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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00286117
• Other study ID #: 1033IT/0002
• Secondary ID: ITA
• Status: Completed
• Phase: Phase 3
• First received: February 2, 2006
• Last updated: April 30, 2009
• Start date: March 1998
• Est. completion date: May 2006

Study information

• Verified date: April 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 448
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 75 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Anastrozole
oral
• Tamoxifen
oral

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Institute of Cancer Research, United Kingdom

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.

External Links

•   AstraZeneca Clinical Study Information