Status:
COMPLETED
Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid
Lead Sponsor:
Austrian Breast & Colorectal Cancer Study Group
Collaborating Sponsors:
AstraZeneca
Novartis Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
FEMALE
19-59 years
Phase:
PHASE3
Brief Summary
The primary objective is, first, the comparison of tamoxifen and anastrozole and, second, the comparison of zoledronate added to standard adjuvant therapy with controls according to disease-free survi...
Detailed Description
The trial is conducted as an open multi-center phase III study, in a two-factorial study design and according to Good Clinical Practice (GCP) guidelines. Patients will be randomly assigned to a total ...
Eligibility Criteria
Inclusion
- Premenopausal, hormone receptor-positive patient
- Histologically verified (minimally) invasive breast cancer, local radical treatment
- 0-9 involved axillary lymph nodes (≥ 10 histologically examined nodes)
- Tumor stage: pT1b-3, yT0 or yT1a
Exclusion
- T1a, T4d, yT4; M1
- Previous breast tumor irradiation
- Previous or concurrent chemotherapy (except for preoperative chemotherapy)
- Serum creatinine \> 1.5 x UNL or creatinine clearance \< 60 ml/min
Key Trial Info
Start Date :
June 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2018
Estimated Enrollment :
1803 Patients enrolled
Trial Details
Trial ID
NCT00295646
Start Date
June 1 1999
End Date
June 26 2018
Last Update
March 15 2024
Active Locations (72)
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1
Hospital of Guessing
Güssing, Burgenland, Austria, 7540
2
Hospital Oberpullendorf
Oberpullendorf, Burgenland, Austria, 7350
3
Hospital Oberwart
Oberwart, Burgenland, Austria, 7400
4
State Hospital Klagenfurt, Surgery
Klagenfurt, Carinthia, Austria, 9026