ATAC - Arimidex, Tamoxifen Alone or in Combination
A Randomised, Double Blind Trial Comparing Arimidex Alone With Nolvadex Alone With Arimidex and Nolvadex in Combination, as Adjuvant Treatment in Post-Menopausal Women With Breast Cancer
2 other identifiers
interventional
9,358
0 countries
N/A
Brief Summary
The aim of this study is to test whether Arimidex alone or in combination with Tamoxifen is beneficial in the treatment of breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Jul 1996
Longer than P75 for phase_3 breast-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1996
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2001
CompletedFirst Submitted
Initial submission to the registry
February 20, 2009
CompletedFirst Posted
Study publicly available on registry
February 23, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedJune 6, 2012
June 1, 2012
4.9 years
February 20, 2009
June 5, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
Time to recurrence of breast cancer
Earliest of local or distant recurrence, new primary breast cancer, or death
Safety and side effects
Earliest of local or distant recurrence, new primary breast cancer, or death
Secondary Outcomes (3)
Time to distant recurrence
Earliest of local or distant recurrence, new primary breast cancer, or death
Survival
Earliest of local or distant recurrence, new primary breast cancer, or death
New breast primaries
Earliest of local or distant recurrence, new primary breast cancer, or death
Study Arms (3)
1
ACTIVE COMPARATORArimidex 1mg + Nolvadex placebo
2
ACTIVE COMPARATORArimidex placebo + Nolvadex 20mg
3
ACTIVE COMPARATORArimidex 1mg + Nolvadex 20mg
Interventions
Eligibility Criteria
You may qualify if:
- Patients with histologically proven operable invasive breast cancer
- Patients who have completed all primary surgery and chemotherapy (if given), and are candidates to receive hormonal adjuvant therapy
- Women defined as post-menopausal
You may not qualify if:
- Patients in whom there is any clinical evidence of metastatic disease
- Patients who, for whatever reason (e.g. confusion, infirmity, alcoholism), are unlikely to comply with trial requirements
- Patients whose chemotherapy was started more than 8 weeks (ie 56 days) after completion of primary surgery or whose chemotherapy was completed more than 8 weeks (ie 56 days) before starting randomised treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2009
First Posted
February 23, 2009
Study Start
July 1, 1996
Primary Completion
June 1, 2001
Study Completion
April 1, 2010
Last Updated
June 6, 2012
Record last verified: 2012-06