Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care, Treatment	Closed	19 to 59	Other	ABCSG-12 CZOL 446 1B 01, Zol-A-01, NCT00295646

Trial Description

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.

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

Raimund Jakesz, MD

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00295646
Information obtained from ClinicalTrials.gov on March 18, 2009