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ATAC - Endometrial Sub-Protocol

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ClinicalTrials.gov Identifier: NCT00814125
Recruitment Status : Completed
First Posted : December 24, 2008
Last Update Posted : May 1, 2009
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Anastrozole (Arimidex) Drug: Tamoxifen (Nolvadex) Drug: Nolvadex placebo Drug: Arimidex placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 285 participants
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
Study Start Date : June 1997
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Withdrawl
  2. Death

Eligibility Criteria

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)
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 Posted: December 24, 2008    Key Record Dates
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