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Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid
Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid

NCT00295646

CompletedPhase 3

Sponsor: Austrian Breast & Colorectal Cancer Study Group

Conditions: Breast Cancer

Interventions: tamoxifen, anastrozole, zoledronic acid, goserelin

Countries: Austria, Germany

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 survival (DFS) in premenopausal patients with non-metastatic breast cancer treated with tamoxifen or anastrozole. To assess whether zoledronate added to standard adjuvant therapy can decrease or even prevent bone loss in patients treated with hormonal blockade combined with an antiestrogen or aromatase inhibitor.

Eligibility overview

Sex: FEMALE

Age: 19 Years to 59 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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
Locations (72)
  • Guessing, Burgenland, Austria
  • Oberpullendorf, Burgenland, Austria
  • Oberwart, Burgenland, Austria
  • Klagenfurt, Carinthia, Austria
  • Klagenfurt, Carinthia, Austria
  • Saint Veit A. D. Glan, Carinthia, Austria
  • Saint Veit A. D. Glan, Carinthia, Austria
  • Villach, Carinthia, Austria
  • Villach, Carinthia, Austria
  • Wolfsberg, Carinthia, Austria
  • Hainburg an der Donau, Lower Austria, Austria
  • Klosterneuburg, Lower Austria, Austria
  • Krems, Lower Austria, Austria
  • Melk, Lower Austria, Austria
  • Mistelbach, Lower Austria, Austria
  • Mödling, Lower Austria, Austria
  • Neunkirchen, Lower Austria, Austria
  • Sankt Pölten, Lower Austria, Austria
  • Scheibbs, Lower Austria, Austria
  • Tulln, Lower Austria, Austria
  • Waidhofen an der Thaya, Lower Austria, Austria
  • Wiener Neustadt, Lower Austria, Austria
  • Schwarzach, State of Salzburg, Austria
  • Feldbach, Styria, Austria
  • Graz, Styria, Austria
  • Graz, Styria, Austria
  • Leoben, Styria, Austria
  • Rottenmann, Styria, Austria
  • Weiz, Styria, Austria
  • Hall in Tirol, Tyrol, Austria
  • + 42 more on CT.gov