal: Health Ethic Committee
Portugal: National Pharmacy and Medicines Institute
South Africa: Medicines Control Council
South Africa: National Health Research Ethics Council
Spain: Comité Ético de Investigación Clínica
Spain: Ethics Committee
Spain: Ministry of Health
Spain: Ministry of Health and Consumption
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by AstraZeneca:
Endometrial
Endometrial histological findings

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Tamoxifen
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 18, 2014