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ATAC - Endometrial Sub-Protocol

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00814125
First Posted: December 24, 2008
Last Update Posted: May 1, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

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:

  • 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
No Contacts or Locations Provided
  More Information

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
First Submitted: November 3, 2008
First Posted: December 24, 2008
Last Update Posted: May 1, 2009
Last Verified: April 2009

Keywords provided by AstraZeneca:
Endometrial
Endometrial histological findings

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
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