Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid
NCT ID: NCT00295646
Last Updated: 2024-03-15
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1803 participants
INTERVENTIONAL
1999-06-30
2018-06-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Randomized Study Comparing Tamoxifen vs. Tamoxifen + Aminoglutethimide in Postmenopausal Receptor-positive Patients
NCT00309491
Arimidex/Tamoxifen Neo Adjuvant Study in Premenopausal Patients With Breast Cancer Under Anti Hormonal Treatment
NCT00605267
Effectiveness of Combination of Arimidex and Nolvadex in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women.
NCT00287534
Adjuvant Hormone Therapy in Treating Women With Operable Breast Cancer
NCT00002460
ABCSG 8 - Adjuvant Treatment in Patients With Hormone Receptor-positive Breast Cancer With Good to Moderate Differentiation.
NCT00291759
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AZ (Arimidex+Zoledronate)
Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid)
anastrozole
1 mg/d
zoledronic acid
4 mg q6m
goserelin
3.6 mg goserelin subcutaneously every 28 days
TZ (Tamoxifen+Zoledronate)
Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid)
tamoxifen
20 mg/d
zoledronic acid
4 mg q6m
goserelin
3.6 mg goserelin subcutaneously every 28 days
AC (Arimidex Control)
Study Drug Arimidex (Anastrozole)
anastrozole
1 mg/d
goserelin
3.6 mg goserelin subcutaneously every 28 days
TC (Tamoxifen Control)
Study Drug Nolvadex (Tamoxifen)
tamoxifen
20 mg/d
goserelin
3.6 mg goserelin subcutaneously every 28 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
tamoxifen
20 mg/d
anastrozole
1 mg/d
zoledronic acid
4 mg q6m
goserelin
3.6 mg goserelin subcutaneously every 28 days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Previous breast tumor irradiation
* Previous or concurrent chemotherapy (except for preoperative chemotherapy)
* Serum creatinine \> 1.5 x UNL or creatinine clearance \< 60 ml/min
19 Years
59 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Novartis Pharmaceuticals
INDUSTRY
Austrian Breast & Colorectal Cancer Study Group
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Raimund Jakesz, MD
Role: PRINCIPAL_INVESTIGATOR
Austrian Breast & Colorectal Cancer Study Group
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital of Guessing
Güssing, 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
Saint Veit A. D. Glan, Carinthia, Austria
Ordination Dr. Wette
Saint 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 St. Poelten
Sankt Pölten, Lower Austria, Austria
Hospital Scheibbs
Scheibbs, 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
Vöcklabruck, Upper Austria, Austria
State Hospital Voecklabruck, Surgery Dept.
Vöcklabruck, 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 im Breisgau, Baden-Wurttemberg, Germany
Medical Care Center
Ulm, Baden-Wurttemberg, Germany
Klinikum St. Marien
Amberg, Bavaria, Germany
Med. University of Munich
Munich, Bavaria, Germany
Frauenklinik vom Roten Kreuz
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gnant M, Mlineritsch B, Luschin-Ebengreuth G, Kainberger F, Kassmann H, Piswanger-Solkner JC, Seifert M, Ploner F, Menzel C, Dubsky P, Fitzal F, Bjelic-Radisic V, Steger G, Greil R, Marth C, Kubista E, Samonigg H, Wohlmuth P, Mittlbock M, Jakesz R; Austrian Breast and Colorectal Cancer Study Group (ABCSG). Adjuvant endocrine therapy plus zoledronic acid in premenopausal women with early-stage breast cancer: 5-year follow-up of the ABCSG-12 bone-mineral density substudy. Lancet Oncol. 2008 Sep;9(9):840-9. doi: 10.1016/S1470-2045(08)70204-3. Epub 2008 Aug 19.
Gnant MF, Mlineritsch B, Luschin-Ebengreuth G, Grampp S, Kaessmann H, Schmid M, Menzel C, Piswanger-Soelkner JC, Galid A, Mittlboeck M, Hausmaninger H, Jakesz R; Austrian Breast and Colorectal Cancer Study Group. Zoledronic acid prevents cancer treatment-induced bone loss in premenopausal women receiving adjuvant endocrine therapy for hormone-responsive breast cancer: a report from the Austrian Breast and Colorectal Cancer Study Group. J Clin Oncol. 2007 Mar 1;25(7):820-8. doi: 10.1200/JCO.2005.02.7102. Epub 2006 Dec 11.
Gnant M, Mlineritsch B, Schippinger W, Luschin-Ebengreuth G, Postlberger S, Menzel C, Jakesz R, Seifert M, Hubalek M, Bjelic-Radisic V, Samonigg H, Tausch C, Eidtmann H, Steger G, Kwasny W, Dubsky P, Fridrik M, Fitzal F, Stierer M, Rucklinger E, Greil R; ABCSG-12 Trial Investigators; Marth C. Endocrine therapy plus zoledronic acid in premenopausal breast cancer. N Engl J Med. 2009 Feb 12;360(7):679-91. doi: 10.1056/NEJMoa0806285.
Gnant M, Dubsky P, Fitzal F, Blaha P, Schoppmann S, Steger G, Marth C, Samonigg H, Huttner K, Fohler H, Ruecklinger E, Jakesz R, Greil R; Austrian Breast and Colorectal Cancer Study Group. Maintaining bone density in patients undergoing treatment for breast cancer: is there an adjuvant benefit? Clin Breast Cancer. 2009 Jun;9 Suppl 1:S18-27. doi: 10.3816/CBC.2009.s.002.
Gnant M. Can oral bisphosphonates really reduce the risk of breast cancer in healthy women? J Clin Oncol. 2010 Aug 1;28(22):3548-51. doi: 10.1200/JCO.2010.29.6327. Epub 2010 Jun 21. No abstract available.
Gnant M, Mlineritsch B, Stoeger H, Luschin-Ebengreuth G, Heck D, Menzel C, Jakesz R, Seifert M, Hubalek M, Pristauz G, Bauernhofer T, Eidtmann H, Eiermann W, Steger G, Kwasny W, Dubsky P, Hochreiner G, Forsthuber EP, Fesl C, Greil R; Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria. Adjuvant endocrine therapy plus zoledronic acid in premenopausal women with early-stage breast cancer: 62-month follow-up from the ABCSG-12 randomised trial. Lancet Oncol. 2011 Jul;12(7):631-41. doi: 10.1016/S1470-2045(11)70122-X. Epub 2011 Jun 5.
Gnant M. Zoledronic acid in breast cancer: latest findings and interpretations. Ther Adv Med Oncol. 2011 Nov;3(6):293-301. doi: 10.1177/1758834011420599.
Pfeiler G, Konigsberg R, Fesl C, Mlineritsch B, Stoeger H, Singer CF, Postlberger S, Steger GG, Seifert M, Dubsky P, Taucher S, Samonigg H, Bjelic-Radisic V, Greil R, Marth C, Gnant M. Impact of body mass index on the efficacy of endocrine therapy in premenopausal patients with breast cancer: an analysis of the prospective ABCSG-12 trial. J Clin Oncol. 2011 Jul 1;29(19):2653-9. doi: 10.1200/JCO.2010.33.2585. Epub 2011 May 9.
Ressler S, Mlineritsch B, Greil R. Zoledronic acid for adjuvant use in patients with breast cancer. Expert Rev Anticancer Ther. 2011 Mar;11(3):333-49. doi: 10.1586/era.11.13.
Hadji P, Coleman R, Gnant M, Green J. The impact of menopause on bone, zoledronic acid, and implications for breast cancer growth and metastasis. Ann Oncol. 2012 Nov;23(11):2782-2790. doi: 10.1093/annonc/mds169. Epub 2012 Jun 22.
Rugani P, Luschin G, Jakse N, Kirnbauer B, Lang U, Acham S. Prevalence of bisphosphonate-associated osteonecrosis of the jaw after intravenous zoledronate infusions in patients with early breast cancer. Clin Oral Investig. 2014;18(2):401-7. doi: 10.1007/s00784-013-1012-5. Epub 2013 Jun 10.
Gnant M, Mlineritsch B, Stoeger H, Luschin-Ebengreuth G, Knauer M, Moik M, Jakesz R, Seifert M, Taucher S, Bjelic-Radisic V, Balic M, Eidtmann H, Eiermann W, Steger G, Kwasny W, Dubsky P, Selim U, Fitzal F, Hochreiner G, Wette V, Sevelda P, Ploner F, Bartsch R, Fesl C, Greil R; Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria. Zoledronic acid combined with adjuvant endocrine therapy of tamoxifen versus anastrozol plus ovarian function suppression in premenopausal early breast cancer: final analysis of the Austrian Breast and Colorectal Cancer Study Group Trial 12. Ann Oncol. 2015 Feb;26(2):313-20. doi: 10.1093/annonc/mdu544. Epub 2014 Nov 17.
Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Adjuvant bisphosphonate treatment in early breast cancer: meta-analyses of individual patient data from randomised trials. Lancet. 2015 Oct 3;386(10001):1353-1361. doi: 10.1016/S0140-6736(15)60908-4. Epub 2015 Jul 23.
Lipton A, Gnant M, Aapro M. Managing aromatase inhibitor-associated bone loss in breast cancer. Womens Health (Lond). 2007 Jul;3(4):441-8. doi: 10.2217/17455057.3.4.441.
Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.
Beltran-Bless AA, Clemons MJ, Fesl C, Greil R, Pond GR, Balic M, Vandermeer L, Bjelic-Radisic V, Singer CF, Steger GG, Helfgott R, Egle D, Solkner L, Gampenrieder SP, Kacerovsky-Strobl S, Suppan C, Ritter M, Rinnerthaler G, Pfeiler G, Fohler H, Hlauschek D, Hilton J, Gnant M. Does the number of 6-monthly adjuvant zoledronate infusions received affect treatment efficacy for early breast cancer? A sub-study of ABCSG-12. Eur J Cancer. 2023 Feb;180:108-116. doi: 10.1016/j.ejca.2022.12.003. Epub 2022 Dec 10.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CZOL 446 1B 01
Identifier Type: OTHER
Identifier Source: secondary_id
Zol-A-01
Identifier Type: OTHER
Identifier Source: secondary_id
ABCSG-12
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.