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OpenTrials
Completed

NCT Number: NCT00849030

ATAC - Arimidex, Tamoxifen Alone or in Combination

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

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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 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

Treatment and study plan

Anastozole (Arimidex)

Drug

1mg, orally, once daily

Other names: Arimidex

Tamoxifen (Nolvadex)

Drug

20mg, orally, once daily

Other names: Nolvadex

Anastozole (Arimidex) placebo

Drug

1mg, orally, once daily

Tamoxifen (Nolvadex) placebo

Drug

20mg, orally, once daily

Primary outcomes

  1. Time to recurrence of breast cancer

    Time frame: Earliest of local or distant recurrence, new primary breast cancer, or death

  2. Safety and side effects

    Time frame: Earliest of local or distant recurrence, new primary breast cancer, or death

Secondary outcomes

  1. Time to distant recurrence

    Time frame: Earliest of local or distant recurrence, new primary breast cancer, or death

  2. Survival

    Time frame: Earliest of local or distant recurrence, new primary breast cancer, or death

  3. New breast primaries

    Time frame: Earliest of local or distant recurrence, new primary breast cancer, or death

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
1996
Primary completion
2001
Study completion
2010
First posted
Feb 23, 2009
Registry last updated
Jun 6, 2012

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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