Status:
COMPLETED
ATAC - Bone Density Sub-Protocol
Lead Sponsor:
AstraZeneca
Conditions:
Bone Density
Eligibility:
FEMALE
45+ years
Phase:
PHASE3
Brief Summary
To assess and quantify the changes in bone mineral density between the ARIMIDEX and ARIMIDEX plus NOLVADEX groups when compared to the NOLVADEX alone treatment group whilst receiving trial therapy.
Eligibility Criteria
Inclusion
- Eligible for entry into the main ATAC trial 1033IL/0029
- Women defined as post-menopausal
- Patients with histologically proven operable invasive breast cancer
- Who following primary surgery have a good prognosis and would be ethically suitable to remain untreated
Exclusion
- Excluded from entry into the main ATAC trial (1033IL/0029)
- Patients who have received hormone replacement therapy within the previous 12 months prior to randomisation
- Patients who have received bisphosphonate therapy within the previous 12 months prior to randomisation
- Patients who have had a bone fracture within the previous 6 months prior to randomisation
Key Trial Info
Start Date :
June 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT00784940
Start Date
June 1 1998
End Date
April 1 2007
Last Update
April 27 2009
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