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Completed

NCT Number: NCT00814125

ATAC - Endometrial Sub-Protocol

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Anastrozole (Arimidex)

Drug

1mg, orally, once daily

Other names: Arimidex

Tamoxifen (Nolvadex)

Drug

20mg, orally, once daily

Other names: Nolvadex

Nolvadex placebo

Drug

Arimidex placebo

Drug

Primary outcomes

  1. Withdrawl

  2. Death

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
1997
Study completion
2005
First posted
Dec 24, 2008
Registry last updated
May 1, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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