Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid

• Status: Completed
• Trial end date: 2018-06-26
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Austrian Breast & Colorectal Cancer Study Group
• Collaborators: AstraZeneca; Novartis Pharmaceuticals
• Treatments: Anastrozole; Diphosphonates; Tamoxifen; Zoledronic Acid

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