Spots Global Cancer Trial Database for Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid
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Trial Identification
Brief Title: Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid
Official Title: Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid, in Premenopausal, Hormone Receptor-positive Breast Cancer Patients (Stage I, II)
Study ID: NCT00295646
Conditions
Study Description
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 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.
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 of 4 study groups in a 1:1:1:1 assignment ratio. Several stratification criteria will be used in order to ensure balanced distribution of known risk factors. A total of 1.803 patients will be enrolled in 4 arms. Patients will either be treated with anastrozole (1mg daily for 3 years) or tamoxifen (20mg daily for 3 years), and will additionally receive either zoledronate (8mg q4 weeks for 3 years) or no zoledronate (arm A: Nolvadex alone; arm B: Nolvadex plus zoledronate; arm C: Arimidex alone; arm D: Arimidex plus zoledronate). Zoledronate will be administered by i.v. injection at a dose of 4 mg/month for the treatment period of 3 years. Five Bone Mineral Density (BMD) measurements will be performed in a subgroup of patients (404 patients, enrolled in 3 centres).
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Hospital of Guessing, Guessing, Burgenland, Austria
Hospital Oberpullendorf, Oberpullendorf, Burgenland, Austria
Hospital Oberwart, Oberwart, Burgenland, Austria
State Hospital Klagenfurt, Surgery, Klagenfurt, Carinthia, Austria
State Hospital Klagenfurt, Klagenfurt, Carinthia, Austria
Hospital BHB St. Veit, St. Veit a. d. Glan, Carinthia, Austria
Ordination Dr. Wette, St. Veit a. d. Glan, Carinthia, Austria
State Hospital Villach, Villach, Carinthia, Austria
Privat Hospital Villach, Villach, Carinthia, Austria
State Hospital Wolfsberg, Wolfsberg, Carinthia, Austria
Hospital Hainburg, Hainburg An Der Donau, Lower Austria, Austria
Hospital Klosterneuburg, Internal Medicine, Klosterneuburg, Lower Austria, Austria
Hospital Krems, Krems, Lower Austria, Austria
Hospital Melk, Melk, Lower Austria, Austria
Hospital Mistelbach, Mistelbach, Lower Austria, Austria
Hospital Mödling, Mödling, Lower Austria, Austria
Hospital Neunkirchen, Neunkirchen, Lower Austria, Austria
Hospital Scheibbs, Scheibbs, Lower Austria, Austria
Hospital St. Poelten, St. Poelten, Lower Austria, Austria
Hospital Tulln, Tulln, Lower Austria, Austria
Hospital Waidhofen/Thaya, Waidhofen An Der Thaya, Lower Austria, Austria
Hospital of Wiener Neustadt, Wiener Neustadt, Lower Austria, Austria
Kardinal Schwarzenberg'sches Hospital, Schwarzach, Salzburg, Austria
State Hospital Feldbach, Feldbach, Styria, Austria
Gynaegological Medical University of Graz, Graz, Styria, Austria
Medical University of Graz, Oncology, Graz, Styria, Austria
State Hospital Leoben, Leoben, Styria, Austria
State Hospital Rottenmann, Rottenmann, Styria, Austria
Brustgesundheitszentrum-Süd Institut / Dr. Thiel, Weiz, Styria, Austria
District Hospital Hall in Tirol, Hall in Tirol, Tyrol, Austria
Gynaegological Medical University Innsbruck, Innsbruck, Tyrol, Austria
District Hospital Kufstein, Kufstein, Tyrol, Austria
District Hospital Lienz, Lienz, Tyrol, Austria
Hospital St. Vinzenz, Zams, Tyrol, Austria
State Hospital Bad Ischl, Bad Ischl, Upper Austria, Austria
State Hospital Freistadt, Freistadt, Upper Austria, Austria
State Hospital Gmunden, Gmunden, Upper Austria, Austria
State Hospital Kirchdorf, Kirchdorf, Upper Austria, Austria
Hospital BHS Linz, Linz, Upper Austria, Austria
Hospital Elisabethinen Linz, Linz, Upper Austria, Austria
General Hospital Linz, Linz, Upper Austria, Austria
Hospital BHB Linz, Linz, Upper Austria, Austria
Ordination Dr. Pöstlberger, Linz, Upper Austria, Austria
Hospital BHS Ried, Ried, Upper Austria, Austria
State Hospital Rohrbach, Rohrbach, Upper Austria, Austria
State Hospital Schärding, Schärding, Upper Austria, Austria
State Hospital Steyr, Steyr, Upper Austria, Austria
State Hospital Voecklabruck, Internal Medicine, Voecklabruck, Upper Austria, Austria
State Hospital Voecklabruck, Surgery Dept., Voecklabruck, Upper Austria, Austria
Klinikum Wels-Grieskirchen, Wels, Upper Austria, Austria
State Hospital Bregenz, Bregenz, Vorarlberg, Austria
State Hospital of Dornbirn, Dornbirn, Vorarlberg, Austria
State Hospital Feldkirch, Feldkirch, Vorarlberg, Austria
Paracelsus Medical University Salzburg - Oncology, Salzburg, , Austria
Hospital BHB Vienna, Surgery, Vienna, , Austria
Hospital Sanatorium Hera, Vienna, , Austria
Medical University of Vienna, General Hospital, Gynaecology and Obstetrics, Vienna, , Austria
Medical University of Vienna, General Hospital, Vienna, , Austria
Medical University Vienna, General Hospital, Vienna, , Austria
State Hospital Vienna-Hietzing, Vienna, , Austria
Hanusch Hospital, Vienna, , Austria
Wilheminenspital, Internal Medicin I, Vienna, , Austria
Practice Dr. Marschner, Freiburg, Baden-Wuerttemberg, Germany
Medical Care Center, Ulm, Baden-Wuerttemberg, Germany
Klinikum St. Marien, Amberg, Bavaria, Germany
Frauenklinik vom Roten Kreuz, Muenchen, Bavaria, Germany
Med. University of Munich, Munich, Bavaria, Germany
Elisabeth-Hospital, Kassel, Hesse, Germany
Internal-haematological Practice Oldenburg, Oldenburg, Lower Saxony, Germany
General Hospital Gifhorn, Gifhorn, Saxony, Germany
Medical University Kiel, Kiel, Schleswig-Holstein, Germany
Vivantes-Klinikum Friedrichshain, Berlin, , Germany
Contact Details
Name: Raimund Jakesz, MD
Affiliation: Austrian Breast & Colorectal Cancer Study Group
Role: PRINCIPAL_INVESTIGATOR
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