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

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ClinicalTrials.gov Identifier: NCT00300508
Recruitment Status : Completed
First Posted : March 9, 2006
Last Update Posted : May 1, 2009
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Anastrozole Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 856 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Study Start Date : January 1996

Resource links provided by the National Library of Medicine

Drug Information available for: Anastrozole
U.S. FDA Resources

Primary Outcome Measures :
  1. Recurrence-free and overall survival

Secondary Outcome Measures :
  1. Secondary cancers

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00300508

  Show 52 Study Locations
Sponsors and Collaborators
Study Director: AstraZeneca Austria Medical Director, MD AstraZeneca

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00300508     History of Changes
Other Study ID Numbers: 1033AU/0001
First Posted: March 9, 2006    Key Record Dates
Last Update Posted: May 1, 2009
Last Verified: April 2009

Keywords provided by AstraZeneca:
Hormone receptor positive breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs