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

February 23, 2006
July 29, 2013
June 1999
December 2014   (final data collection date for primary outcome measure)
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 ]
  • - To compare overall and recurrence-free survival between tamoxifen and anastrozole
  • - To compare bone loss reduction/prevention between zoledronic acid and no zoledronic acid
Complete list of historical versions of study NCT00295646 on ClinicalTrials.gov Archive Site
  • 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 ]
  • - To compare overall and recurrence-free survival between zoledronic acid and no zoledronic acid given with tamoxifen or anastrozole
  • - To compare bone metastasis development with zoledronic acid vs no zoledronic acid
Not Provided
Not Provided
 
Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid
Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid, in Premenopausal, Hormone Receptor-positive Breast Cancer Patients (Stage I, II)

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.

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: tamoxifen
    20 mg/d
    Other Name: Nolvadex
  • Drug: anastrozole
    1 mg/d
    Other Name: Arimidex
  • Drug: zoledronic acid
    4 mg q6m
    Other Name: Zoledronate, Zometa
  • Active Comparator: AZ (Arimidex+Zoledronat)
    Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate)
    Interventions:
    • Drug: anastrozole
    • Drug: zoledronic acid
  • Active Comparator: TZ (Tamoxifen+Zoledronate)
    Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate)
    Interventions:
    • Drug: tamoxifen
    • Drug: zoledronic acid
  • Active Comparator: AC (Arimidex Control)
    Study Drug Arimidex (Anastrozole)
    Intervention: Drug: anastrozole
  • Active Comparator: TC (Tamoxifen Control)
    Study Drug Nolvadex (Tamoxifen)
    Intervention: Drug: tamoxifen

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1803
June 2015
December 2014   (final data collection date for primary outcome measure)

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
Female
19 Years to 59 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
 
NCT00295646
ABCSG-12, CZOL 446 1B 01, Zol-A-01
Yes
Austrian Breast & Colorectal Cancer Study Group
Austrian Breast & Colorectal Cancer Study Group
  • AstraZeneca
  • Novartis Pharmaceuticals
Principal Investigator: Raimund Jakesz, MD Austrian Breast & Colorectal Cancer Study Group
Austrian Breast & Colorectal Cancer Study Group
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP