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Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid

Information source: Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: tamoxifen (Drug); anastrozole (Drug); zoledronic acid (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Austrian Breast & Colorectal Cancer Study Group

Official(s) and/or principal investigator(s):
Raimund Jakesz, MD, Principal Investigator, Affiliation: Austrian Breast & Colorectal Cancer Study Group

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.

Clinical Details

Official title: Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid, in Premenopausal, Hormone Receptor-positive Breast Cancer Patients (Stage I, II)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Comparison of tamoxifen with anastrozole in premenopausal patients with non-metastatic breast cancer and comparison of a subgroup additionally treated with zoledronate to a control subgroup without receiving zoledronate according to DFS.

Secondary outcome:

For the assessment of the recurrence free survival (RFS) patients receiving tamoxifen will be compared to patients receiving anastrozole and patients receiving zoledronate will be compared to controls, respectively.

For the assessment of the overall survival (OS) patients receiving tamoxifen will be compared to patients receiving anastrozole and patients receiving zoledronate will be compared to controls, respectively.

The objective is 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 anti-estrogen or aromatase inhibitor (AI).

Adverse and severe adverse events will be listed for all therapy subgroups "anastrozole / zoledronate" (AZ), "anastrozole / zoledronate control" (AC), "tamoxifen / zoledronate" (TZ), "tamoxifen / zoledronate control" (TC).

Detailed description: The trial is conducted as an open multi-center phase III study, in a two-factorial study design and according to 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 BMD measurements will be performed in a subgroup of patients (404 patients, enrolled in 3 centres).

Eligibility

Minimum age: 19 Years. Maximum age: 59 Years. Gender(s): Female.

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 and Contacts

Paracelsus Medical University Salzburg - Oncology, Salzburg 5020, Austria

Hanusch Hospital, Vienna 1140, Austria

Hospital BHB Vienna, Surgery, Vienna 1020, Austria

Hospital Sanatorium Hera, Vienna 1090, Austria

Medical University of Vienna, General Hospital, Vienna 1090, Austria

Medical University of Vienna, General Hospital, Gynaecology and Obstetrics, Vienna 1090, Austria

Medical University Vienna, General Hospital, Vienna 1090, Austria

State Hospital Vienna-Hietzing, Vienna 1130, Austria

Wilheminenspital, Internal Medicin I, Vienna 1160, Austria

Vivantes-Klinikum Friedrichshain, Berlin 10967, Germany

Practice Dr. Marschner, Freiburg, Baden-Wuerttemberg 79106, Germany

Medical Care Center, Ulm, Baden-Wuerttemberg 89073, Germany

Klinikum St. Marien, Amberg, Bavaria 92224, Germany

Frauenklinik vom Roten Kreuz, Muenchen, Bavaria 80637, Germany

Med. University of Munich, Munich, Bavaria 80337, Germany

Hospital of Guessing, Guessing, Burgenland 7540, Austria

Hospital Oberpullendorf, Oberpullendorf, Burgenland 7350, Austria

Hospital Oberwart, Oberwart, Burgenland 7400, Austria

State Hospital Klagenfurt, Klagenfurt, Carinthia 9026, Austria

State Hospital Klagenfurt, Surgery, Klagenfurt, Carinthia 9026, Austria

Hospital BHB St. Veit, St. Veit a. d. Glan, Carinthia 9300, Austria

Ordination Dr. Wette, St. Veit a. d. Glan, Carinthia 9300, Austria

Privat Hospital Villach, Villach, Carinthia 9504, Austria

State Hospital Villach, Villach, Carinthia 9500, Austria

State Hospital Wolfsberg, Wolfsberg, Carinthia 9400, Austria

Elisabeth-Hospital, Kassel, Hesse 34117, Germany

Hospital Hainburg, Hainburg, Lower Austria 2410, Austria

Hospital Klosterneuburg, Internal Medicine, Klosterneuburg, Lower Austria 3400, Austria

Hospital Krems, Krems, Lower Austria 3500, Austria

Hospital Melk, Melk, Lower Austria 3390, Austria

Hospital Mistelbach, Mistelbach, Lower Austria 2130, Austria

Hospital Moedling, Moedling, Lower Austria 2340, Austria

Hospital Neunkirchen, Neunkirchen, Lower Austria 2620, Austria

Hospital Scheibbs, Scheibbs, Lower Austria 3270, Austria

Hospital St. Poelten, St. Poelten, Lower Austria 3100, Austria

Hospital Tulln, Tulln, Lower Austria 3430, Austria

Hospital Waidhofen/Thaya, Waidhofen a. d. Thaya, Lower Austria 3830, Austria

Hospital of Wiener Neustadt, Wiener Neustadt, Lower Austria 2700, Austria

Internal-haematological Practice Oldenburg, Oldenburg, Lower Saxony 26121, Germany

Kardinal Schwarzenberg`sches Hospital, Schwarzach, Salzburg 5620, Austria

General Hospital Gifhorn, Gifhorn, Saxony 38518, Germany

Medical University Kiel, Kiel, Schleswig-Holstein 24105, Germany

State Hospital Feldbach, Feldbach, Styria 8330, Austria

Gynaegological Medical University of Graz, Graz, Styria 8036, Austria

Medical University of Graz, Oncology, Graz, Styria 8036, Austria

State Hospital Leoben, Leoben, Styria 8700, Austria

State Hospital Rottenmann, Rottenmann, Styria 8786, Austria

Ordination Dr. Thiel, Weiz, Styria 8160, Austria

District Hospital Hall in Tirol, Hall in Tirol, Tyrol 6060, Austria

Gynaegological Medical University Innsbruck, Innsbruck, Tyrol 6020, Austria

District Hospital Kufstein, Kufstein, Tyrol 6330, Austria

District Hospital Lienz, Lienz, Tyrol 9900, Austria

Hospital St. Vinzenz, Zams, Tyrol 6511, Austria

State Hospital Bad Ischl, Bad Ischl, Upper Austria 4820, Austria

State Hospital Freistadt, Freistadt, Upper Austria 4240, Austria

State Hospital Gmunden, Gmunden, Upper Austria 4810, Austria

State Hospital Kirchdorf, Kirchdorf, Upper Austria 4560, Austria

General Hospital Linz, Linz, Upper Austria 4020, Austria

Hospital BHB Linz, Linz, Upper Austria 4020, Austria

Hospital BHS Linz, Linz, Upper Austria 4010, Austria

Hospital Elisabethinen Linz, Linz, Upper Austria 4010, Austria

Ordination Dr. Pöstlberger, Linz, Upper Austria 4020, Austria

Hospital BHS Ried, Ried, Upper Austria 4910, Austria

State Hospital Rohrbach, Rohrbach, Upper Austria 4150, Austria

State Hospital Schaerding, Schaerding, Upper Austria 4780, Austria

State Hospital Steyr, Steyr, Upper Austria 4400, Austria

State Hospital Voecklabruck, Internal Medicine, Voecklabruck, Upper Austria 4840, Austria

State Hospital Voecklabruck, Surgery Dept., Voecklabruck, Upper Austria 4840, Austria

Klinikum Wels-Grieskirchen, Wels, Upper Austria 4600, Austria

State Hospital Bregenz, Bregenz, Vorarlberg 6900, Austria

State Hospital of Dornbirn, Dornbirn, Vorarlberg 6850, Austria

State Hospital Feldkirch, Feldkirch, Vorarlberg 6807, Austria

Additional Information

Click here for more information about this study: ABCSG-Studien follow-up

Starting date: June 1999
Last updated: August 3, 2015

Page last updated: August 23, 2015

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