Phase 3
N=1,803
Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00295646 ↗Enrolled (actual)
1,803
Serious AEs
17.6%
Results posted
Mar 2024
Primary outcome: Primary: Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) — NA; NA; NA; NA years — p=0.59
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- tamoxifen (Drug); anastrozole (Drug); zoledronic acid (Drug); goserelin (Other)
- Age
- Adult · 19+ yrs
- Sex
- Female
- Sponsor
- Austrian Breast & Colorectal Cancer Study Group
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) |
NA; NA; NA; NA | 0.59 |
| PRIMARY Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) |
NA; NA; NA; NA | 0.01 sig |
| SECONDARY Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Recurrence-free Survival (RFS) |
NA; NA; NA; NA | 0.53 |
| SECONDARY Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Recurrence-free Survival (RFS) |
NA; NA; NA; NA | 0.01 sig |
| SECONDARY Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Overall Survival (OS) |
NA; NA; NA; NA | 0.07 |
| SECONDARY Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Overall Survival (OS) |
NA; NA; NA; NA | 0.10 |
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.
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
Data sourced from ClinicalTrials.gov (NCT00295646). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.