Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIISupportive care, TreatmentClosed19 to 59OtherABCSG-12
CZOL 446 1B 01, Zol-A-01, NCT00295646

Trial Description


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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Austrian Breast Cancer Study Group

  • AstraZeneca Pharmaceuticals LP
  • Novartis Pharmaceuticals Corporation
Raimund Jakesz, MD, Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00295646
ClinicalTrials.gov processed this data on April 09, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.