ITA - Clinical Study Comparing ARIMIDEX™ With NOLVADEX™ in Women With Breast Cancer Treated With NOLVADEX for at Least 2 Years
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
2 other identifiers
interventional
448
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Mar 1998
Typical duration for phase_3 breast-cancer
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 1998
CompletedFirst Submitted
Initial submission to the registry
February 2, 2006
CompletedFirst Posted
Study publicly available on registry
February 3, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedMay 1, 2009
April 1, 2009
February 2, 2006
April 30, 2009
Conditions
Keywords
Outcome Measures
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.
Study Arms (2)
1
EXPERIMENTALAnastrozole
2
ACTIVE COMPARATORTamoxifen
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Institute of Cancer Research, United Kingdomcollaborator
Study Sites (25)
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
Florence, Italy
Research Site
Forlì, Italy
Research Site
Genova, Italy
Research Site
Lugo, Italy
Research Site
Messina, Italy
Research Site
Milan, 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
Sanremo, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Arimidex Medical Science Director, MD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Francesco Boccardo, MD
University and National Cancer Research Institute
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 2, 2006
First Posted
February 3, 2006
Study Start
March 1, 1998
Study Completion
May 1, 2006
Last Updated
May 1, 2009
Record last verified: 2009-04