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OpenTrials
Completed

NCT Number: NCT00300508

3 Years of Anastrozole vs. no Treatment as Extended Adjuvant Therapy for Postmenopausal Women With Breast Cancer

The study assesses the effect of a further 3 years adjuvant treatment with anastrozole vs. an untreated control group after initial 5 years of adjuvant hormone-therapy.

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Key information

Conditions

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

Age range

Up to 80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Amstetten, Austria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • No disease recurrence at time of randomization,
  • patients with breast cancer after surgery,
  • 5 years (+/- 12 months) of prior endocrine therapy

Exclusion criteria

  • Premenopausal patients,
  • unknown or negative receptor status,
  • Secondary malignant tumor

Treatment and study plan

Anastrozole

Drug

Primary outcomes

  1. Recurrence-free and overall survival

Secondary outcomes

  1. Secondary cancers

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomized, Open, Comparative Multicentre Trial of 3 Years Anastrozole Treatment vs. 3 Years no Treatment in Postmenopausal Patients With Breast Cancer Who Have Completed 5 Years Adjuvant Hormone Therapy.

Important dates

Study start
1996
First posted
Mar 9, 2006
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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