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ITA - Clinical Study Comparing ARIMIDEX™ With NOLVADEX™ in Women With Breast Cancer Treated With NOLVADEX for at Least 2 Years

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00286117
Recruitment Status : Completed
First Posted : February 3, 2006
Last Update Posted : May 1, 2009
Sponsor:
Collaborator:
Institute of Cancer Research, United Kingdom
Information provided by:
AstraZeneca

Study Description
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Brief Summary:
The purpose of this study was to assess the difference in disease-free survival between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued on tamoxifen.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 448 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Randomised Clinical Study Comparing ARIMIDEX™ With NOLVADEX™ as Adjuvant Therapies in Post-Menopausal Women With Breast Cancer Already Being Treated With NOLVADEX for at Least Two Years
Study Start Date : March 1998
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Anastrozole
 Drug: Anastrozole
oral
Other Names:
  • Arimidex
  • ZD1033
Active Comparator: 2
Tamoxifen
 Drug: Tamoxifen
oral
Other Name: Nolvadex


Outcome Measures
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Primary Outcome Measures :
  1. The primary objective of this analysis was to assess the difference in disease-free survival between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued on tamoxifen

Secondary Outcome Measures :
  1. Assess the difference in overall survival/disease recurrence/safety and tolerability between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen.

Eligibility Criteria
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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Post-menopausal status; age ≤75 years;
  • histologically confirmed invasive breast cancer with metastases in the axillary lymph nodes;
  • oestrogen receptor status positive or unknown;
  • primary treatment (surgery +/- radiotherapy, +/- chemotherapy) completed

Exclusion Criteria:

  • Clinical evidence of metastatic disease (including local or remote recurrence, even if the patient appeared to be in complete remission at the time of randomisation).
Contacts and Locations
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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): NCT00286117


Locations
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Italy
Research Site
Arezzo, Italy
Research Site
Bologna, Italy
Research Site
Casalpusterlengo, Italy
Research Site
Catania, Italy
Research Site
Chieti, Italy
Research Site
Ferrara, Italy
Research Site
Firenze, Italy
Research Site
Forli, Italy
Research Site
Genova, Italy
Research Site
Lugo, Italy
Research Site
Messina, Italy
Research Site
Milano, Italy
Research Site
Monserrato, Italy
Research Site
Palermo, Italy
Research Site
Pavia, Italy
Research Site
Pinerolo, Italy
Research Site
Roma, Italy
Research Site
Rovigo, Italy
Research Site
San Remo, Italy
Research Site
Saronno, Italy
Research Site
Sassari, Italy
Research Site
Terni, Italy
Research Site
Torino, Italy
Research Site
Trieste, Italy
Research Site
Vicenza, Italy
Sponsors and Collaborators
AstraZeneca
Institute of Cancer Research, United Kingdom
Investigators
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Study Director: AstraZeneca Arimidex Medical Science Director, MD AstraZeneca
Principal Investigator: Francesco Boccardo, MD University and National Cancer Research Institute
More Information
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Additional Information:

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Responsible Party: Francisco Sapunar, MD - Arimidex Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00286117    
Other Study ID Numbers: 1033IT/0002
ITA
First Posted: February 3, 2006    Key Record Dates
Last Update Posted: May 1, 2009
Last Verified: April 2009
Keywords provided by AstraZeneca:
Breast Cancer
Additional relevant MeSH terms:
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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