Breast Neoplasms Clinical Trial
Official title:
A Randomized, Open, Comparative Multicentre Trial of 3 Years Anastrozole Treatment vs. 3 Years no Treatment in Postmenopausal Patients With Breast Cancer Who Have Completed 5 Years Adjuvant Hormone Therapy.
| Verified date | April 2009 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Austria: Federal Ministry for Health and Women |
| Study type | Interventional |
The study assesses the effect of a further 3 years adjuvant treatment with anastrozole vs. an untreated control group after initial 5 years of adjuvant hormone-therapy.
| Status | Completed |
| Enrollment | 856 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | N/A to 80 Years |
| Eligibility |
Inclusion Criteria: - No disease recurrence at time of randomization, - patients with breast cancer after surgery, - 5 years (+/- 12 months) of prior endocrine therapy Exclusion Criteria: - Premenopausal patients, - unknown or negative receptor status, - Secondary malignant tumor |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Austria | Research Site | Amstetten | |
| Austria | Research Site | Bad Ischl | |
| Austria | Research Site | Baden | |
| Austria | Research Site | Bregenz | |
| Austria | Research Site | Bruck an der Mur | |
| Austria | Research Site | Dornbirn | |
| Austria | Research Site | Eisenstadt | |
| Austria | Research Site | Feldbach | |
| Austria | Research Site | Feldkirch | |
| Austria | Research Site | Freistadt | |
| Austria | Research Site | Fuerstenfeld | |
| Austria | Research Site | Graz | |
| Austria | Research Site | Guessing | |
| Austria | Research Site | Hainburg | |
| Austria | Research Site | Hartberg | |
| Austria | Research site | Hollabrunn | |
| Austria | Research Site | Horn | |
| Austria | Research Site | Innsbruck | |
| Austria | Research Site | Kirchdorf | |
| Austria | Research Site | Klagenfurt | |
| Austria | Research Site | Klosterneuburg | |
| Austria | Research Site | Krems | |
| Austria | Research Site | Kufstein | |
| Austria | Research Site | Leoben | |
| Austria | Research Site | Linz | |
| Austria | Research Site | Mistelbach | |
| Austria | Research Site | Moedling | |
| Austria | Research Site | Neunkirche | |
| Austria | Research Site | Oberpullendorf | |
| Austria | Research Site | Oberwart | |
| Austria | Research Site | Ried im Innkreis | |
| Austria | Research Site | Rohrbach | |
| Austria | Research Site | Rottenmann | |
| Austria | Research Site | Salzburg | |
| Austria | Research Site | Sankt Pölten | |
| Austria | Research Site | Schaerding | |
| Austria | Research Site | Scheibbs | |
| Austria | Research Site | Schladming | |
| Austria | Research Site | Schwarzach | |
| Austria | Research Site | Spittal an der Drau | |
| Austria | Research Site | St. Poelten | |
| Austria | Research Site | St. Veit an der Glan | |
| Austria | Research Site | Steyr | |
| Austria | Research Site | Tulln | |
| Austria | Research Site | Villach | |
| Austria | Research Site | Voecklabruck | |
| Austria | Research Site | Waidhofen an der Ybbs | |
| Austria | Research Site | Wels | |
| Austria | Research Site | Wien | |
| Austria | Research Site | Wiener Neustadt | |
| Austria | Research Site | Wolfsberg | |
| Austria | Research Site | Zams |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Recurrence-free and overall survival | |||
| Secondary | Secondary cancers |
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