Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
AstraZeneca
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00295646
First received: February 23, 2006
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: tamoxifen
Drug: anastrozole
Drug: zoledronic acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid, in Premenopausal, Hormone Receptor-positive Breast Cancer Patients (Stage I, II)

Resource links provided by NLM:


Further study details as provided by Austrian Breast & Colorectal Cancer Study Group:

Primary Outcome Measures:
  • 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. [ Time Frame: 28.05.2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 28.05.2008 ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 28.05.2008 ] [ Designated as safety issue: No ]
  • 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). [ Time Frame: 28.05.2008 ] [ Designated as safety issue: No ]
  • 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). [ Time Frame: 28.05.2008 ] [ Designated as safety issue: Yes ]

Enrollment: 1803
Study Start Date: June 1999
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AZ (Arimidex+Zoledronat)
Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate)
Drug: anastrozole
1 mg/d
Other Name: Arimidex
Drug: zoledronic acid
4 mg q6m
Other Name: Zoledronate, Zometa
Active Comparator: TZ (Tamoxifen+Zoledronate)
Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate)
Drug: tamoxifen
20 mg/d
Other Name: Nolvadex
Drug: zoledronic acid
4 mg q6m
Other Name: Zoledronate, Zometa
Active Comparator: AC (Arimidex Control)
Study Drug Arimidex (Anastrozole)
Drug: anastrozole
1 mg/d
Other Name: Arimidex
Active Comparator: TC (Tamoxifen Control)
Study Drug Nolvadex (Tamoxifen)
Drug: tamoxifen
20 mg/d
Other Name: Nolvadex

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

Ages Eligible for Study:   19 Years to 59 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295646

  Hide Study Locations
Locations
Austria
Hospital of Guessing
Guessing, Burgenland, Austria, 7540
Hospital Oberpullendorf
Oberpullendorf, Burgenland, Austria, 7350
Hospital Oberwart
Oberwart, Burgenland, Austria, 7400
State Hospital Klagenfurt, Surgery
Klagenfurt, Carinthia, Austria, 9026
State Hospital Klagenfurt
Klagenfurt, Carinthia, Austria, 9026
Hospital BHB St. Veit
St. Veit a. d. Glan, Carinthia, Austria, 9300
Ordination Dr. Wette
St. Veit a. d. Glan, Carinthia, Austria, 9300
State Hospital Villach
Villach, Carinthia, Austria, 9500
Privat Hospital Villach
Villach, Carinthia, Austria, 9504
State Hospital Wolfsberg
Wolfsberg, Carinthia, Austria, 9400
Hospital Gmuend
Gmuend, Lower Austria, Austria, 3952
Hospital Hainburg
Hainburg, Lower Austria, Austria, 2410
Hospital Klosterneuburg, Internal Medicine
Klosterneuburg, Lower Austria, Austria, 3400
Hospital Krems
Krems, Lower Austria, Austria, 3500
Hospital Melk
Melk, Lower Austria, Austria, 3390
Hospital Mistelbach
Mistelbach, Lower Austria, Austria, 2130
Hospital Moedling
Moedling, Lower Austria, Austria, 2340
Hospital Neunkirchen
Neunkirchen, Lower Austria, Austria, 2620
Hospital Scheibbs
Scheibbs, Lower Austria, Austria, 3270
Hospital St. Poelten
St. Poelten, Lower Austria, Austria, 3100
Hospital Tulln
Tulln, Lower Austria, Austria, 3430
Hospital Waidhofen/Thaya
Waidhofen a. d. Thaya, Lower Austria, Austria, 3830
Hospital of Wiener Neustadt
Wiener Neustadt, Lower Austria, Austria, 2700
Kardinal Schwarzenberg`sches Hospital
Schwarzach, Salzburg, Austria, 5620
State Hospital Feldbach
Feldbach, Styria, Austria, 8330
Gynaegological Medical University of Graz
Graz, Styria, Austria, 8036
Medical University of Graz, Oncology
Graz, Styria, Austria, 8036
State Hospital Leoben
Leoben, Styria, Austria, 8700
State Hospital Rottenmann
Rottenmann, Styria, Austria, 8786
Ordination Dr. Thiel
Weiz, Styria, Austria, 8160
District Hospital Hall in Tirol
Hall in Tirol, Tyrol, Austria, 6060
Gynaegological Medical University Innsbruck
Innsbruck, Tyrol, Austria, 6020
District Hospital Kufstein
Kufstein, Tyrol, Austria, 6330
District Hospital Lienz
Lienz, Tyrol, Austria, 9900
Hospital St. Vinzenz
Zams, Tyrol, Austria, 6511
State Hospital Bad Ischl
Bad Ischl, Upper Austria, Austria, 4820
State Hospital Freistadt
Freistadt, Upper Austria, Austria, 4240
State Hospital Gmunden
Gmunden, Upper Austria, Austria, 4810
State Hospital Kirchdorf
Kirchdorf, Upper Austria, Austria, 4560
Hospital BHB Linz
Linz, Upper Austria, Austria, 4020
General Hospital Linz
Linz, Upper Austria, Austria, 4020
Hospital BHS Linz
Linz, Upper Austria, Austria, 4010
Ordination Dr. Pöstlberger
Linz, Upper Austria, Austria, 4020
Hospital Elisabethinen Linz
Linz, Upper Austria, Austria, 4010
Hospital BHS Ried
Ried, Upper Austria, Austria, 4910
State Hospital Rohrbach
Rohrbach, Upper Austria, Austria, 4150
State Hospital Schaerding
Schaerding, Upper Austria, Austria, 4780
State Hospital Steyr
Steyr, Upper Austria, Austria, 4400
State Hospital Voecklabruck, Internal Medicine
Voecklabruck, Upper Austria, Austria, 4840
State Hospital Voecklabruck, Surgery Dept.
Voecklabruck, Upper Austria, Austria, 4840
Klinikum Wels-Grieskirchen
Wels, Upper Austria, Austria, 4600
State Hospital Bregenz
Bregenz, Vorarlberg, Austria, 6900
State Hospital of Dornbirn
Dornbirn, Vorarlberg, Austria, 6850
State Hospital Feldkirch
Feldkirch, Vorarlberg, Austria, 6807
Paracelsus Medical University Salzburg - Oncology
Salzburg, Austria, 5020
Hanusch Hospital
Vienna, Austria, 1140
Medical University of Vienna, General Hospital, Gynaecology and Obstetrics
Vienna, Austria, 1090
Hospital Sanatorium Hera
Vienna, Austria, 1090
Wilheminenspital, Internal Medicin I
Vienna, Austria, 1160
Hospital BHB Vienna, Surgery
Vienna, Austria, 1020
Medical University of Vienna, General Hospital
Vienna, Austria, 1090
State Hospital Vienna-Hietzing
Vienna, Austria, 1130
Medical University Vienna, General Hospital
Vienna, Austria, 1090
Germany
Practice Dr. Marschner
Freiburg, Baden-Wuerttemberg, Germany, 79106
Medical Care Center
Ulm, Baden-Wuerttemberg, Germany, 89073
Klinikum St. Marien
Amberg, Bavaria, Germany, 92224
Frauenklinik vom Roten Kreuz
Muenchen, Bavaria, Germany, 80637
Med. University of Munich
Munich, Bavaria, Germany, 80337
Elisabeth-Hospital
Kassel, Hesse, Germany, 34117
Internal-haematological Practice Oldenburg
Oldenburg, Lower Saxony, Germany, 26121
General Hospital Gifhorn
Gifhorn, Saxony, Germany, 38518
Medical University Kiel
Kiel, Schleswig-Holstein, Germany, 24105
Vivantes-Klinikum Friedrichshain
Berlin, Germany, 10967
Sponsors and Collaborators
Austrian Breast & Colorectal Cancer Study Group
AstraZeneca
Novartis Pharmaceuticals
Investigators
Principal Investigator: Raimund Jakesz, MD Austrian Breast & Colorectal Cancer Study Group
  More Information

Additional Information:
No publications provided by Austrian Breast & Colorectal Cancer Study Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier: NCT00295646     History of Changes
Other Study ID Numbers: ABCSG-12, CZOL 446 1B 01, Zol-A-01
Study First Received: February 23, 2006
Last Updated: July 29, 2013
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Austrian Breast & Colorectal Cancer Study Group:
ABCSG
12
Phase 3
breast cancer
anastrozole
tamoxifen
zoledronic acid
premenopausal
hormone receptor-positive
Stage I
Stage II
bone mineral density
BMD
bisphosphonate
zoledronate

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Anastrozole
Zoledronic acid
Diphosphonates
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014