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Completed

NCT Number: NCT00286117

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

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.

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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

Up to 75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Arezzo, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

Anastrozole

Drug

oral

Other names: Arimidex, ZD1033

Tamoxifen

Drug

oral

Other names: Nolvadex

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Institute of Cancer Research, United Kingdom

Registry information

Official study 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

Important dates

Study start
1998
Study completion
2006
First posted
Feb 3, 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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